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Biogen Inc.(NasdaqGS:BIIB) dropped from Russell Top 200 Index

2022-06-24 00:00:00

Biogen Inc.(NasdaqGS:BIIB) dropped from Russell Top 200 Index

Biogen Inc.(NasdaqGS:BIIB) dropped from Russell Top 200 Value Index

2022-06-24 00:00:00

Biogen Inc.(NasdaqGS:BIIB) dropped from Russell Top 200 Value Index

Biogen Inc.(NasdaqGS:BIIB) added to Russell Midcap Index

2022-06-24 00:00:00

Biogen Inc.(NasdaqGS:BIIB) added to Russell Midcap Index

Biogen Inc.(NasdaqGS:BIIB) added to Russell Midcap Value Index

2022-06-24 00:00:00

Biogen Inc.(NasdaqGS:BIIB) added to Russell Midcap Value Index

Biogen and Happify Health Collaborates to Support Multiple Sclerosis Patients on Digital Platform

2022-06-22 13:00:00

Biogen and Happify Health announced a collaboration to provide a digital solution for patient education and engagement, powered by artificial intelligence (AI), to support people living with multiple sclerosis (MS). Through this collaboration, Biogen and Happify Health will help people with MS manage their care journey, improve their wellbeing, learn about treatment options, consult with experts, and connect with other people in the MS community for support. The Happify Health solution, which brings together a digital tool configured for MS and a care community (Kopa), offers holistic health and wellness support, with access to neurology providers (doctors, nurse practitioners, physicians assistants and nurses) as well as mental health specialists, dietitians, and rehabilitation professionals. The online community that recently launched provides a place for those living with MS to ask experts questions and discuss the physical and mental challenges they are facing with patients in similar stages. Happify Health uses its proprietary AI technology to personalize content to patients’ life stages, symptoms and interests. Biogen, a global leader in developing treatments for people living with serious neurological and neurodegenerative diseases, will provide support for the MS platform, including educational content and resources for the patient care journey. In addition to psoriasis and maternal health, MS is the third therapeutic area to be addressed through Happify Health's unique Sequence™ approach. Sequences are configured to support specific medical conditions and weave together components like evidence-based digital therapeutics, online communities, and coaching in one unified platform, with recommendations tailored for each individual.

Chirfi Guindo, Executive Vice President for Global Product Strategy and Commercialization Accepts A New Role Outside of Biogen, Inc, Effective June 30, 2022

2022-06-21 21:25:00

On June 21, 2022, Chirfi Guindo, Executive Vice President for Global Product Strategy and Commercialization announced that he has accepted a new role outside of Biogen Inc. His last day at the Company will be June 30, 2022.

Biogen Inc. Presents New Data from Clinical Studies Aimed at Assessing Remaining Unmet Needs for People Living with Spinal Muscular Atrophy and Evaluating the Potential Impact of SPINRAZA

2022-06-15 11:30:00

Biogen Inc. will present new data from clinical studies aimed at assessing remaining unmet needs for people living with spinal muscular atrophy (SMA) and evaluating the potential impact of SPINRAZA® (nusinersen) in different patient populations at the SMA Research & Clinical Care Meeting hosted by Cure SMA this week in Anaheim, Calif. SMA Research Updates: Growing enrollment in the RESPOND study indicate there are residual unmet clinical needs in infants and toddlers with SMA following treatment with Zolgensma® (onasemnogene abeparvovec). The Phase 4 study is evaluating the clinical benefit and safety of SPINRAZA in infants and toddlers with SMA who have unmet needs following treatment with the gene therapy. Since initial findings from nine patients were shared in March 2022, baseline and safety data from 16 patients enrolled in RESPOND (as of November 2021) are being presented. All enrolled study participants reported suboptimal clinical status across a variety of measures at baseline, with 13 of 16 showing this in multiple areas, including motor and respiratory functions and swallowing/feeding ability. After beginning SPINRAZA treatment, initial safety findings (median duration of 132.5 days) show three participants experienced a serious adverse event (AE) during the study period; none of these events were considered related to SPINRAZA treatment. The RESPOND study (NCT04488133) is currently enrolling participants at 20 sites worldwide. Biogen will also share final data from Part A of the ongoing, three-part DEVOTE study evaluating the safety and tolerability of investigational, higher doses of nusinersen. Results from Part A, an open-label safety evaluation period in children and teens with later-onset SMA, suggest that a higher dosing regimen (28 mg) of nusinersen leads to higher levels of the drug in the cerebrospinal fluid and is generally well-tolerated, with most AEs reported considered to be mild in severity. The most common AEs reported were headache and procedural pain. Two serious AEs (fall, femur fracture) were reported in one participant during the study period. No AEs were considered related to nusinersen and some were related to treatment administration. The totality of Part A data supports further development of a higher dose of nusinersen. Currently, Part B and Part C of DEVOTE evaluating an investigational, higher dose of nusinersen are enrolling at 52 sites worldwide. Featured SPINRAZA Data Presentations Include: Results From the End of Part A of the Ongoing 3-Part DEVOTE Study to Explore Higher Doses of Nusinersen in SMA- June 17, 2022. Baseline Characteristics and Initial Safety Results in RESPOND: A Phase 4 Study of Nusinersen in Children With SMA Who Received Onasemnogene Abeparvovec – June 17, 2022. The SPINRAZA clinical development program encompasses 10 clinical studies, which have included more than 300 individuals across a broad spectrum of patient populations,2 including two randomized controlled studies (ENDEAR and CHERISH). The ongoing SHINE and NURTURE open-label extension studies are evaluating the long-term impact of SPINRAZA. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.

Cure SMA, SMA’s Annual SMA Conference, Jun 15, 2022 through Jun 19, 2022

2022-06-10 04:42:00

Cure SMA, SMA’s Annual SMA Conference, Jun 15, 2022 through Jun 19, 2022. Venue: Disneyland Hotel, Anaheim, California, United States.

Biogen and Alectos Therapeutics Announce License and Collaboration Agreement for Al01811, A Novel Gba2 Inhibitor for the Potential Treatment of Parkinson's Disease

2022-06-06 11:30:00

Biogen and Alectos Therapeutics have entered into a license and collaboration agreement to develop and commercialize a novel preclinical selective GBA2 inhibitor, AL01811, which has first-in-class potential as an oral disease modifying treatment for patients with Parkinson's disease. This collaboration combines Alectos' expertise in small-molecule therapeutics with Biogen's development capabilities in movement disorders. Increasing evidence suggests that lysosomal dysfunction plays a key role in the pathology of neurodegenerative disease, including PD. Small-molecule GBA2 inhibitors have been shown to reduce lysosomal pH and increase levels of the lysosomal proton pump vATPase, which is involved in maintaining the acidic pH required for lysosomal function. Currently, there are no approved disease modifying therapies for PD, creating significant unmet needs for patients seeking to slow disease progression. If approved, AL01811 has the potential to improve the standard of care for movement disorders such as PD, which affects approximately 10 million patients worldwide. Under the terms of the agreement, Biogen will make an upfront payment of $15 million to Alectos Therapeutics for an exclusive global license to AL01811 and additional unnamed backup molecules. In addition, Alectos is eligible to receive up to $77.5M in potential development payments and $630M in potential commercial payments should the collaboration achieve certain milestones. Alectos is also eligible to receive tiered royalties in the high-single-digits to mid-teens. Moving forward, both companies will collaborate on preclinical activities for AL01811 and, once AL01811 is advanced to the clinic, Biogen will assume sole responsibility for all development, regulatory, manufacturing, and commercial activities and costs.

Biogen Inc. and Bio-Thera Solutions, Ltd. Present Positive Phase 3 Data for Tocilizumab Biosimilar Candidate At the Annual European Congress of Rheumatology (EULAR 2022)

2022-06-03 12:00:00

Biogen Inc. and Bio-Thera Solutions, Ltd. presented positive Phase 3 data for BIIB800 (BAT1806), a biosimilar candidate referencing ACTEMRA®/ROACTEMRA® (tocilizumab), anti-interleukin-6 receptor monoclonal antibody, at the Annual European Congress of Rheumatology (EULAR 2022). Data from the Phase 3 comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product. The double-blind 52-week Phase 3 study randomized 621 patients with moderate to severe rheumatoid arthritis to receive either BIIB800 or the reference tocilizumab administered intravenously every 4 weeks at a dose of 8 mg/kg for the first 24 weeks. The primary endpoints were ACR20* response at week 12 and week 24. The ACR20 response rates in the BIIB800 group and the reference tocilizumab group were 68.97% vs. 64.82% at week 12 and 69.89% vs. 67.94% at week 24. The estimated difference between the two groups were within the pre-defined equivalence margins (4.15% (95% CI - 3.63 to 11.93) at week 12 and 1.94% (90% CI -4.04 to 7.92; 95% CI -5.18 to 9.07) at week 24. The treatment groups were comparable in terms of serum trough tocilizumab levels, incidence of treatment emergent adverse events and anti-drug antibody positivity and hence demonstrated comparable pharmacokinetics, safety and immunogenicity. The abstract is available online at the website of EULAR 2022 which has been held both virtually through the Congress platform and on-site in Copenhagen, Denmark between June 1-4, 2022. ACTEMRA®/ROACTEMRA® is indicated for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome, systemic sclerosis-associated interstitial lung disease (approved by FDA) and coronavirus disease 2019 (COVID-19) (under emergency use authorization by FDA), and severe COVID-19 (approved by EMA). On April 8, 2021, Biogen and Bio-Thera Solutions, Ltd. entered into a commercialization and license agreement to develop, manufacture and commercialize BIIB800 (BAT1806). Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China (including Hong Kong, Macau and Taiwan).

Biogen Inc. Announces New 12-Month Data for Tofersen

2022-06-03 09:20:00

Biogen Inc. announced new 12-month data for tofersen, an investigational antisense drug for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The data show that earlier initiation of tofersen compared to delayed initiation (six months later in the open-label extension [OLE] study) slowed declines in clinical function, respiratory function, muscle strength, and quality of life. At the time of the analysis, because the majority of participants survived without permanent ventilation (PV), the median time to death or PV could not be estimated. However, early survival data suggest a lower risk of death or PV with earlier initiation of tofersen. These results are based on new integrated data from the pivotal Phase 3 VALOR study and its OLE study. At the time of the analysis, because the majority of participants survived without PV, the median time tdeath or PV anand median time to death, could not be estimated. However, early survival data suggest a lower risk of death or PV (Hazard ratio [HR] 0.36; 95% CI: 0.137, 0.941) and death (HR 0.27; 95% CI: 0.084, 0.890) with earlier initiation oftofersen. Biomarker Results The latest 12-month results show that reductions in total SOD1 protein (a marker of target engagement) and neurofilament (a marker of axonal injury and neurodegeneration) were sustained over time.

Biogen Inc. and Samsung Bioepis Co., Ltd.’ BYOOVIZ™ (Ranibizumab-Nuna) Launches in the United States

2022-06-02 12:00:00

Biogen Inc. and Samsung Bioepis Co. Ltd. announced that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i has been launched in the United States. Healthcare provider engagement, promotional activity, collaborations with professional societies and patient advocacy groups have commenced and BYOOVIZ will be commercially available on July 1, 2022, through major distributors across the U.S. The list price will be $1,130 per single use vial to administer 0.5mg via intravitreal injection, which is 40% lower than the current list price of LUCENTIS. The FDA approved BYOOVIZ in September 2021 for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Neovascular (wet) AMD, although less common than dry AMD, is responsible for the majority of the severe vision loss or blindness associated with AMD.ii Anti-VEGF therapies have become a standard of care treatment for wet AMD, but in real-world settings, costs related with wet AMD treatment often raise challenges in achieving optimal clinical outcomes.iii Biosimilars, which are biologics with similar efficacy and comparable safety to reference biologics,iv have the potential to alleviate the financial burden associated with current anti-VEGF therapies. BYOOVIZ is the first biosimilar launch in the U.S. under the Biogen and Samsung Bioepis’ partnership. In addition to the U.S., BYOOVIZ was also approved as the first ophthalmology biosimilar in Europe (2021), the United Kingdom (2021), and Canada (2022). The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar candidate referencing EYLEA® (aflibercept)v. Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization. About BYOOVIZ™ (ranibizumab-nuna): BYOOVIZ™ (ranibizumab-nuna) injection, for intravitreal use; BYOOVIZ™ (ranibizumab-nuna) is biosimilar to LUCENTIS® (ranibizumab injection); BYOOVIZ™, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD); Macular Edema Following Retinal Vein Occlusion (RVO); and Myopic Choroidal Neovascularization (mCNV). Select Important Safety Information - WARNING AND PRECAUTIONS: Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection; Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection; and There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints

2022-06-01 10:30:00

Sage Therapeutics, Inc. and Biogen Inc. announced that the Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. Women treated with zuranolone 50 mg (n=98) demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo (n=97) as measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. The least-squares (LS) mean (SE) CFB in HAMD-17 total score at Day 15 for women who received zuranolone 50 mg was -15.6 (0.82) compared with -11.6 (0.82) for women who received placebo (LS mean difference -4.0 points; p=0.0007). The study met all key secondary endpoints with rapid and statistically significant improvement in depressive symptoms as early as Day 3 for participants treated with zuranolone 50 mg compared to placebo, which was sustained at all measured timepoints through Day 45 as measured by CFB in HAMD-17 total score. In addition, the study demonstrated statistically significant improvement in the key secondary endpoint of change from baseline in the Clinical Global Impression Severity (CGI-S) scale at Day 15 for participants treated with zuranolone 50 mg as compared to placebo (zuranolone -2.2 vs. placebo -1.6, p= 0.0052). The CGI-S is a clinician-administered 7-point scale that rates the severity of a person’s disease at the time of assessment. Zuranolone is an investigational two-week, once-daily oral drug being developed for major depressive disorder (MDD) and PPD. The SKYLARK Study in PPD was a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of zuranolone 50 mg dosed once daily for 14 days compared to placebo. Women enrolled in the study (n=200) had a total score of equal to or greater than 26 at baseline in the HAMD-17 and were followed for up to 45 days. The study population included approximately 22% Black or African American women and 38% Hispanic or Latina women. Zuranolone 50 mg was generally well-tolerated and demonstrated a safety profile consistent with that observed in the clinical development program to date. In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. The most common TEAEs (>5% in the zuranolone 50 mg arm) were somnolence, dizziness, sedation, headache, diarrhea, nausea, urinary tract infection and COVID-19. No evidence of withdrawal symptoms or increased suicidal ideation or behavior were identified as assessed by the 20 item Physician Withdrawal Checklist and the Columbia Suicide Severity Rating Scale, respectively. PPD is one of the most common medical complications during and after pregnancy and is estimated to affect approximately one in eight women who have given birth in the U.S. or approximately 500,000women annually. Symptoms of PPD can include depressed mood, loss of interest in activities, changes in sleep patterns and appetite, decreased energy, feelings of guilt or worthlessness, trouble concentrating and in some cases thoughts of suicide. While recognized by the U.S. Department of Health and Human Services as a high-priority public health issue, screening rates vary and nearly 70% of women with PPD may go undiagnosed. The NEST clinical development program for zuranolone in PPD includes the SKYLARK and ROBIN Studies. The first study in the NEST program, the Phase 3 ROBIN Study, also met its primary endpoint. The ROBIN Study was a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and pharmacokinetics of zuranolone 30 mg in the treatment of PPD. The LANDSCAPE and NEST development program for zuranolone includes 7 clinical studies evaluating the safety and efficacy of zuranolone in MDD and PPD. Sage Therapeutics and Biogen have initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for zuranolone in the treatment of MDD and plan to complete the MDD NDA filing in the second half of 2022. An associated NDA filing for PPD is anticipated in early 2023.

Denali Therapeutics and Biogen Announce Initiation of Phase 2B Study of Lrrk2 Inhibitor in Parkinson's Disease

2022-05-31 12:00:00

Denali Therapeutics Inc. and Biogen Inc. announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 (DNL151), as compared to placebo in approximately 640 participants with early-stage Parkinson’s disease. LUMA is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of BIIB122 in people with early-stage Parkinson’s disease between the ages of 30 and 80. The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Participants will be randomized to receive oral BIIB122 or placebo once daily. BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali. Denali and Biogen are co-developing and co commercializing BIIB122 for the potential treatment of Parkinson’s disease. The BIIB122 clinical development program includes both the LUMA Phase 2b study and the Phase 3 LIGHTHOUSE study in individuals with Parkinson’s disease with LRRK2 pathogenic variants. Following discovery of the LRRK2 mutation as a pathogenic genetic factor for Parkinson’s disease, further research has uncovered that it has the potential to be a novel therapeutic target for Parkinson’s disease. Mutations in leucine-rich repeat kinase 2 (LRRK2) account for 4-5% of familial and 1-2% of sporadic Parkinson’s disease. BIIB122 is a selective, central nervous system-penetrant small molecule inhibitor of LRRK2 that is hypothesized to improve lysosomal dysfunction. BIIB122 is an investigational drug that is not approved by any regulatory authority, and its safety and efficacy have not been established.

Biogen Inc. Presents at ALS Drug Development Summit, May-24-2022 through May-26-2022

2022-05-30 11:39:00

Biogen Inc. Presents at ALS Drug Development Summit, May-24-2022 through May-26-2022. Venue: Boston, United States. Presentation Date & Speakers: May-25-2022, Stephanie Fradette, Senior Medical Director, Clinical Development.

Biogen Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-09-2022 11:30 AM

2022-05-27 06:08:00

Biogen Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-09-2022 11:30 AM. Venue: Marriott Marquis, New York City, New York, United States.

Biogen Inc. has announced a Fixed-Income Exchange Offer in the amount of $700.731 million.

2022-05-17 00:00:00

Biogen Inc. has announced a Fixed-Income Exchange Offer in the amount of $700.731 million. Security Name: 3.25% Senior Subordinated Unsecured Notes due February 15, 2051 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: $700.731 million Price\Range: 100% Security Features: Callable; Senior; Subordinated; Unsecured Coupon Type: Fixed Transaction Features: Exchange Offer

Biogen Inc. Presents at CHCI Issue Summits, May-17-2022

2022-05-16 18:03:00

Biogen Inc. Presents at CHCI Issue Summits, May-17-2022 . Venue: 600 14th Street NW, Washington, District Of Columbia, United States. Speakers: Wanda Castro-Borrero, Global Medical Head MS Franchise, Fumarates, Interferons & Fampyra.

Biogen Inc. Presents at Gene Therapy Analytical Development Europe, May-30-2022 through Jun-01-2022

2022-05-12 06:51:00

Biogen Inc. Presents at Gene Therapy Analytical Development Europe, May-30-2022 through Jun-01-2022. Venue: London, United Kingdom. Presentation Date & Speakers: Jun-01-2022, Simon Briggs, Head of Gene Therapy Technical Product Development. May-31-2022, Niamh Kinsella, Global Regulatory CMC Early Development Gene Therapy Lead.

Congressional Hispanic Caucus Institute, CHCI Issue Summits, May 17, 2022 through May 18, 2022

2022-05-10 19:40:00

Congressional Hispanic Caucus Institute, CHCI Issue Summits, May 17, 2022 through May 18, 2022. Venue: 600 14th Street NW, Washington, District Of Columbia, United States.

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway

2022-05-09 23:31:00

Eisai Co., Ltd. and Biogen announced that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aß) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.

Biogen and MedRhythms to Develop and Commercialize A Prescription Digital Therapeutic Targeting the Treatment of Gait Deficits in Multiple Sclerosis

2022-05-05 11:30:00

Biogen Inc. and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis (MS). The collaboration combines MedRhythms’ digital expertise with Biogen’s leadership and global footprint in MS in order to address significant unmet patient needs. MedRhythms is developing next-generation prescription digital therapeutics across a broad range of indications in neurology via a technology platform that leverages advancements in neuroscience and music to target improved walking and mobility. MR-004 is MedRhythms’ pipeline candidate in MS, which aims to improve gait and gait-related aspects of movement, potentially providing MS patients with improved independence related to mobility. If approved, MR-004 has the potential to become the first prescription digital therapeutic for gait deficit in MS. MedRhythms is currently conducting two ongoing feasibility studies for MR-004, and, based on the readout of the first study, plans to initiate a registrational trial in the near future. Under the terms of the agreement, Biogen will make an upfront payment of $3 million to MedRhythms. Should certain development and commercial milestones be achieved, MedRhythms will be eligible to receive up to $117.5 million in potential milestone payments. MedRhythms is also eligible to receive tiered royalties in the high-single digits to low-teens on potential global sales.

Michel Vounatsos to Step Down as Chief Executive Officer of Biogen

2022-05-05 00:15:00

Biogen Inc. announced that Chief Executive Officer Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what appears to be a final blow to its prospect of becoming a big seller. Vounatsos, who was named as the CEO in 2016, will continue in his role until a successor is appointed.

Tranche Update on Biogen Inc. (NasdaqGS:BIIB)'s Equity Buyback Plan announced on October 21, 2020.

2022-05-03 16:17:00

From January 1, 2022 to March 31, 2022, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has completed the repurchase of 7,648,931 shares, representing 5.05% for $2,200 million under the buyback announced on October 21, 2020.

Biogen Inc. Reaffirms Revenue Guidance for the Full Year 2022

2022-05-03 11:12:00

Biogen Inc. reaffirmed revenue guidance for the full year 2022. for the year, the company expects total revenue in the range of $9.7 billion to $10.0 billion.

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

2022-05-02 10:30:00

Sage Therapeutics, Inc. and Biogen Inc. initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once daily oral drug being developed for MDD and postpartum depression (PPD). The companies have submitted the nonclinical module of the NDA to the FDA and plan to submit the remaining components for the MDD filing in the second half of 2022. Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. The rolling submission process allows completed sections of an NDA to be submitted to the FDA for review on an ongoing basis. Zuranolone was granted Fast Track Designation by the FDA in 2017 in MDD and Breakthrough Therapy Designation in 2018. Sage and Biogen plan to submit an associated NDA filing for PPD in the first half of 2023.

Biogen Inc. - Shareholder/Analyst Call

2022-04-29 11:31:00

AGM

Biogen Inc., Annual General Meeting, Jun 15, 2022

2022-04-29 11:31:00

Biogen Inc., Annual General Meeting, Jun 15, 2022, at 09:00 US Eastern Standard Time. Agenda: To elect the 11 nominees identified in the accompanying Proxy Statement to its Board of Directors to serve for a one-year term extending until its 2023 annual meeting of stockholders and their successors are duly elected and qualified; to ratify the selection of PricewaterhouseCoopers LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2022; to hold an advisory vote on executive compensation; and to transact such other business as may be properly brought before the annual meeting and any adjournments or postponements.

Biogen Inc. Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022

2022-04-23 17:57:00

Biogen Inc. Presents at TIDES (Oligonucleotide & Peptide Therapeutics), May-05-2022 . Venue: Boston, Massachusetts, United States. Speakers: Dan Hill, Associate Director, Digital Development & Analytic, Firoz Antia, Executive Director, Head of Oligonucleotide Development, Michelle O'Brien, Director Global Regulatory Affairs CMC.

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022

2022-04-23 07:45:00

I.I.R Ltd., TIDES (Oligonucleotide & Peptide Therapeutics), May 05, 2022 through May 12, 2022. Venue: Boston, Massachusetts, United States.

Samsung Biologics Co.,Ltd. (KOSE:A207940) completed the acquisition of the remaining 49.9% stake in Samsungbioepis Co,.Ltd from Biogen Inc. (NasdaqGS:BIIB).

2022-04-20 00:00:00

Samsung Biologics Co.,Ltd. (KOSE:A207940) reached an agreement to acquire the remaining 49.9% stake in Samsungbioepis Co,.Ltd from Biogen Inc. (NasdaqGS:BIIB) for $2.3 billion on January 27, 2022. Samsung Biologics Co.,Ltd shall acquire 50% less 1 share equivalent to 10.341852 million held by Biogen Inc. The Board of Directors of Samsung Biologics has approved the transaction, in which payment for the shares will be made in installments over the next two years, and full ownership will take effect at the time the first payment of $1 billion is made. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones. Upon the acquisition of Biogen’s stake, the companies will continue with their exclusive agreements, including commercialization of their current portfolio. This includes marketed products BENEPALI® (etanercept), a biosimilar referencing ENBREL®, IMRALDITM (adalimumab), a biosimilar referencing Humira®, and FLIXABI® (infliximab), a biosimilar referencing Remicade®. Additionally, Biogen will also retain commercial rights for BYOOVIZTM (ranibizuman-nuna), an approved biosimilar referencing LUCENTIS® (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing EYLEA. Closing of the transaction is contingent on the effectiveness of a securities registration statement filed by Samsung Biologics and satisfaction of certain regulatory and other customary closing conditions. As on April 6, 2022, European Commission has approved the transaction. The Board of Samsung Biologics Co.,Ltd. has also agreed to raise capital of $2.5 billion by issuing new shares, the proceeds of which will be used to fund the company's strategic growth plans, including the purchase of the Samsung Bioepis shares. The transaction is expected to boost earnings growth of Samsung Biologics on a consolidated basis. The stake transfer will take place on April 30, 2022. Transaction projected to be accretive to earnings in 2022. Moelis & Company (NYSE:MC) acts as financial advisor to Biogen, inc. Kim & Chang and Anne Wachsmann and Nicolas Zacharie of Linklaters acted as legal advisors of Samsung Biologics. Samsung Biologics Co.,Ltd. (KOSE:A207940) completed the acquisition of the remaining 49.9% stake in Samsungbioepis Co,.Ltd from Biogen Inc. (NasdaqGS:BIIB) on April 20, 2022.

Biogen Inc. Presents at Wellcome Connecting Science | Target Validation using Genomics and Informatics (Virtual Conference), May-04-2022

2022-04-14 18:34:00

Biogen Inc. Presents at Wellcome Connecting Science | Target Validation using Genomics and Informatics (Virtual Conference), May-04-2022 . Venue: Wellcome Genome Campus, Hinxton, United Kingdom. Speakers: Adele Mitchell.

Wellcome Connecting Science, Wellcome Connecting Science | Target Validation using Genomics and Informatics (Virtual Conference), May 04, 2022 through May 06, 2022

2022-04-14 18:07:00

Wellcome Connecting Science, Wellcome Connecting Science | Target Validation using Genomics and Informatics (Virtual Conference), May 04, 2022 through May 06, 2022. Venue: Wellcome Genome Campus, Hinxton, United Kingdom.

Biogen Inc. Presents at Drug Discovery Chemistry Conference 2022, Apr-18-2022 through Apr-21-2022

2022-04-14 17:07:00

Biogen Inc. Presents at Drug Discovery Chemistry Conference 2022, Apr-18-2022 through Apr-21-2022. Presentation Date & Speakers: Apr-20-2022, Doug Johnson, Senior Director, Chemical Biology & Proteomics.

Cambridge Innovation Institute, LLC, Drug Discovery Chemistry Conference 2022, Apr 18, 2022 through Apr 21, 2022

2022-04-14 12:01:00

Cambridge Innovation Institute, LLC, Drug Discovery Chemistry Conference 2022, Apr 18, 2022 through Apr 21, 2022.

Hanson Wade Limited, Gene Therapy Analytical Development Europe, May 30, 2022 through Jun 01, 2022

2022-04-06 17:15:00

Hanson Wade Limited, Gene Therapy Analytical Development Europe, May 30, 2022 through Jun 01, 2022. Venue: London, United Kingdom.

Biogen Inc. to Report Q1, 2022 Results on May 03, 2022

2022-04-06 00:00:00

Biogen Inc. announced that they will report Q1, 2022 results Pre-Market on May 03, 2022

Biogen Inc., Q1 2022 Earnings Call, May 03, 2022

2022-04-06 00:00:00

Biogen Inc., Q1 2022 Earnings Call, May 03, 2022

Biogen Inc. Announces New Data from Portfolio of Multiple Sclerosis Therapies

2022-04-04 20:06:00

Biogen Inc. announced new data from its portfolio of multiple sclerosis (MS) therapies being presented at the American Academy of Neurology (AAN) 2022 Annual Meeting. The presentations include new real-world, long-term data on TYSABRI® (natalizumab), as well as persistence and adherence learnings with VUMERITY® (diroximel fumarate). Additional presentations highlight the use of digital tools to potentially predict MS disease progression. These data build on ongoing work to advance the understanding and treatment of serious neurological and neurodegenerative diseases, and highlight Biogen’s commitment to science that strives to address the diverse needs of people living with MS. Two presentations contribute to the understanding of extended interval dosing (EID) with intravenous (IV) natalizumab in real-world and clinical trial settings. An updated analysis of the U.S. TOUCH® (TYSABRI Outreach: Unified Commitment to Health) database as of June 30, 2021, confirms results from earlier analyses, which found that EID with IV administration of natalizumab is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) than the approved every four-week (Q4W) dosing. In the updated analysis, which included more patients and longer exposures, EID was associated with a significant 87% reduction (hazard ratio 0.127; P<0.0001) in the probability of PML in comparison to the approved Q4W dose. Primary results from the Phase 3b NOVA study of every six-week (Q6W) IV dosing with natalizumab were also presented during a platform session, showing that Q6W administration of natalizumab maintains control of MS disease activity in patients who switched to Q6W after at least one year of disease stability on the approved Q4W IV dosing schedule. Topline data were first reported in August 2021, and additional results were shared at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual congress last year. The approved dose of TYSABRI is 300mg on a Q4W dosing regimen. In addition to the data presented on Q6W IV dosing with natalizumab, a new analysis of the observational STRIVE study using the approved Q4W IV TYSABRI dosing schedule found that treatment-naïve patients with early relapsing-remitting multiple sclerosis (RRMS) had improved clinical outcomes in comparison with patients who had received prior disease-modifying therapies (DMTs). These findings provide useful information on the added clinical benefit that initiating treatment early in the disease course with TYSABRI may provide. At four years, the cumulative probability of 24-week confirmed disability worsening (CDW) was significantly lower in treatment-naïve patients than in patients with prior DMT treatment (11.5% vs 29.0%; P=0.0015). In the treatment of MS, high levels of adherence and persistence with DMTs are associated with improved clinical outcomes and reduced treatment costs.1 Two claims analyses from AcariaHealth Specialty Pharmacy Program and Optum showed high rates of persistence and adherence with VUMERITY, consistent with clinical trial experience and further supporting VUMERITY as a well-tolerated oral fumarate option due to its gastrointestinal (GI) tolerability profile. A retrospective analysis of the AcariaHealth Specialty Pharmacy Program included 1,143 patients who initiated therapy with VUMERITY between Dec. 1, 2019, and Jan. 30, 2021. Persistence as measured by the overall estimated proportion of patients remaining on VUMERITY at 16 months was 82.3%; 4.5% discontinued VUMERITY due to GI side effects. Adherence, as measured by proportion of days covered (PDC), was 90.8%, and 85.4% of patients achieved a PDC =80%. Consistent findings were also observed in a subgroup of 433 patients who switched from TECFIDERA® (dimethyl fumarate) to VUMERITY. An Optum claims analysis included 1,885 patients with at least one MS-related claim between Oct. 1, 2019, and March 31, 2021: 224 were treated with VUMERITY, 746 with TECFIDERA, 601 with teriflunomide, 182 with fingolimod and 132 with siponimod. Persistence and adherence rates for VUMERITY after 90 days were 84% and 88%, respectively, consistent with or higher than those for other DMTs; 79% of patients achieved a PDC =80%.

Biogen Submits Final Protocol for ADUHELM (aducanumab-avwa) Phase 4 Envision Trial to FDA

2022-03-30 11:30:00

Biogen Inc. has submitted the final study protocol for the confirmatory Phase 4 ENVISION trial to the U.S. Food and Drug Administration (FDA) for review and approval. This is in line with the company’s commitment to accelerate the timelines for the trial, including submitting the final study protocol to the FDA in March 2022, as previously announced. Biogen expects the first patient to enter screening in May 2022 and the trial’s primary completion approximately four years after the study begins. The confirmatory ENVISION trial is a requirement based on FDA’s accelerated approval of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease (Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease). The study, as previously announced, will be a global, placebo-controlled trial, aiming to enroll around 1,500 patients with early Alzheimer’s disease and confirmation of amyloid beta pathology. The company has also reaffirmed the trial’s goal of recruiting at least 18% of patients in the U.S. from Black/African American and Latino communities. To increase participation among historically underrepresented patients, Biogen is leveraging multiple initiatives and working with several community groups, such as the National Minority Quality Forum and others who have expertise and a commitment in helping to overcome traditional enrollment barriers for diverse populations. These efforts are being addressed by three key strategies: Selecting sites with diverse staff, located in communities of color, with access to diverse patient populations; Supporting trial sites in identification, outreach, and engagement of underrepresented communities; and Engaging with community and patient organizations to increase Alzheimer’s disease awareness, education, and access to research. The primary endpoint for the trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months, as announced in January 2022. The trial will also include a planned long-term extension to collect treatment data for up to 48 months. Secondary endpoints include changes in Amyloid Positron Emission Tomography (PET) and Tau PET, as well as the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).

Hagens Berman, National Trial Attorneys, Encourages Biogen Inc. Investors with Losses to Contact Firm’S Attorneys, Deadline Approaching in Securities Class Action

2022-03-29 13:36:00

Hagens Berman urges Biogen Inc. investors with significant losses to submit losses now. A securities fraud class action has been filed and certain investors may have valuable claims. Class Period: June 7, 2021 – Jan. 11, 2022. Lead Plaintiff Deadline: April 8, 2022. The lawsuit focuses on Biogen’s and senior management’s statements leading up to- and after- the June 7, 2021 announcement that the FDA approved Biogen’s ADUHELM for the treatment of Alzheimer’s and the treatment’s annual price tag would be $56,000. According to the complaint, defendants made false and misleading statements and/or failed to disclose that: (1) Biogen submitted the same data to the FDA for approval of ADUHELM that had already, in March 2019, showed the drug had insufficient clinical benefit and supported abandonment; (2) Biogen executives enlisted the FDA’s Director of the Office of Neuroscience (Billy Dunn) to find a path forward for approval; (3) Biogen and senior management waged an undisclosed lobbying campaign with the FDA that was instrumental to the decision to file and approve ADUHELM based on prior clinical data supporting abandonment of the drug; and (4) Medicare and third party payors were unlikely to pay for ADUHELM. During the seven months after the June 7 announcements, the financial press reported ADUHELM was a dangerous and ineffective treatment, hospital networks refused to prescribe it, major insurance companies refused to pay for it, FDA advisory panel members resigned in protest over its approval, members of Congress demanded explanations of how ADUHELM was approved, the FTC and SEC opened inquiries into the approval and marketing of ADUHELM, and the Center for Medicare and Medicaid Services announced in a draft opinion that it would only pay for ADUHELM under limited circumstances – for those patients in a hospital-sponsored clinical trial.

Biogen Inc. Presents at Pharma Manufacturing World Summit, Mar-29-2022

2022-03-29 08:36:00

Biogen Inc. Presents at Pharma Manufacturing World Summit, Mar-29-2022 . Venue: Boston Marriott Copley Place, Boston, Massachusetts, United States. Speakers: Shannon Holmes, Director, Product Development Quality.

Executive Platforms Inc., Pharma Manufacturing World Summit, Mar 29, 2022 through Mar 30, 2022

2022-03-21 14:57:00

Executive Platforms Inc., Pharma Manufacturing World Summit, Mar 29, 2022 through Mar 30, 2022. Venue: Boston Marriott Copley Place, Boston, Massachusetts, United States.

Alliance for Regenerative Medicine, Cell & Gene Meeting on the Mediterranean, Apr 19, 2022 through Apr 21, 2022

2022-02-26 07:53:00

Alliance for Regenerative Medicine, Cell & Gene Meeting on the Mediterranean, Apr 19, 2022 through Apr 21, 2022. Venue: Barcelona, Spain.

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Bronstein, Gewirtz & Grossman, LLC Announces Class Action Lawsuit Files Against Biogen, Inc

2022-02-09 15:00:00

Bronstein, Gewirtz & Grossman, LLC notified investors that a class action lawsuit has been filed against Biogen Inc. and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Biogen securities between October 22, 2019, and November 6, 2020, both dates inclusive (the "Class Period"). This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934. The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements and/or failed to disclose that: (1) the larger dataset did not provide necessary data regarding aducanumab's effectiveness; (2) the EMERGE study did not and would not provide necessary data regarding aducanumab's effectiveness; (3) the PRIME study did not and would not provide necessary data regarding aducanumab's effectiveness; (4) the data provided by the Company to the FDA'sPeripheral and Central Nervous System Drugs Advisory Committee did not support finding efficacy of aducanumab; and (5) as a result, defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

Block & Leviton LLP Files A Lawsuit Against Biogen, Inc. for Securities Law Violations

2022-02-07 23:04:00

Block & Leviton LLP announced that it has filed a class action lawsuit on behalf of shareholders against Biogen Inc. and certain of its executives for securities fraud. The complaint was brought in United States District Court for the District of Massachusetts and is captioned Oklahoma Firefighters Pension and Retirement System v. Biogen Inc., No. 1:22-cv-10200 (D. Mass.) and is brought on behalf of investors that incurred damages on their purchases in Biogen common stock between June 7, 2021 and January 11, 2022, inclusive (the Class Period). Investors who purchased Biogen shares between June 7, 2021 and January 11, 2022 and who lost money are strongly encouraged to contact Block & Leviton attorneys. The deadline to seek appointment as lead plaintiff is April 8, 2022. Biogen is a multinational biotechnology company well known for proprietary treatments for Multiple Sclerosis (MS) and other chronic conditions. In March 2019, Biogen announced it was abandoning Aduhelm, its potential blockbuster drug for treating Alzheimer’s disease. Contrary to this decision, a group of Biogen executives began to meet with the FDA’s Director of the Office of Neuroscience in an effort to gain FDA approval for Aduhelm, the lawsuit alleges. Six months after announcing it was abandoning Aduhelm as futile and that the drug failed to show any clinical benefit, Biogen announced it was submitting the drug for FDA approval, portraying the same supporting data as demonstrating the drug as safe and effective. Aduhelm was approved through the FDA’s Accelerated Approval process for the treatment of Alzheimer’s on June 7, 2021. Shares of Biogen stock skyrocketed by over $100 per share on June 7, 2021. However, over the next six months, investors learned that Aduhelm would not be the blockbuster drug to conquer Alzheimer’s or replace Biogen’s MS drug line-up because the drug was dangerous and ineffective, hospital networks refused to prescribe it, and major insurance companies refused to pay for it, as the lawsuit alleges. Members of the FDA advisory panel resigned in protest over Aduhelm’s approval and Congress demanded to know how the drug had been approved. By October 2021, Aduhelm was not selling well and in December other global regulators had denied its approval. Following the publication of a draft opinion by the Center for Medicare and Medicaid Services on January 11, 2022, Biogen’s stock price fell to $225 per share, more than 40% lower than where shares had traded on June 7, 2021 following the FDA approval announcement.

The Amyotrophic Lateral Sclerosis Association, ALS Drug Development Summit, May 24, 2022 through May 26, 2022

2022-02-07 17:12:00

The Amyotrophic Lateral Sclerosis Association, ALS Drug Development Summit, May 24, 2022 through May 26, 2022. Venue: Boston, United States.

Biogen Inc. Presents at SCOPE Summit 2022, Feb-08-2022 11:00 AM

2022-02-04 08:35:00

Biogen Inc. Presents at SCOPE Summit 2022, Feb-08-2022 11:00 AM. Venue: Orlanda, Florida, United States. Speakers: Charles Makin, Global Head, Medical Health Outcomes Research.

Biogen Inc. Provides Earnings Guidance for the Year 2022

2022-02-03 12:03:00

Biogen Inc. provided earnings guidance for the year 2022. The company expects full year 2022 revenue to be between $9.7 billion and $10.0 billion.

Biogen Exercises Option with Genentech to Participate in the Development and Commercialization of a Late-Stage Bispecific Antibody

2022-02-01 12:30:00

Biogen Inc. announced that it exercised its option to participate in the development and commercialization of mosunetuzumab. Biogen will pay a $30 million one-time option fee to Genentech as part of the companies’ long-standing collaboration on antibodies targeting CD20. Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody in development for the treatment of people with B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL)1 and diffuse large B-cell lymphoma (DLBCL). In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed/refractory (R/R) FL who have received at least two prior systemic therapies. Genentech plans to complete a Biologics License Application (BLA) submission to the FDA in the near future for approval consideration from the GO29781 study investigating mosunetuzumab in patients with R/R FL. If approved, mosunetuzumab has the potential to be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. Roche recently submitted the initial marketing authorization application for mosunetuzumab to the European Medicines Agency (EMA), with the hope to bring this drug as soon as possible to people with NHL. In addition, mosunetuzumab recently began a Phase 1b trial in patients with systemic lupus erythematosus. As a part of the option exercise, Biogen will pay a $30 million one-time option fee to Genentech and will pay for a portion of the mosunetuzumab development expenses incurred during 2021. Biogen will have joint decision-making rights related to development and commercialization of mosunetuzumab and Genentech will continue to lead the strategy and implementation of the program. Biogen will share in the operating profits and losses of mosunetuzumab in United States in the low to mid 30% range and is eligible to receive low single-digit royalties on sales outside the United States.

Biogen Announces Nancy Leaming and Brian Posner to Retire from Board of Directors

2022-01-31 12:30:00

Biogen Inc. announced that Nancy Leaming and Brian Posner will retire from Biogen’s Board of Directors, effective at the time of the Company’s 2022 annual meeting of stockholders.

Biogen Inc. and Eisai Co., Ltd. Provides Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM

2022-01-27 12:30:00

Biogen Inc. and Eisai Co., Ltd. announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint. Biogen aims to enroll 18% of U.S. participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen’s ongoing commitment to increase diversity in clinical trials. Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer’s disease trials, such as, lack of access to medical centers, familiarity with benefit/risk profile of treatment, and financial or logistical burdens. The companies also announced that the primary endpoint for the global, placebo-controlled ENVISION trial will be measured by the Clinical Dementia Rating–Sum of Boxes at 18 months after treatment initiation with ADUHELM. The CDR-SB endpoint is a validated measure of both cognition and function that is widely used in clinical trials of patients with early symptomatic Alzheimer’s disease, is consistent with ADUHELM’s Phase 3 EMERGE and ENGAGE studies, and capable of generating robust outcomes. The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early Alzheimer’s disease, with confirmation of amyloid beta pathology, to further strengthen the data provided by the study. Although ENVISION and other ADUHELM clinical trials are already planned or underway, the Centers for Medicare and Medicaid Services recently released a draft National Coverage Determination, which would restrict Medicare coverage of ADUHELM and other amyloid-targeting therapies to patients enrolled in an additional clinical trial. Biogen is committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer’s disease since 2003. In addition to the primary endpoint, CDR-SB, secondary endpoints include Alzheimer's Disease Assessment Scale-Cognitive Subscale, Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version Integrated Alzheimer's Disease Rating Scale, Mini-Mental State Examination and Neuropsychiatric Inventory. The initiation of patient screening for ENVISION is planned for May 2022. Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins. The companies are grateful to the healthcare professionals, medical centers, patients and families who will participate in this trial.

Samsung Biologics Co.,Ltd. (KOSE:A207940) reached an agreement to acquire the remaining 49.9% stake in Samsungbioepis Co,.Ltd from Biogen Inc. (NasdaqGS:BIIB) for $2.3 billion.

2022-01-27 00:00:00

Samsung Biologics Co.,Ltd. (KOSE:A207940) reached an agreement to acquire the remaining 49.9% stake in Samsungbioepis Co,.Ltd from Biogen Inc. (NasdaqGS:BIIB) for $2.3 billion on January 27, 2022. Samsung Biologics Co.,Ltd shall acquire 50% less 1 share equivalent to 10.341852 million held by Biogen Inc. The Board of Directors of Samsung Biologics has approved the transaction, in which payment for the shares will be made in installments over the next two years, and full ownership will take effect at the time the first payment of $1 billion is made. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones. Upon the acquisition of Biogen’s stake, the companies will continue with their exclusive agreements, including commercialization of their current portfolio. This includes marketed products BENEPALI® (etanercept), a biosimilar referencing ENBREL®, IMRALDITM (adalimumab), a biosimilar referencing Humira®, and FLIXABI® (infliximab), a biosimilar referencing Remicade®. Additionally, Biogen will also retain commercial rights for BYOOVIZTM (ranibizuman-nuna), an approved biosimilar referencing LUCENTIS® (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing EYLEA. Closing of the transaction is contingent on the effectiveness of a securities registration statement filed by Samsung Biologics and satisfaction of certain regulatory and other customary closing conditions. As on April 6, 2022, European Commission has approved the transaction. The Board of Samsung Biologics Co.,Ltd. has also agreed to raise capital of $2.5 billion by issuing new shares, the proceeds of which will be used to fund the company's strategic growth plans, including the purchase of the Samsung Bioepis shares. The transaction is expected to boost earnings growth of Samsung Biologics on a consolidated basis. The stake transfer will take place on April 30, 2022. Transaction projected to be accretive to earnings in 2022. Moelis & Company (NYSE:MC) acts as financial advisor to Biogen, inc. Kim & Chang and Anne Wachsmann and Nicolas Zacharie of Linklaters acted as legal advisors of Samsung Biologics.

Biogen Inc. to Report Q4, 2021 Results on Feb 03, 2022

2022-01-20 00:00:00

Biogen Inc. announced that they will report Q4, 2021 results Pre-Market on Feb 03, 2022

Biogen Inc., Q4 2021 Earnings Call, Feb 03, 2022

2022-01-20 00:00:00

Biogen Inc., Q4 2021 Earnings Call, Feb 03, 2022

Biogen Inc. Exercises Option with Ionis Pharmaceuticals, Inc. to Develop and Commercialize Investigational ASO for SMA

2022-01-04 12:34:00

Biogen Inc. and Ionis Pharmaceuticals, Inc. announced that Biogen exercised its option to obtain from Ionis a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115/ION306. The companies have a broad strategic collaboration to develop novel therapies to treat neurological disorders. BIIB115 is an investigational antisense oligonucleotide in development for spinal muscular atrophy that may have the potential to help address additional unmet needs of patients as well as to be administered at extended dosing intervals. Biogen plans to advance BIIB115 to clinical trials to investigate safety, tolerability, pharmacokinetics, and efficacy. SMA is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy. People with SMA do not produce enough survival motor neuron protein, which is critical for the maintenance of motor neurons. BIIB115 is designed to target a root cause of SMA by increasing the production of functional SMN protein. As a part of the option exercise, Biogen made a one-time $60 million payment to Ionis in the fourth quarter of 2021. Future payments may include potential post-licensing development, regulatory and commercial milestone payments and royalties on annual worldwide net sales. Biogen will be solely responsible for the costs and expenses related to the development, manufacturing and potential future commercialization of BIIB115 following the option exercise. The SPINRAZA clinical development program encompasses 10 clinical studies, which have included more than 300 individuals across a broad spectrum of patient populations1, including two randomized controlled studies. The ongoing SHINE and NURTURE open-label extension studies are evaluating the long-term impact of SPINRAZA. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.

Samsung Biologics Denies Takeover Interest for Biogen

2021-12-30 12:28:00

Samsung Biologics Co.,Ltd. (KOSE:A207940) said in a regulatory filing on December 30, 2021 that a report saying Samsung Group is in talks to acquire U.S. drugmaker Biogen Inc. (NasdaqGS:BIIB) is not true. South Korean newspaper Korea Economic Daily reported earlier that Samsung is in talks to buy Biogen, citing investment banking sources.

Biogen Inc. and Eisai Company, Ltd. Announces Japan’S Ndc of the Pharmaceutical Affairs and Food Sanitation Council Seeks Additional Data; Aducanumab Remains Under Review

2021-12-23 00:00:00

Biogen Inc. and Eisai Company, Ltd. announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council that advises the Ministry of Health, Labour and Welfare (MHLW) in Japan has decided to continue deliberations on the application for the manufacturing and marketing approval of aducanumab for the treatment of Alzheimer’s disease. The NDC is seeking additional data to be submitted as part of this process. The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai remain committed to bringing aducanumab to patients in Japan expeditiously. In the United States, ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects. As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of aducanumab.

Biogen Inc Announces Japan's First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council Seeks Additional Data

2021-12-22 12:30:00

Biogen Inc. announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council that advises the Ministry of Health, Labour and Welfare (MHLW) in Japan has decided to continue deliberations on the application for the manufacturing and marketing approval of aducanumab for the treatment of Alzheimer’s disease. The NDC is seeking additional data to be submitted as part of this process. The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai remain committed to bringing aducanumab to patients in Japan expeditiously. In the United States, ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). ADUHELM is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline. ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.

Biogen Announces Reduced Price for ADUHELM® to Improve Access for Patients with Early Alzheimer’s Disease

2021-12-20 12:00:00

Biogen Inc. announced that, effective January 1, 2022, it will reduce the wholesale acquisition cost (WAC) of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in the United States by approximately 50%. For a patient of average weight (74 kg), the yearly cost at the maintenance dose (10 mg/kg) will be $28,200. Biogen is taking this action with the goal of lowering out-of-pocket expenses for patients and reducing the potential financial implications for the U.S. healthcare system. ADUHELM’s reduced price takes into consideration the questions raised about this first class of therapies, the potential eligible population and revised pharmaco-economic assumptions. Biogen believes with insurance coverage, and access to diagnostics and specialized centers, approximately 50,000 patients may initiate treatment with ADUHELM in 2022. Biogen also announced that it will implement a series of cost-reduction measures in 2022 to better align its costs with its revenue base, which is expected to be impacted by the continued entry of generics in multiple sclerosis, as well as the delayed uptake of ADUHELM. The cost-reduction measures are estimated to yield approximately $500 million in annualized savings, a significant portion of which will be realized in 2022. A portion of these savings will be offset by investments in Biogen’s pipeline and strategic initiatives. Further details will be finalized in the coming weeks and will be communicated in the first quarter of 2022.

Biogen Inc. and Eisai Co., Ltd. Announces Update on Regulatory Submission for Aducanumab in the European Union

2021-12-17 11:43:00

Biogen Inc. and Eisai Co., Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease known as mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia. This decision is aligned to the negative trend vote of the committee in November 2021. Biogen will seek a re-examination of the opinion by the CHMP. The European Commission’s regulations1 allow an applicant to request a re-examination of a CHMP opinion, followed by submission of documentation with detailed grounds for the request. The Committee has 60 days after receipt of this documentation to re-examine their opinion. The MAA included efficacy, safety and biomarker data from a global, multi-study clinical development program which included approximately 3,600 patients in more than 20 countries. In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use as the first Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. ADUHELM is also approved in the United Arab Emirates (UAE).

Biogen Inc. Updates on the Phase 4 Confirmatory Study of ADUHELM

2021-12-16 12:00:00

Biogen Inc. provided an important update on the continuing progress of the Phase 4 post-marketing confirmatory study of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease. The companies anticipate submitting the final protocol for review to the U.S. Food and Drug Administration (FDA) in March 2022, with the initiation of patient screening in May 2022. The study is a post-marketing requirement of the FDA’s accelerated approval and will be a global, placebo-controlled trial, aiming to enroll more than 1,300 early Alzheimer’s disease patients, with a primary clinical endpoint at 18 months after treatment initiation. Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins. The trial will also include a long-term extension to collect longer-term treatment data for up to 48 months.

Biogen Inc. and TheraPanacea Announce New Collaboration with Potential to Advance Digital Health for Personalized Medicine in Neuroscience

2021-12-14 12:00:00

Biogen Inc. and TheraPanacea announced that they have entered into a collaboration focused on multiple therapeutic areas in neuroscience, to further build on the companies’ existing relationship. The aim is to leverage machine learning (ML) and artificial intelligence (AI) analysis to develop digital health solutions that may improve patient care, accelerate drug development, and further the understanding of the underlying pathologies of neurological diseases. By harnessing ML and AI to draw meaning from medical imaging and other clinically relevant data sources, there is potential to improve disease understanding and enable more personalized clinical trial design. This could result in shortening drug development cycles, lowering associated costs, and increasing probability of success. At the same time, these digital health solutions have the potential to support more informed clinical decisions and could lead to improved health outcomes for patients. Under the terms of the agreement, Biogen will invest up to $15 million in exchange for TheraPanacea convertible debt. The agreement also provides for up to approximately $41 million (based on current exchange rates) in milestone payments contingent upon the achievement of certain research and development milestones. In addition, Biogen gains exclusive rights to TheraPanacea’s technology in neuroscience. To meet the goals of this collaboration, TheraPanacea will invest in expanding its existing operations and workforce in Europe.

Sage Therapeutics and Biogen Announce New Analyses from the LANDSCAPE Clinical Development Program of Zuranolone in MDD Presented at the American College of Neuropsychopharmacology Congress

2021-12-08 11:30:00

Sage Therapeutics, Inc. and Biogen Inc. announced new data from the LANDSCAPE clinical program evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) presented at the American College of Neuropsychopharmacology (ACNP) Congress taking place December 5-8 in San Juan, Puerto Rico. Data from the SHORELINE and WATERFALL Studies in the LANDSCAPE clinical program further the understanding of the potential efficacy and safety profile of zuranolone for the treatment of MDD. Across the studies, zuranolone treatment led to improvements in depressive symptoms as well as in symptoms of elevated anxiety as assessed by multiple scales (HAMD-17, MADRS and HAM-A, respectively). In the WATERFALL Study, a rapid onset of effect in HAMD-17 was observed compared to placebo as early as Day 3, reaching statistical significance, followed by a stabilization of depressive symptoms through the follow-up period. Zuranolone has demonstrated a consistent safety profile in the totality of clinical data to date, with no increased incidence of adverse events (AEs) of weight gain, sexual dysfunction, or sleep disruption relative to placebo, symptoms that are often the cause of standard of care antidepressant discontinuation. In an analysis of a subgroup of patients (N=96) over the age of 65 in the SHORELINE Study, zuranolone efficacy and safety results for the initial 2-week dose treatment course were similar to that of the general study population. At the time of the analysis, retreatment data were only available for the zuranolone 30 mg cohort of the SHORELINE Study. In a subgroup of patients 65 years and older who responded to the initial 2-week treatment course of zuranolone 30 mg, and were followed for up to one year in the SHORELINE Study, more than half did not receive a second course of treatment during their time in the study. ACNP presentations included data from the WATERFALL Study, a Phase 3 placebo-controlled trial that evaluated the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as well as the ongoing open-label SHORELINE Study in MDD. In an oral session, an analysis from the WATERFALL Study assessing zuranolone (50 mg) on symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) showed improvements in symptoms of anxiety compared with placebo at Days 8 and 15. Additional data presented provided an efficacy analysis from the WATERFALL Study as measured by the Montgomery- ..sberg Depression Rating Scale (MADRS) total score, which addresses core mood symptoms such as sadness, lack of energy, and suicidal thoughts. The group of patients receiving zuranolone (50 mg) showed rapid improvements in depressive symptoms and anxiety symptoms, as early as the first measured timepoint (Day 3 for HAMD-17 and Day 8 for HAM-A). Similar results have been observed across the LANDSCAPE program. Additionally, data from the SHORELINE Study support the potential of zuranolone as an oral, as-needed treatment for patients with MDD, including those age 65 and older.

Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD

2021-12-01 11:30:00

Sage Therapeutics, Inc. and Biogen Inc. announced 12-month data for the cohort of patients (n=199), who received zuranolone 50 mg once nightly for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study and had the opportunity to be followed for 12-months. The SHORELINE Study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with major depressive disorder (MDD) and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year. For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received. Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms and a well-tolerated safety profile throughout the LANDSCAPE clinical program. Secondary endpoints included the percentage of patients who received repeat dosing with zuranolone as well as response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression (HAMD-17). In the zuranolone 50 mg cohort, nearly 75% of patients responded to the initial 2-week treatment course. Of those who responded to the initial course and continued in the study, approximately 80% of those patients received at most one additional zuranolone treatment during their time in the study. The SHORELINE Study, with nearly 1,000 patients enrolled to date, is comprised of multiple cohorts, including a completed cohort with zuranolone 30 mg as a starting dose (data previously reported in 2020 and earlier in 2021) and an ongoing cohort with zuranolone 50 mg as a starting dose; both cohorts are administered zuranolone once nightly for 14 days. Enrollment of an anticipated 300 additional patients in the 50 mg cohort is ongoing. The study provides real-world insight into the potential use of zuranolone, if approved, as an as-needed treatment for MDD and builds on the data assembled in the LANDSCAPE clinical program to date. Data from the LANDSCAPE clinical program has been presented at numerous medical and scientific conferences and the Companies plan to present additional data from the ongoing SHORELINE Study in future scientific forums.

Biogen Inc. and Eisai Co., Ltd. Announces an Update on the Ongoing Review of the Marketing Authorization Application for Aducanumab 100 mg/mL Concentrate Solution

2021-11-17 12:30:00

Biogen Inc. and Eisai Co., Ltd. announced an update on the ongoing review of the Marketing Authorization Application for aducanumab 100 mg/mL concentrate solution for infusion for the treatment of Alzheimer’s disease by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following an oral explanation held at the November meeting of the CHMP, Biogen received a negative trend vote on the aducanumab Marketing Authorization Application. The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting (December 13-16, 2021). Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe.

The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

2021-11-16 14:20:00

Biogen Inc. announced that the European Commission (EC) has granted marketing authorization for VUMERITY® (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS). VUMERITY is a next-generation fumarate that offers the convenience of an oral medication with the established efficacy and well-characterized safety of TECFIDERA® (dimethyl fumarate). Globally, an estimated 2.8 million people live with MS, with more than 1 million people in Europe living with the disease. The EC’s approval of VUMERITY is based on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied in part on the well-established long-term efficacy and safety profile of TECFIDERA. The approval was also based on findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center Phase 3 study to evaluate the gastrointestinal (GI) tolerability of VUMERITY compared to TECFIDERA in patients with relapsing-remitting MS. In EVOLVE-MS-2, the rate of overall treatment discontinuation was lower in participants treated with VUMERITY compared to those treated with TECFIDERA (1.6% compared to 6%, respectively). The difference in the discontinuation rates due to GI tolerability was 0.8% for VUMERITY compared to 4.8% for TECFIDERA. Additionally, flushing was reported in 32.8% of VUMERITY-treated patients and in 40.6% of TECFIDERA treated patients. There were no serious events of flushing or discontinuations due to flushing in the study.

Biogen Inc. Announces Executive Changes

2021-11-16 00:44:00

Biogen Inc. announced that Alfred “Al” W. Sandrock, Jr., M.D., Ph.D., Head of Research & Development, will retire from the Company effective December 31, 2021. Priya Singhal, M.D., M.P.H., Head of Global Safety and Regulatory Sciences, also with oversight responsibility for Japan and China R&D, will assume Dr. Sandrock’s duties as Head of Research & Development on an interim basis until a permanent successor is identified.

Biogen Inc. and Eisai Co., Ltd. Announce New Phase 3 Data Show Positive Correlation Between ADUHELM™ Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer’s Disease

2021-11-11 22:10:00

Biogen Inc. and Eisai Co., Ltd. announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the ADUHELM™ (aducanumab-avwa) Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in Alzheimer’s disease. Reductions in plasma p-tau181 were also correlated with a lowering of amyloid beta plaque. The pre-specified analysis of plasma samples was conducted by an independent lab, drawing from the two pivotal ADUHELM Phase 3 EMERGE and ENGAGE trials. The findings were presented at the Clinical Trials on Alzheimer’s Disease conference (CTAD), held November 9-12 virtually and in Boston, Massachusetts. The analysis highlighted that ADUHELM significantly reduced tau pathology, a defining feature of Alzheimer’s disease, as measured by plasma p-tau181, when compared to placebo. The effect was greater with higher doses and longer duration of ADUHELM treatment. Greater reduction in plasma p-tau181 also had a statistically significant correlation with less decline in cognition and function in ADUHELM-treated patients. Furthermore, the analysis demonstrated a statistically significant correlation between change in plasma p-tau181 and lowering of amyloid beta plaque, showing the effect of ADUHELM on the two core pathological features of Alzheimer’s disease. The findings showed that ADUHELM significantly lowered plasma p-tau181 in a dose- and time-dependent manner vs. placebo in both Phase 3 trials. In the EMERGE high-dose group, p-tau decreased 13% from baseline (p<0.001), while placebo rose 8%; in the ENGAGE high-dose group, p-tau decreased 16% from baseline (p<0.001), while placebo rose 9%. Greater reduction in plasma p-tau181 was correlated with less clinical decline in all four clinical outcome measures in the Phase 3 trials. Correlation values across these endpoints were as follows for EMERGE and ENGAGE, respectively: Clinical Dementia Rating Sum of Boxes Score (CDR-SB) R = 0.11 (p = 0.0166) and R = 0.14 (p = 0.0005); Mini-Mental State Examination (MMSE) R = -0.21 (p < 0.0001) and R = -0.15 (p = 0.0002); Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13) R = 0.17 (p = 0.0001) and R = 0.15 (p = 0.0002); and Alzheimer’s Disease Cooperative Study/Activities of Daily Living scale adapted for MCI (ADCS-ADL-MCI) R = -0.12 (p = 0.0086) and R = -0.14 (p = 0.0010). Changes in plasma p-tau181 was also significantly correlated with change in amyloid beta positron emission tomography (PET) standardized uptake value ratio (SUVR): EMERGE R = 0.38, p < 0.0001; ENGAGE R = 0.42, p < 0.0001. The two pathological hallmarks of Alzheimer’s disease—amyloid beta plaque and neurofibrillary tangles (composed of abnormal p-tau)—disrupt communication between neurons, which leads to the loss of brain function, as well as neurodegeneration and clinical decline, which can begin in the early stages of Alzheimer’s disease. Biogen also presented data from the Phase 3b redosing study, EMBARK, which examined the impact of patients with Alzheimer’s disease stopping ADUHELM treatment for an extended period of time (average length of 1.7 years) before re-initiating treatment. The study showed that reductions in amyloid beta plaque were maintained in the high-dose group during the treatment gap period compared to the placebo group. Although the disease continued to progress after treatment discontinuation, numerical differences in favor of ADUHELM were maintained across clinical endpoints. The EMBARK baseline data underscore that further scientific evidence is needed to better understand the impact of discontinuation from anti-amyloid treatment and the role that other underlying pathological processes may play in disease progression. EMBARK is not a randomized study and there may be selection bias for the enrolling patients; Interpretation of these data must weigh the potential influence of the heterogeneity of dose, duration of exposure, and treatment gap periods across individuals in the study. The analysis is from the large clinical trial dataset available in early Alzheimer’s disease, which included 1,856 screened patients from EMERGE, ENGAGE, PRIME and EVOLVE. ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Aducanumab-avwa is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline. ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects. As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of aducanumab.

Eisai Co., Ltd. and Biogen Inc. Announces Presentation About Exploring Use of Plasma-Based Biomarkers in Phase 3 AHEAD 3-45 Study of Lecanemab at Clinical Trials on Alzheimer's Disease Conference

2021-11-11 17:00:00

Eisai Co., Ltd. and Biogen Inc. announced a presentation about exploring the use of plasma-based biomarkers in the Phase 3 AHEAD 3-45 study of lecanemab (BAN2401), an investigational anti-amyloid beta (Aß) protofibril antibody. AHEAD 3-45 is the first preclinical Alzheimer's disease (AD) trial to use these biomarkers to detect AD pathology and potentially accelerate the screening process. This presentation was made by The Alzheimer's Clinical Trial Consortium (ACTC) at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9, 2021 to November 12, 2021 in Boston, Massachusetts and virtually. The AHEAD 3-45 clinical study will evaluate the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. The Phase 3 AHEAD 3-45 study consists of two sister trials (A3 and A45) with specific dosing regimens tailored to baseline brain amyloid levels on screening PET scans for intermediate amyloid in A3 and for elevated amyloid in A45. In a approach in a preclinical trial for AD, the study will seek to determine the potential role of plasma-based biomarkers in the identification of cognitively unimpaired individuals most appropriate to move on to PET imaging, which is currently the standard of care to determine treatment approach. Blood samples will be collected at a brief initial visit to determine the Aß42/40 ratio, which has previously been shown to be a potentially reliable predictor of brain amyloid level and is used to determine eligibility to proceed to PET imaging. Based on the PET imaging results, the participants are grouped into A3 or A45 trials. As of October 18, 2021, data from 659 participants was available for analysis. Adjusted Aß42/40 ratio demonstrated very good ability to predict amyloid PET eligibility (AUC of 0.87) suggesting plasma screening has potential to substantially reduce number of PET scans needed to fully enroll A3 and A45.

Eisai Co., Ltd. and Biogen Inc. Present New Analysis of Lecanemab Clinical Efficacy Results from Phase 2B Study at Clinical Trials on Alzheimer's Disease Conference

2021-11-11 16:20:00

Eisai Co., Ltd. and Biogen Inc. announced results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD). This presentation was made by Eisai at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer's Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. Six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for ADCOMS, CDR-SB and ADAS-Cog14 at 18 months. The primary endpoint was Bayesian analysis of 12-month clinical change on ADCOMS with the goal to identify the most efficacious dose (ED90 dose). Primary analysis was super-superiority over placebo by =25%: goal was 80% probability of =25% reduction in decline versus placebo. Study achieved the goal of identifying smallest dose that achieved =90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ED90 dose. At 12 months, ED90 dose had 64% probability of being super-superior to placebo by 25% reduction. At 12 months, ED90 dose had 98% probability superior to placebo. Consistent treatment effect was observed at 18 months for ADCOMS (29% to 37%), CDR-SB (26.5% to 35%), and ADAS-Cog (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses.

Eisai Co., Ltd. and Biogen Inc. Presents Late-Breaker Updates on Lecanemab Clinical, Biomarker and Safety Data from Phase 2B Study Core and Open-Label Extension Across Five Years At Clinical Trials on Alzheimer's Disease Conference

2021-11-10 19:57:00

Eisai Co., Ltd. and Biogen Inc. announced results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer's disease (AD) from the lecanemab Phase 2b 201 and the open-label extension (OLE) studies. The findings were presented and discussed in a late-breaking roundtable session with esteemed clinical researchers at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021, in Boston, Massachusetts and virtually. Eisai recently initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (Aß) protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. An OLE with 10 mg/kg IV biweekly lecanemab dosing was implemented after analysis of the 18-month, core phase (Study 201, Alz Res Therapy 13;21) with an intervening off-treatment period (gap period) ranging from 9-59 months (mean 24 months). The OLE phase evaluated the effect of lecanemab on amyloid PET over 12 months of treatment, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). This study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory. The updated assessment of the OLE phase showed that treatment with lecanemab resulted in reduction of brain amyloid levels in as early as 3 months based on OLE data and robust clearance of amyloid plaque with more than 80% of participants (10/12) achieving amyloid negative status by 12-18 months of treatment as measured by PET (visual read). These results are consistent with core phase results. The 201 study core data suggested that clinical efficacy (ADCOMS) is correlated with amyloid reduction (PET SUVr) at both the population (correlation coefficients=0.832, p-value=0.080) and subject levels (correlation coefficients=0.201, slope=0.199, p=0.036). Amyloid PET levels were significantly reduced by quantitative assessment in newly treated OLE subjects in as early as 3 months after initiation of treatment. Additionally, the core data suggested that clinical efficacy is correlated with plasma Aß at both the population (correlation coefficients=-0.306, not significant) and subject levels (correlation coefficients=-0.208, slope=-3.957, p-value=0.050). The clinical treatment difference in study participants between lecanemab treatment and placebo at the end of core period is maintained after discontinued dosing over the 24-month Gap period. The reduction of clinical decline of participants receiving the high dose of lecanemab relative to placebo at the end of the 18-month, core period showed a difference of 0.05 in ADCOMS (placebo 0.19, lecanemab 0.14). This treatment difference of 0.10 in subjects who entered OLE was maintained while off-treatment during the gap period up to the beginning of the OLE (placebo 0.28, lecanemab 0.18). Similar findings were observed for CDR-SB and ADAS-Cog, although both groups continued to progress. This pattern of sustained treatment effect after stopping lecanemab, reflected in biomarkers as well amyloid PET, plasma Aß42/40 and ptau181 is consistent with a disease-modifying effect. New results were presented for two new blood tests that were measured in the Phase 2b and OLE studies: Plasma Aß42/40 ratio and Plasma p-tau181. Plasma Aß42/40 ratio changes suggested an inverse correlation with amyloid PET changes. Both amyloid PET and blood Aß show correlation with ADCOMS at the population and individual levels in the core phase (PET correlation coefficients=0.832 population, 0.201 subject level and Aß plasma correlations coefficients:-0.306 population, -0.208 subject level). Monitoring of treatment effects using plasma biomarkers may allow simple dose modification following robust amyloid removal (e.g., less frequent and/or lower dose). Consistent with the safety findings in the core period, lecanemab was well-tolerated with <10% incidence of ARIA-E at 10 mg/kg biweekly in the Core and OLE. The incidence of symptomatic ARIA-E was <2% in Core and OLE. This safety profile enables lecanemab to be initiated at the therapeutic dose without titration.

ALS One, 4th Annual ALS ONE Research Symposium, Nov 29, 2021 through Nov 30, 2021

2021-11-10 13:00:00

ALS One, 4th Annual ALS ONE Research Symposium, Nov 29, 2021 through Nov 30, 2021.

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022

2021-11-09 17:12:00

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022. Venue: San Diego Convention Center, San Diego, California, United States.

Biogen Inc. - Special Call

2021-11-09 05:04:00

Dose and time dependent changes in plasma ptau181 in patients treated with aducanumab in the ENGAGE and EMERGE trials at CTAD

Biogen Inc. Presents at 2021 Clinical Trials on Alzheimer's Disease, Nov-09-2021 through Nov-12-2021

2021-11-03 11:34:00

Biogen Inc. Presents at 2021 Clinical Trials on Alzheimer's Disease, Nov-09-2021 through Nov-12-2021. Presentation Date(s): Nov-09-2021. Nov-11-2021.

Biogen Announces Late Breakers and Additional New Data Presentations at the 2021 Clinical Trials on Alzheimer’S Disease Meeting

2021-11-03 11:30:00

Biogen Inc. announced the company will present a variety of new data from its Alzheimer’s disease product portfolio and clinical development pipeline at the upcoming annual Clinical Trials on Alzheimer’s Disease conference (CTAD), held November 9-12 virtually and in Boston, Massachusetts. Biogen’s contributions to the conference are driven in part by analyses from the largest clinical trial dataset in early Alzheimer’s disease research. This includes over 3,000 patients in Phase 3 trials and approximately 1,700 patients in the ADUHELM (aducanumab-avwa) redosing trial, EMBARK. A late breaking presentation will highlight important new data from over 7,000 plasma samples from the ADUHELM Phase 3 trials that, for the first time, examines the effect of ADUHELM on plasma phosphorylated tau181 (p-Tau181) and its correlation to amyloid beta plaques and disease progression, as measured by clinical decline endpoints, in patients with early Alzheimer’s disease. The accumulation of amyloid beta plaques and tangles of tau proteins in brain cells are the two defining pathologies of Alzheimer’s disease. The data will be discussed at the virtual oral presentation and roundtable: “Dose and time dependent changes in plasma ptau181 in patients treated with aducanumab in the ENGAGE and EMERGE trials,” on November 11, at 5:10 p.m. EST. Biogen will also present data from over 1,800 patients that were screened for the EMBARK re-dosing trial with ADUHELM, to shed light on the impact of stopping treatment in clinical trials. Patients who were enrolled in the ADUHELM trials when they were discontinued in 2019 later re-enrolled in the EMBARK trial, after a lengthy off-treatment period of an average of 1.7 years. Some of these patients had been on treatment for more than 4 years in the PRIME Phase 1b long-term extension, as well as for up to 18 months in the Phase 3 trials, EMERGE and ENGAGE. Disease progression and amyloid beta plaque levels during this extended discontinuation of Alzheimer’s disease treatment will be examined in the Virtual Oral Presentation, “Baseline EMBARK data from EMERGE, ENGAGE, and PRIME participants in the EMBARK re-dosing study,” on November 9, at 8:00 a.m. EST. In addition, a poster titled, “Urgency to treat before it’s too late: Daily transitions to moderate AD dementia in the US and Europe,” will examine how many people are estimated to progress daily from mild cognitive impairment due to Alzheimer's disease to mild Alzheimer’s disease, and from mild Alzheimer’s disease to moderate Alzheimer's disease, pointing to the urgency for earlier detection, diagnosis and treatment.

Biogen Inc. Presents at TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov-17-2021 09:05 AM

2021-10-30 00:09:00

Biogen Inc. Presents at TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov-17-2021 09:05 AM. Speakers: Chris Chorley, Senior Manager, Regulatory Affairs, Global CMC.

Biogen Inc. Presents at BioData World Congress 2021, Nov-04-2021 02:00 PM

2021-10-28 15:58:00

Biogen Inc. Presents at BioData World Congress 2021, Nov-04-2021 02:00 PM. Speakers: Govinda Bhisetti, Principal Investigator.

Biogen Inc. Presents at BIO-Europe Digital, Oct-27-2021 05:00 PM

2021-10-20 12:14:00

Biogen Inc. Presents at BIO-Europe Digital, Oct-27-2021 05:00 PM. Speakers: Michael M Shih, Head of Business Development.

Biogen Inc. Updates Earnings Guidance for the Full Year of 2021

2021-10-20 11:10:00

Biogen Inc. updated earnings guidance for the full year of 2021. For the year, the company expects total revenue to be $10.8 to $10.9 billion compared to previous guidance of $10.65 to $10.85 billion.

Biogen Inc. Reports Unaudited Impairment Charges for the Three Months Ended September 30, 2021

2021-10-20 11:10:00

Biogen Inc. reported unaudited impairment charges for the three months ended September 30, 2021. For the period, the company reported impairment charges of $44.3 million compared to $19.3 million a year ago.

Tranche Update on Biogen Inc. (NasdaqGS:BIIB)'s Equity Buyback Plan announced on October 21, 2020.

2021-10-20 07:10:00

From July 1, 2021 to September 30, 2021, the company has repurchased 2,199,230 shares, representing 1.48% for $750 million. With this, the company has completed the repurchase of 7,648,931 shares, representing 5.05% for $2,200 million under the buyback announced on October 21, 2020.

Sage Therapeutics, Inc. and Biogen Inc. Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022

2021-10-19 10:30:00

Sage Therapeutics, Inc. and Biogen Inc. announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages. Sage and Biogen also announced the CORAL Study is fully enrolled and closed to further screening, with topline data expected in early 2022. The CORAL Study is designed to demonstrate a rapid onset of depression relief when zuranolone is co-initiated with a standard antidepressant therapy. Sage and Biogen plan to submit a separate and distinct filing for PPD once the ongoing PPD 301-SKYLARK Study completes so as not to affect the MDD review timeline. The companies plan to commence marketing for the approved indications as soon as possible pending the FDA’s approval. The review cycles may allow commercialization of both indications simultaneously, if approved. Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational, or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 19 million people in the U.S. and more than 250 million people worldwide suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile. Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy. PPD can have a serious negative impact on a woman, including significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. PPD is estimated to affect approximately one in eight women who have given birth in the U.S. or approximately over 500,000 women annually. Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration. Zuranolone is being evaluated in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE program includes five studies of zuranolone in patients with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL Studies). The NEST program includes two placebo-controlled studies of zuranolone in patients with PPD (ROBIN and SKYLARK Studies). Additionally, Shionogi recently completed a Phase 2 study of zuranolone in Japan.

Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS

2021-10-17 20:20:00

Biogen Inc. announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). While tofersen did not meet the primary endpoint of change from baseline to week 28 in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), trends favoring tofersen were seen across multiple secondary and exploratory measures of biologic activity and clinical function. In addition, a pre-specified integration of data from VALOR and its ongoing open-label extension study (OLE) reinforced these findings and showed that early tofersen initiation led to less decline across multiple measures of motor function, respiratory function, muscle strength, and quality of life in people with SOD1-ALS. Most adverse events in both VALOR and OLE were mild to moderate in severity, including procedural pain, headache, pain in extremity, fall and back pain. Biogen is actively engaging with regulators, the medical community, patient advocacy groups and other key stakeholders around the world to determine potential next steps. ALS is a progressive neurodegenerative disease that is uniformly fatal with an average survival of three to five years. The most common cause of death is respiratory failure. SOD1-ALS is a rare, genetic form of ALS that accounts for approximately two percent of the estimated 168,000 people who have the disease globally. Currently, there are no genetically targeted treatment options for ALS.

Biogen Inc. Presents at The Annual Meeting of the American Neurological Association, Oct-17-2021 04:20 PM

2021-10-14 20:06:00

Biogen Inc. Presents at The Annual Meeting of the American Neurological Association, Oct-17-2021 04:20 PM. Speakers: Timothy Miller, principal investigator of VALOR and ALS Center Director at Washington.

Biogen Inc. Announces Topline Results from Tofersen Phase 3 Study and Its Open Label Extension in Sod1-Als to Be Presented At the American Neurological Association Annual Meeting

2021-10-14 20:06:00

Biogen Inc. announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense oligonucleotide (ASO) drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), will be presented at the upcoming American Neurological Association (ANA) 2021 virtual meeting, October 17-19, 2021.

Biogen Inc. Presents at HLTH 2021 Conference, Oct-19-2021 01:25 PM

2021-10-14 16:17:00

Biogen Inc. Presents at HLTH 2021 Conference, Oct-19-2021 01:25 PM. Venue: Boston, Massachusetts, United States. Speakers: Sally John, VP of Translational Science.

Biogen Inc. Announces New Data from its Industry-Leading Portfolio of Multiple Sclerosis (MS) Therapies

2021-10-13 10:05:00

Biogen Inc. announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies. These data include additional results from the NOVA study on the efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV) administration, results from a comparative real-world evaluation of TYSABRI® (natalizumab) when compared to Ocrevus®(ocrelizumab), as well as outcomes on GI tolerability, persistence and adherence for VUMERITY® (diroximel fumarate). The studies are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021. New late-breaking data from the Phase 3b NOVA study provide additional insights into the efficacy of every six-week (Q6W) 300mg natalizumab IV administration compared to the approved every four-week (Q4W) dose of TYSABRI (n=499) for relapsing-remitting multiple sclerosis. Topline results from the NOVA study were released in August 2021, showing that every six-week administration provides a high level of efficacy in controlling MS disease activity in patients who switched to Q6W after at least one year of disease stability on the approved Q4W IV dosing schedule. New results of exploratory outcomes and additional secondary endpoints presented at ECTRIMS demonstrate that efficacy is maintained on a Q6W schedule: Time to first relapse was similar between the two dosing schedules with the proportion who were relapse-free at 72 weeks at 96.9% for Q6W and 97.6% for Q4W; The proportion of patients free of disability worsening was 90.0% in the Q6W arm and 92.0% in the Q4W arm; Disease activity rates were similar between both groups. The proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0% for Q6W and 67.4% for Q4W. NEDA was defined as no gadolinium enhancing (Gd+) lesions, no new or newly enlarging T2 hyperintense lesions, no relapse and no 24-week confirmed disability worsening (CDW) at 72 weeks. Patients with one or more missing assessments were counted as having not achieved NEDA; The safety findings in the NOVA study were consistent with the known safety profile of IV natalizumab, and the incidence of AEs and SAEs were similar between the two treatment arms. One patient with asymptomatic progressive multifocal leukoencephalopathy (PML) in the Q6W arm was high-risk based on the known risk factors, underscoring the importance of the need for continued PML monitoring and risk factor considerations in patients treated with natalizumab. The NOVA study was designed to assess the efficacy of Q6W dosing with natalizumab IV administration following analyses from the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program, which showed that extended interval dosing was associated with a significant reduction in the probability of PML.4 Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen.

Informa plc, TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov 15, 2021 through Nov 17, 2021

2021-10-12 20:23:00

Informa plc, TIDES EUROPE: Oligonucleotide & Peptide Therapeutics, Nov 15, 2021 through Nov 17, 2021.

Biogen Inc. Presents at 5th Annual Gene Therapy for Rare Disorders Europe Conference, Nov-03-2021

2021-10-12 17:48:00

Biogen Inc. Presents at 5th Annual Gene Therapy for Rare Disorders Europe Conference, Nov-03-2021 . Speakers: Xiaotong Fu, Senior Engineer.

Hanson Wade Limited, 5th Annual Gene Therapy for Rare Disorders Europe Conference, Nov 03, 2021 through Nov 04, 2021

2021-10-12 06:24:00

Hanson Wade Limited, 5th Annual Gene Therapy for Rare Disorders Europe Conference, Nov 03, 2021 through Nov 04, 2021.

HLTH, LLC, HLTH 2021 Conference, Oct 17, 2021 through Oct 20, 2021

2021-10-08 12:30:00

HLTH, LLC, HLTH 2021 Conference, Oct 17, 2021 through Oct 20, 2021. Venue: Boston, Massachusetts, United States.

Biogen Inc., Q3 2021 Earnings Call, Oct 20, 2021

2021-10-06 21:53:00

Biogen Inc., Q3 2021 Earnings Call, Oct 20, 2021

Biogen Inc. to Report Q3, 2021 Results on Oct 20, 2021

2021-10-06 21:53:00

Biogen Inc. announced that they will report Q3, 2021 results Pre-Market on Oct 20, 2021

Biogen Inc. Presents at DIA: Digital Technology in Clinical Trials conference, Oct-27-2021

2021-10-06 16:45:00

Biogen Inc. Presents at DIA: Digital Technology in Clinical Trials conference, Oct-27-2021 . Speakers: Josh Cosman, Associate Director, Digital and Quantitative Medicine, Lauren Oliva, Global Regulatory Policy Lead, New Technologies.

Drug Information Association, Inc., DIA: Digital Technology in Clinical Trials conference, Oct 27, 2021 through Oct 29, 2021

2021-10-06 12:29:00

Drug Information Association, Inc., DIA: Digital Technology in Clinical Trials conference, Oct 27, 2021 through Oct 29, 2021.

Terrapinn Holdings Ltd, BioData World Congress 2021, Nov 02, 2021 through Nov 04, 2021

2021-10-06 12:29:00

Terrapinn Holdings Ltd, BioData World Congress 2021, Nov 02, 2021 through Nov 04, 2021.

Sage Therapeutics and Biogen Announces Consistent Clinically Meaningful Data for Zuranolone Across the Landscape and Nest Clinical Development Programs Presented At the European College of Neuropsychopharmacology (Ecnp) Congress

2021-10-04 10:30:00

Sage Therapeutics, Inc. and Biogen Inc. announced new data from the LANDSCAPE and NEST clinical development programs evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD) presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 2-5, 2021. Presentations include data from the WATERFALL Study, a Phase 3 placebo-controlled trial evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years old with MDD as well as the open-label SHORELINE Study in MDD and cross-study analyses from across the LANDSCAPE and NEST programs. Collectively, the studies show reductions in depressive symptoms with zuranolone-treated patients such as consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3. Zuranolone has demonstrated a consistent safety profile in the totality of clinical data to date, with no evidence of withdrawal, weight gain, sexual dysfunction, euphoria, or sleep disruption; symptoms that are typically the cause of treatment discontinuation with current standard of care antidepressants. In pooled analyses from the LANDSCAPE and NEST programs of SF-36v2, a patient self-reported measure of general health, zuranolone treatment led to rapid improvement in quality of life and overall health across all functioning and well-being domains at Day 15 and across all domains at Day 42 (Day 45 in ROBIN Study). Additional data presented summarized clinical data from the literature on onset of effect of current treatment options in MDD demonstrating there is a need for new treatment options with the potential for rapid response. The Short Form health survey (SF-36) is an often-used, well-researched, and self-reported measure of general health. The SF-36 uses 36 questions, covering eight domains of health, to assess the general health status and quality of life at the individual level in clinical practice and research, and at the population level for health policy evaluations. The SF-36 has been used in thousands of research studies, and while it was originally designed as a generic health measure, it is also applied to specific disease populations. The SF-36 represents an international benchmark for health outcomes measurement and has been used as efficacy endpoints in clinical trials. Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration. Zuranolone is being evaluated as a potential rapid-acting treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE program includes five studies of zuranolone in patients with MDD. Data have been reported from three studies of zuranolone 30 mg in patients with MDD (MDD-201B, MOUNTAIN Study and the 30 mg cohort from the ongoing SHORELINE Study), and one study of zuranolone 50 mg in patients with MDD (WATERFALL Study) in addition to an interim cut of the zuranolone 50mg cohort of the ongoing SHORELINE Study. Two additional studies evaluating zuranolone 50 mg in patients with MDD are expected to read out by the end of 2021 (CORAL Study and another cut of the 50mg cohort of the SHORELINE Study). The NEST Program includes two placebo-controlled studies of zuranolone in patients with PPD. Positive data from the ROBIN Study (zuranolone 30 mg) have been previously reported. The SKYLARK Study (zuranolone 50 mg) is anticipated to readout by mid-2022. The programs are designed to generate data to support a potential NDA filing as efficiently as possible. If successful, LANDSCAPE and NEST may support paths to approval with three distinct opportunities to address patient needs: PPD, acute rapid response therapy in MDD when co-initiated with a new standard antidepressant, and as-needed treatment of MDD.

Biogen Inc. Presents at BioFuture, Oct-05-2021 01:30 PM

2021-09-30 19:39:00

Biogen Inc. Presents at BioFuture, Oct-05-2021 01:30 PM. Venue: The Lotte Palace Hotel, New York City, New York, United States. Speakers: Georgia Mitsi, GM Mental Health & VR solutions.

Biogen Inc. Presents at B &T Cell-Mediated Autoimmune Disease Drug Development Summit, Oct-07-2021 11:20 AM

2021-09-29 15:45:00

Biogen Inc. Presents at B &T Cell-Mediated Autoimmune Disease Drug Development Summit, Oct-07-2021 11:20 AM. Speakers: Michael Mingueneau, Director, Research, Michael Palte, Associate Medical Director, Clinical Development.

Hanson Wade Limited, B &T Cell-Mediated Autoimmune Disease Drug Development Summit, Oct 06, 2021 through Oct 07, 2021

2021-09-29 13:51:00

Hanson Wade Limited, B &T Cell-Mediated Autoimmune Disease Drug Development Summit, Oct 06, 2021 through Oct 07, 2021.

CTAD, 2021 Clinical Trials on Alzheimer's Disease, Nov 09, 2021 through Nov 12, 2021

2021-09-29 12:09:00

CTAD, 2021 Clinical Trials on Alzheimer's Disease, Nov 09, 2021 through Nov 12, 2021.

Biogen Inc. Presents at Longwood Healthcare Leaders Conference, Oct-04-2021 through Oct-05-2021

2021-09-28 18:44:00

Biogen Inc. Presents at Longwood Healthcare Leaders Conference, Oct-04-2021 through Oct-05-2021. Presentation Date & Speakers: Oct-04-2021, Alfred W. Sandrock, Executive Vice President of Research & Development, Diana Gallagher, Head, External Innovation & New Indications. Oct-05-2021, Anabella Villalobos, Senior Vice President of Biotherapeutic & Medicinal Sciences, Phil Sharp, Co-Founder.

Biogen Inc. Presents at Transparency & Aggregate Spend, Dec-06-2021

2021-09-28 14:33:00

Biogen Inc. Presents at Transparency & Aggregate Spend, Dec-06-2021 . Venue: Hilton Philadelphia at Penn's Landing, Philadelphia, Pennsylvania, United States. Speakers: Jennifer Parsons, Director, U.S. Transparency and Compliance Operations.

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021

2021-09-28 13:09:00

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021.

Informa plc, Transparency & Aggregate Spend, Dec 06, 2021 through Dec 10, 2021

2021-09-27 17:31:00

Informa plc, Transparency & Aggregate Spend, Dec 06, 2021 through Dec 10, 2021. Venue: Hilton Philadelphia at Penn's Landing, Philadelphia, Pennsylvania, United States.

American Neurological Association, the Annual Meeting of the American Neurological Association, Oct 17, 2021 through Oct 19, 2021

2021-09-23 16:45:00

American Neurological Association, The Annual Meeting of the American Neurological Association, Oct 17, 2021 through Oct 19, 2021.

Cambridge Healthtech Institute, Inc., SCOPE Summit for Clinical Ops Executives, Feb 07, 2022 through Feb 10, 2022

2021-09-21 18:42:00

Cambridge Healthtech Institute, Inc., SCOPE Summit for Clinical Ops Executives, Feb 07, 2022 through Feb 10, 2022. Venue: Rosen Shingle Creek, Orlando, Florida, United States.

Biogen Inc. Presents at SCOPE Summit for Clinical Ops Executives, Feb-07-2022

2021-09-21 18:42:00

Biogen Inc. Presents at SCOPE Summit for Clinical Ops Executives, Feb-07-2022 . Venue: Rosen Shingle Creek, Orlando, Florida, United States. Speakers: Adam L. Sheriff, Senior Director, Clinical Drug Supply, Imran M. Shakur, Associate Director, Clinical Supply Capabilities.

FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ (SB11), LUCENTIS Biosimilar (ranibizumab-nuna)

2021-09-20 11:30:00

Samsung Bioepis Co. Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the United States (U.S.). BYOOVIZ™ is the first ophthalmology biosimilar approved in the United States. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer cost savings and promote sustainable access to therapies. Savings in the United States over the next five years from 2020 to 2024 as a result of biosimilars are projected to exceed $100 billion. In addition to the U.S. approval, BYOOVIZ™ was approved in Europe, including 27 European Union (EU) member countries on August 18, 2021 and the United Kingdom on August 31, 2021. The FDA approval of BYOOVIZ™ was based on a totality of evidence including analytical, non-clinical data, and clinical data. In a randomized, double-masked, parallel group, multicenter Phase 3 study of SB11, the efficacy, safety, pharmacokinetics, and immunogenicity of SB11 was compared to reference ranibizumab in patients with wet AMD. 705 patients were randomized (1:1) to receive SB11 or reference ranibizumab in monthly injections (0.5 mg), and 634 patients continued to receive treatment up to week 48.The Least Squares (LS) mean change in best corrected visual acuity (BCVA) from baseline at week 52 was 9.79 letters for SB11, compared with 10.41 letters for reference ranibizumab (difference: -0.62, [90% CI: -2.092, 0.857]). The LS mean change in central subfield thickness (CST) was -139.55 µm for SB11 vs -124.46 µm for reference ranibizumab (difference: -15.09, [95% CI, -25.617, -4.563]). PK, safety including incidence of treatment-emergent adverse events, and the immunogenicity profile of SB11 and reference ranibizumab were comparable at all timepoints up to week 52.

Biogen Inc. Receives Approval from European Medicines Agency for VUMERITY in the European Union as A Treatment for Relapsing-Remitting Multiple Sclerosis

2021-09-17 13:09:00

Biogen Inc. announced that the Committee for Medicinal Products for Human Use, part of the European Medicines Agency, issued a positive opinion and has recommended granting marketing authorization for VUMERITY (diroximel fumarate) in the European Union. VUMERITY is a next-generation oral fumarate for the treatment of adults with relapsing-remitting multiple sclerosis. An estimated 2.8 million people live with MS across the globe, with some European countries demonstrating the highest prevalence of MS in the world. The CHMP’s positive opinion will now be referred to the European Commission, which grants marketing authorizations for medicines in Europe. The positive CHMP opinion was based on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied in part on the well-established long-term safety and efficacy profile of TECFIDERA. The CHMP also assessed findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center Phase 3 study to evaluate the gastrointestinal tolerability of VUMERITY compared to TECFIDERA in patients with RRMS. In EVOLVE-MS-2, the rate of overall treatment discontinuation was lower in participants treated with VUMERITY compared to those treated with TECFIDERA. The difference in the discontinuation rates due to GI tolerability was 0.8% for VUMERITY compared to 4.8% for TECFIDERA. VUMERITY was first approved by the U.S. Food and Drug Administration in October 2019 and is currently the number one prescribed oral MS therapy in the country. Since its launch in the U.S., real-world data have reinforced the positive GI tolerability profile of VUMERITY and confirmed that the experience demonstrated in clinical trials is consistent with clinical practice. Biogen continues to file regulatory submissions in other countries. VUMERITY is an oral fumarate with a distinct chemical structure from TECFIDERA, approved in the U.S. for the treatment of relapsing forms of multiple sclerosis in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate providing similar efficacy and safety profiles. VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and inatients taking dimethyl fumarate. Serious side effects for VUMERITY are based on data from dimethyl fumarate and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which is a rare opportunistic viral infection of the brain that has been associated with death or severe disability, a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. The most common adverse events, obtained using data from dimethyl fumarate, were flushing, abdominal pain, diarrhea and nausea. TECFIDERA, a treatment for relapsing forms of multiple sclerosis in adults, is the most prescribed oral medication for relapsing MS in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS. TECFIDERA is approved in 69 countries, and more than 500,000 patients have been treated with it, representing more than 1,000,000 patient-years of exposure across clinical trial use and patients prescribed TECFIDERA. Of these, 6,335 patients were from clinical trials.

Biogen Inc. - Pre Recorded Special Call

2021-09-16 14:26:00

Biogen Inc. - Pre Recorded Special Call

Biobiogen Inc. Announces Positive Topline Results from Phase 2 Convey Study in Small Fiber Neuropathy

2021-09-16 11:30:00

Biogen Inc. announced positive topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074), a non-opioid investigational oral pain drug being evaluated for the treatment of small fiber neuropathy (SFN). The CONVEY study 200 mg twice daily arm met its primary endpoint of change from baseline to week 12 of the double-blind period in mean average daily pain (ADP) score. In this study, all participants who enrolled received the higher dose (350 mg twice daily) in an open-label portion which preceded the double-blind portion of the study. While the 350 mg twice daily arm did not meet the primary endpoint, it met statistical significance in the Patient Global Impression of Change (PGIC) at week 12, an important self-reported measure of a patient’s overall improvement since with the start of the study. The totality of data from the vixotrigine program will inform potential doses for study in future Phase 3 clinical trials. There is a significant unmet need for non-opioid treatments for people suffering from chronic neuropathic pain. Small fiber neuropathy is often characterized by severe pain that typically begins in the feet or hands. Painful symptoms are described as burning, shooting and/or prickling. Pain can be caused by stimuli that does not normally provoke pain (allodynia) and potentially painful stimuli are increased in intensity (hyperalgesia). Symptoms tend to be worse at night and during periods of rest and can lead to a significant impact on overall quality of life. CONVEY Topline Study Results: CONVEY was a Phase 2 placebo-controlled, double-blind, enriched enrollment, randomized withdrawal study that evaluated the efficacy and safety of vixotrigine in treating pain experienced by participants with confirmed idiopathic or diabetes mellitus-associated small fiber neuropathy. Statistical testing to compare each vixotrigine dose with placebo was pre-defined at the 10% significance level without multiplicity adjustment. Vixotrigine 200 mg twice daily resulted in a statistically significant reduction in the mean average daily pain (ADP) score versus placebo at week 12 (p=0.0501). Treatment effect was noted in participants with diabetes mellitus based on a subgroup analysis but was not evident in the smaller subgroup of patients with idiopathic SFN. The 200 mg dose also resulted in statistically significant improvement versus placebo on the mean worst daily pain score at week 12 (p=0.0455). Numeric advantage of 200 mg over placebo was observed in additional secondary endpoints, including the proportion of participants with a 2-point or greater improvement in the average daily pain score and the proportion of participants with =30% reduction in ADP at week 12, but these did not meet statistical significance. Vixotrigine 350 mg twice daily did not meet the primary endpoint of mean change in ADP at week 12. However, treatment with 350 mg vixotrigine resulted in a statistically significant increase in the proportion of participants who reported they were “very much improved” or “much improved” when compared to baseline, using the Patient Global Impression of Change (PGIC) questionnaire (p=0.0580). In addition, numeric advantage of 350 mg over placebo was observed in some secondary endpoints, including the proportion of participants with a 2-point or greater improvement in the average daily pain score and the proportion of participants with =30% reduction in ADP at week 12, but these did not meet statistical significance. Both doses of vixotrigine were generally well tolerated and the safety profile was consistent with previous studies of vixotrigine with no evidence of abuse potential. In the open-label period, common AEs (incidence = 2.5%) were dizziness, headache, vertigo, and nausea. 5.3% of subjects discontinued the open-label part of the study due to adverse events; across the entire study the majority of the AEs were mild or moderate in severity. Biogen will further evaluate the CONVEY data and plans to complete a Phase 1 clinical study to inform potential next steps in the development of vixotrigine. In addition, detailed results from the CONVEY study will be made available in a future scientific forum.

Biogen Inc Announces Plans to Initiate Global Phase 3B Clinical Study, ASCEND

2021-09-15 11:30:00

Biogen Inc. announced plans to initiate a global Phase 3b clinical study, ASCEND. The ASCEND study is designed to evaluate the clinical outcomes and assess the safety of a higher dose of nusinersen in children, teens and adults with later-onset spinal muscular atrophy (SMA) following treatment with Evrysdi® (risdiplam). People with SMA do not produce enough survival motor neuron (SMN) protein, which is critical for the ongoing maintenance of motor neurons that support sitting, standing and movement. Over time, people with SMA may lose their ability to perform everyday activities, including brushing their teeth, turning on a light switch or drinking from a cup. The goal of treatment in SMA is to sufficiently protect motor neurons and help preserve function. Available data suggest that exposure to Evrysdi diminishes with increased age and weight, with an approximately 40% reduction in drug concentration in adults compared to infants. Evrysdi’s dosing is capped at 5 milligrams (mg) once patients reach 20 kilograms (kg).8 At the approved 12-mg dose, motor neuron exposure to nusinersen remains similar as patients age and grow. Further, nusinersen has demonstrated proven, sustained efficacy and a well-characterized safety profile, with long-term data in patients treated for more than 7 years across ages and SMA types. Taken together, these data support further exploration of whether a higher dose can deliver even greater efficacy to patients. The ASCEND study will assess if nusinersen at a higher dose may address outstanding clinical needs among later-onset SMA patients treated with Evrysdi who want to make a change in their treatment regimen. The same investigational higher dose of nusinersen is also being evaluated in the ongoing DEVOTE study. The ASCEND protocol has been submitted to the U.S. Food and Drug Administration and is planned to be an approximately 2.5-year study projected to enroll up to 135 later-onset, non-ambulatory individuals with SMA (aged 5 to 39). All participants must have been previously treated with Evrysdi at the maximum recommended dose of 5 mg and be willing and able to change their treatment regimen to a higher dose of nusinersen. Participants must also fall within a particular Revised Upper Limb Module (RULM) measurement range to enter the study. Individuals enrolled in ASCEND will receive two loading doses of nusinersen 50 mg two weeks apart, followed by a maintenance dose of 28 mg every four months during the study period. Efficacy is planned to be assessed by RULM. Additional clinical outcomes include safety, Hammersmith Functional Motor Scale Expanded (HFMSE) and caregiver burden. The study will also evaluate upper limb fine motor function in participants aged 13 and older using the mobile application Konectom™, and neurofilament levels as a marker of biological disease activity, both exploratory endpoints. The study aims to include children, teens and adults naïve to treatment with nusinersen, as well as adults who were previously treated with nusinersen prior to Evrysdi. The company aims for the first eligible patients to be enrolled in 2021.

Biogen Inc. Presents at BioProcess International Conference & Exhibition, Sep-20-2021

2021-09-08 22:27:00

Biogen Inc. Presents at BioProcess International Conference & Exhibition, Sep-20-2021 . Speakers: Xiaotong Fu, Sr. Engineer.

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021

2021-09-08 21:27:00

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021.

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022

2021-09-04 12:00:00

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022. Venue: Orlanda, Florida, United States.

Biogen Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-09-2021 09:30 AM

2021-09-01 20:31:00

Biogen Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-09-2021 09:30 AM. Venue: New Windsor, United States.

Biogen Inc. Presents at World Orphan Drug Congress USA 2021, Aug-25-2021 through Aug-27-2021

2021-08-20 20:21:00

Biogen Inc. Presents at World Orphan Drug Congress USA 2021, Aug-25-2021 through Aug-27-2021. Venue: Gaylord National Resort & Convention Center, Oxon Hill, Maryland, United States. Presentation Date & Speakers: Aug-25-2021, Lili Peng, Associate Director, External Innovation Data Sciences. Aug-26-2021, Lili Peng, Associate Director, External Innovation Data Sciences. Aug-27-2021, Mike Mcbrierty, Director, State Public Policy and Government Affairs.

Biogen Inc. Presents at INCLUSION Diversity, Equity and Inclusion Summit, Sep-21-2021 01:00 PM

2021-08-20 19:06:00

Biogen Inc. Presents at INCLUSION Diversity, Equity and Inclusion Summit, Sep-21-2021 01:00 PM. Speakers: Giselle Perez, Head, Global Workforce Diversity and People Relations.

I.I.R Ltd., INCLUSION Diversity, Equity and Inclusion Summit, Sep 21, 2021

2021-08-20 18:44:00

I.I.R Ltd., INCLUSION Diversity, Equity and Inclusion Summit, Sep 21, 2021.

Terrapinn Holdings Ltd, World Orphan Drug Congress USA 2021, Aug 25, 2021 through Aug 27, 2021

2021-08-20 17:31:00

Terrapinn Holdings Ltd, World Orphan Drug Congress USA 2021, Aug 25, 2021 through Aug 27, 2021. Venue: Gaylord National Resort & Convention Center, Oxon Hill, Maryland, United States.

Biogen Inc. Presents at Pharma Europe, Oct-19-2021 10:15 AM

2021-08-05 08:20:00

Biogen Inc. Presents at Pharma Europe, Oct-19-2021 10:15 AM. Speakers: Sarah Clark, Global Head, Medical Affairs and Operations, Digital Health.

Reuters Events, Pharma Europe, Oct 11, 2021 through Oct 22, 2021

2021-08-05 03:58:00

Reuters Events, Pharma Europe, Oct 11, 2021 through Oct 22, 2021.

Biogen Inc. Announces Results from Phase 3b NOVA Study Evaluating Every Six-Week Dosing with Natalizumab in Relapsing-Remitting Multiple Sclerosis

2021-08-02 11:30:00

Biogen Inc. announced results from the two-year prospective, randomized, interventional, controlled, open-label Phase 3b NOVA study (NCT03689972). NOVA was designed to estimate a potential difference between the efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV) administration compared to the efficacy of the approved every four-week (Q4W) dose in people treated with TYSABRI® (natalizumab) (n=499) for relapsing-remitting multiple sclerosis (MS) after at least one year of disease stability on a Q4W IV dosing schedule. The primary endpoint showed a numerical difference between the mean number of new or newly enlarging T2 hyperintense lesions at week 72 of 0.05 (Q4W) and 0.20 (Q6W) (p=0.0755), which based on the full trial results is not clinically meaningful. The numerical difference was driven by a high number of lesions occurring in two participants in the Q6W arm – one patient who developed lesions three months after treatment discontinuation and a second patient who developed asymptomatic progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. The proportion of patients that developed new or newly enlarging T2 lesions in each arm was 4.1% (Q4W) and 4.3% (Q6W). There were no statistically significant or clinically meaningful differences in secondary endpoints at week 72 between the Q4W and Q6W treatment arms, and disease activity was well-controlled in both arms: Annualized relapse rates were low at 0.00010 (Q4W) and 0.00013 (Q6W), with 97.9% patients in the Q4W arm remaining relapse-free compared to 97.2% of patients in the Q6W arm. The proportion of patients that developed T1 hypointense lesions in each arm was 1.1% (Q4W) and 1.4% (Q6W). Both arms demonstrated 0.5% of participants with gadolinium (Gd) enhancing T1 lesions. The NOVA study was initiated to assess the efficacy of Q6W dosing with natalizumab IV administration following analyses from the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program, which showed that extended interval dosing was associated with a significant reduction in the probability of PML. An updated analysis of data from TOUCH showed that an average Q6W dosing regimen is associated with an 88% reduction (hazard ratio 0.118, p<0.0001) in the probability of PML in comparison to the approved Q4W dose. The safety findings in the NOVA study were consistent with the known safety profile of IV natalizumab and the incidence of adverse events and serious adverse events were similar between the two treatment arms. One patient with asymptomatic PML in the Q6W arm was high-risk based on the known risk factors (anti-JCV antibody index >1.5, and >2 years of TYSABRI treatment), underlying the importance of PML monitoring and risk factor considerations in patients treated with natalizumab. A complete analysis of the study data is ongoing and detailed results will be shared in a future scientific forum. Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen. TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. In the U.S., TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS. In the European Union, it is indicated as a single disease modifying treatment (DMT) in adults with highly active relapsing-remitting MS (RRMS) for patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT or patients with rapidly evolving severe RRMS. TYSABRI is approved in over 80 countries, and approximately 220,000 people worldwide have been treated with TYSABRI, with over 880,000 patient-years of experience, based on clinical trials and prescription data. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JCV antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the higher risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), and infections including opportunistic infections, and a reduction in blood platelet counts.

Biotechnology Innovation Organization, EBD GmbH, BIO-Europe Digital, Oct 25, 2021 through Oct 29, 2021

2021-07-30 16:19:00

Biotechnology Innovation Organization, EBD GmbH, BIO-Europe Digital, Oct 25, 2021 through Oct 29, 2021.

Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021

2021-07-29 20:10:00

Biogen and Eisai Co., Ltd. announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer’s disease called ICARE AD-US, at the Alzheimer’s Association International Conference (AAIC), being held both virtually and in Denver, Colo. from July 26 – 30, 2021. ICARE AD-US, a prospective study of ADUHELM™ (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM. The virtual oral session (#57522) was titled, ICARE AD-US: design of a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in United States. ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). ICARE AD-US is a real-world study that will provide information on the long-term effectiveness and safety of ADUHELM as prescribed in routine clinical practice in the U.S. based on the label approved by the U.S. Food and Drug Administration (FDA). The primary objective of the study is to characterize and evaluate real-world, long-term changes in cognition, function and neuropsychiatric status in ADUHELM-treated patients. Secondary objectives are related to gaining a better understanding of ADUHELM safety in real-world clinical practice. The study design includes an important goal to help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer’s disease studies, aiming to enroll at least 16% of the trial’s expected 6,000 participants from these communities. Alzheimer’s disease clinical trials commonly have 1% to 2% enrollment from these groups, even though Black/African Americans and Latinx people are respectively two and one-and-a-half times more likely than older White Americans to have Alzheimer’s disease. The study intends to enroll patients with Alzheimer’s disease over four years from approximately 200 sites in the U.S. Patients will be monitored for a period of up to five years.

Biogen Inc. Presents at Cell & Gene Meeting on the Mesa, Oct-13-2021 09:15 AM

2021-07-29 02:31:00

Biogen Inc. Presents at Cell & Gene Meeting on the Mesa, Oct-13-2021 09:15 AM. Venue: Carlsbad, California, United States. Speakers: Emma McBurney, Vice President, Business Development, Junghae Suh, VP, Head of Gene Therapy Accelerator Unit.

Biogen Inc. and Ionis Pharmaceuticals, Inc. Announces Positive Topline Clinical Data on Investigational Alzheimer's Disease Treatment at AAIC

2021-07-26 20:35:00

Biogen Inc. and Ionis Pharmaceuticals, Inc. announced that topline data from a Phase 1b placebo-controlled, multiple ascending dose clinical study showed that BIIB080/IONIS-MAPTRx met its primary objective of safety and tolerability in patients with mild Alzheimer's disease. The study demonstrated robust time and dose dependent lowering of tau protein in cerebrospinal fluid (CSF) over the three-month treatment period and sustained reductions during the six-month post-treatment period. In patients receiving BIIB080, there were dose-dependent decreases in the concentration of total-tau in CSF eight weeks post-last dose (Day 141) with a mean percentage reduction of 30 percent, 40 percent and 49 percent in the low, medium and high dose groups treated every four-weeks, respectively, and 42 percent in the group treated every 12 weeks. Total-tau in the CSF continued to decline 16 weeks post-last dose in patients treated with BIIB080 in the high dose four-week and 12-week dose groups, showing a 55 percent and 49 percent mean reduction from baseline, respectively. CSF was not collected 16 weeks post-last dose in the low and medium four-week dose groups. There were similar dose-dependent decreases in the levels of phosphorylated tau. All participants (n=46) completed the Multiple Ascending Dose (MAD) period and 43 participants completed the Post-Treatment (PT) period (3 participants voluntarily withdrew). These data were presented in a poster session at the 2021 Alzheimer's Association International Conference (AAIC) held virtually and in Denver, Colo., July 26 – 30. Alzheimer's disease is a progressive neurodegenerative disorder characterized by cognitive and functional decline resulting in significant disability. Until recently, treatment was limited to management of symptoms. BIIB080 is an investigational antisense therapy designed to target microtubule-associated protein tau (MAPT) mRNA and prevent production of tau protein. Growing evidence suggests that aggregated, hype phosphorylated tau may be a key driver of neurodegeneration in Alzheimer's disease as well as other tauopathies including progressive supranuclear palsy and frontotemporal degeneration. In preclinical studies in MAPT transgenic mice, MAPT-targeted antisense treatment demonstrated robust tau-lowering in CNS tissues and prevention and reversal of disease. The primary objective of the Phase 1b first-in-human study was to assess safety and tolerability of multiple intrathecal (IT) bolus administrations of BIIB080. The study was divided into two parts: Part 1, a MAD study of 46 patients with mild Alzheimer's disease comprising a three-month Treatment Evaluation Period and a six-month PT period; Part 2, an open label long-term extension study comprising a 12-month Treatment Evaluation Period and a four- or six-month PT period. Four ascending dose cohorts were enrolled sequentially and randomized 3:1 to IT bolus administrations of BIIB080 or placebo. Patients aged 50-74 years with mild Alzheimer's disease and confirmed amyloid positivity (via CSF) at screening were considered eligible. Part 1 is now complete; Part 2 is currently ongoing (EudraCT: 2016-002713-22; NCT03186989). The characteristics of patients at baseline were representative of relatively younger, mild Alzheimer's disease patients and were generally similar across trial groups. All adverse events were mild to moderate in severity with no serious adverse events occurring in any patients that received BIIB080. There were no deaths, dose-limiting adverse events or dosing discontinuations.

Biogen Inc. Presents at Alzheimer's Association International Conference, Jul-26-2021

2021-07-26 20:10:00

Biogen Inc. Presents at Alzheimer's Association International Conference, Jul-26-2021 . Venue: Denver, Colorado, United States.

Biogen Inc. Revises Earnings Guidance for the Year 2021

2021-07-22 11:09:00

Biogen Inc. revised earnings guidance for the year 2021. For the year, the company revised total revenue of $10.45 billion to $10.75 billion to $10.65 billion to $10.85 billion.

Biogen Inc. Reports Impairment Charges for the Three Months Ended June 30, 2021

2021-07-22 11:09:00

Biogen Inc. reported impairment charges for the three months ended June 30, 2021. For the period, the company reported impairment charges of $541.6 million.

Biogen Inc. Announces Aduhelm Became the First Approved Treatment to Address A Defining Pathology of Alzheimer’s Disease

2021-07-22 11:05:00

Biogen Inc. ADUHELM became the first approved treatment to address a defining pathology of Alzheimer’s disease: targeting the reduction of amyloid plaques in the brain. The company believe patients, family members and physicians deserve the facts about the therapy and the process by which it was approved so they may make informed decisions. The approval of ADUHELM by the U.S. Food and Drug Administration (FDA) came after an extensive development, testing and review process. Over more than a decade, the company at Biogen engaged in rigorous and science-driven research and development that assessed whether ADUHELM could help patients worldwide who suffer from Alzheimer’s disease. The company are proud of the work our dedicated team has done to develop ADUHELM, and of the potential it brings to Alzheimer’s patients. The company are equally proud of the professionalism both our team and the FDA demonstrated during a thorough review process. Unfortunately, ADUHELM’s approval has been the subject of extensive misinformation and misunderstanding. It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data. That is how science advances and we welcome these discussions. Recently, however, there has been a turn outside the boundaries of legitimate scientific deliberation. More than 250 drugs have been granted Accelerated Approval by the FDA: The FDA instituted its Accelerated Approval Program in 1992 to allow for earlier approval of drugs that treat serious conditions, and to fill an unmet medical need based on a surrogate endpoint that is reasonably likely to predict a clinical outcome. Since 1992, 253 accelerated approvals have been granted to drugs to treat HIV/AIDS, sickle cell anemia, Duchenne muscular dystrophy (DMD), multiple sclerosis (MS) and particularly in the oncology therapeutic area. In oncology, for example, the surrogate may be tumor shrinkage, as this is likely to predict increased survival. Many cancer patients have benefitted from novel immunotherapy treatments that have received accelerated approval, and death rates from cancer have declined dramatically. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in the rate of clinical decline. Several people have stated that all previously studied anti-amyloid antibodies clear amyloid from the brain but have failed as a class to demonstrate benefit. This is factually incorrect. First generation anti-amyloid antibodies were not specific for aggregated forms of amyloid beta, or targeted soluble monomeric amyloid beta, or were deficient in effector function. As a result, these antibodies do not clear amyloid from the brain. As such, there is no basis for using the failure of these antibodies as a reason to question the approval of ADUHELM. The review process that led to accelerated approval was extensive and thorough, during which the company responded to numerous questions and requests from the FDA. The approval is supported by data of more than 3,000 patients and 2.2 million pages of clinical data and analyses.

Tranche Update on Biogen Inc. (NasdaqGS:BIIB)'s Equity Buyback Plan announced on October 21, 2020.

2021-07-22 07:09:00

From April 1, 2021 to June 30, 2021, the company has repurchased 1,620,858 shares, representing 1.08% for $450 million. With this, the company has completed the repurchase of 5,449,701 shares, representing 3.58% for $1,450 million under the buyback announced on October 21, 2020.

Mirimus, Inc. Forms Strategic Collaboration with Biogen Inc. to Develop RNAi-Based Therapeutics for Neurological Disease Indications

2021-07-21 12:03:00

Mirimus, Inc. announced a strategic collaboration with Biogen Inc. focused on the development of RNAi-based therapeutics targeting multiple, undisclosed neurological disease indications. Terms of the collaboration between Mirimus and Biogen are undisclosed. Mirimus was established in 2010 with the goal of creating a scalable and cost-effective pipeline for model generation and therapeutic development by harnessing the power of RNAi and CRISPR technologies, including development of animal models crucial for preclinical evaluation of new therapeutics. Under the agreement, Mirimus will apply its expertise to engineer RNAi-based therapeutics that will be assessed by Biogen to determine feasibility in potential neurological disease settings. If feasibility is established, the companies will have the option to pursue pre-clinical development of the asset(s).

Biogen Inc. and InnoCare Pharma Limited Enter into License and Collaboration Agreement for Orelabrutinib

2021-07-13 00:00:00

Biogen Inc. and InnoCare Pharma Limited announced that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS). Orelabrutinib is a covalent BTKi with high selectivity and the ability to cross the blood-brain barrier, and is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS. Orelabrutinib inhibits BTK, which is a key enzyme that is part of the signaling cascade of immune cells including B cells and myeloid cells. With the ability to cross the blood brain barrier, orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS), and may provide a clinically meaningful benefit on progression in all forms of MS. By addressing the progressive biology of the disease, orelabrutinib may offer people living with MS an additional treatment option and the possibility to slow disease progression. Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

Biogen Inc., Q2 2021 Earnings Call, Jul 22, 2021

2021-07-08 12:23:00

Biogen Inc., Q2 2021 Earnings Call, Jul 22, 2021

Biogen Inc. to Report Q2, 2021 Results on Jul 22, 2021

2021-07-08 12:23:00

Biogen Inc. announced that they will report Q2, 2021 results Pre-Market on Jul 22, 2021

Biogen Inc. Announces FDA Approval of Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

2021-07-08 11:30:00

Biogen Inc. announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution. The update includes an addition to the Indications and Usage section of the label to emphasize the disease stages studied in the clinical trials. ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Alzheimer's Association, Alzheimer's Association International Conference, Jul 26, 2021 through Jul 30, 2021

2021-07-02 00:00:00

Alzheimer's Association, Alzheimer's Association International Conference, Jul 26, 2021 through Jul 30, 2021. Venue: Denver, Colorado, United States.

Enel X Collaborates with Biogen to Electrify Take-Home Vehicle Fleet in North America

2021-06-29 12:53:00

Enel X announced it is working with Biogen Inc. to electrify the global biotechnology company's employee commercial fleet. As a member of the Climate Group'sEV100, a global initiative of companies accelerating the global transition to electric vehicles (EVs), Biogen is committed to transitioning its global fleet of over 1,000 vehicles to EVs by 2025. This collaboration with Enel X advances progress on Biogen's Healthy Climate, Healthy Lives initiative to go fossil fuel free by 2040 and improve public health by advancing global targets for climate change and air pollution reduction. Enel X is providing Biogen with a turnkey fleet management solution, including JuiceBox smart charging stations and JuiceNet Fleet IoT software to manage the electric fleet through optimized charging times, and remote access control for station monitoring, as well as real-time monitoring and reporting. This will provide Biogen with the cleanest charging option for its take-home fleet, reduce Biogen's fleet operating costs over the lifetime of the EVs, and help balance the grid by utilizing off-peak charging, which generates bill savings for the customer and reduces strain on the grid during peak periods. Additionally, Biogen is providing its take-home fleet drivers with Enel X's JuiceEco, to match the energy consumed by each EV during charging with carbon-free electricity. Both Enel X and Biogen share commitments to 100% fleet electrification with aggressive targets. Enel, the parent company of Enel X, is committed to achieving complete decarbonization by 2050. Enel has outlined clear objectives certified by the Science Based Targets initiative (SBTi) around occupational health, sustainable supply chain, governance structure and environmental management.