Biogen Idec Has BG-12, But What Excites Investors Next?
Stephen Simpson, CFA
Stephen Simpson, CFA
Tue, Jun. 7, 8:45 AM
- Biogen (NASDAQ:BIIB) slumps 9% premarket on increased volume in response to its announcement that its Phase 2 clinical trial, SYNERGY, evaluating opicinumab in patients with relapsing forms of multiple sclerosis (MS) failed to achieve its primary endpoint demonstrating an improvement in physical function and its secondary endpoint of slowing disability progression.
- SYNERGY was a randomized, double-blind, placebo-controlled study that assessed opicinumab in 418 participants with relapsing forms of MS (relapsing/remitting and secondary progressive) over 72 weeks. The primary endpoint was a composite measure of patients who experienced three-month improvement in ambulation, upper extremity function, cognition and standard measures of physical disability. Opicinumab was administered intravenously every four weeks at five different doses. All participants also received 30 mcg of interferon beta-1a once a week via intramuscular injection.
- The company continues to analyze the data to inform the design of its next trial.
Wed, Jun. 1, 12:25 PM
- Biogen (BIIB -0.3%) announces that its biologic candidate for Alzheimer's disease, aducanumab, has been accepted into the European Medicines Agency's (EMA) PRIME program, qualifying it for enhanced support from the EMA, including advice at key development milestones, and the potential for accelerated assessment of the Marketing Authorization Application (MAA).
- PRIME (PRIority MEdicines) is designed to improve patients' access to medicines that address unmet medical needs by increasing EMA's support in the development of investigational therapies. It is akin to Fast Track status in the U.S.
- Aducanumab, licensed from Neurimmune, is a recombinant monoclonal antibody derived from B cells from healthy elderly subjects with no signs of cognitive impairment or elderly subjects who are cognitively impaired but show unusually slow rates of decline. Two global Phase 3 studies, ENGAGE and EMERGE, are ongoing. The estimated final data collection date for the primary endpoint for both trials is February 2020. The estimated study completion date for both is February 2022.
Tue, May 31, 9:05 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Biogen's (NASDAQ:BIIB) TYSABRI (natalizumab) for use as disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT.
- The data supporting the company's application, called a type-II variation, was generated in a 10-year prospective real-study study called TOP (TYSABRI Observational Program).
- A final decision from the European Commission usually takes ~60 days.
Fri, May 27, 7:18 PM
- The FDA approves ZINBRYTA (daclizumab) a once-per-month self-administered injectable biologic, co-developed by AbbVie (NYSE:ABBV) and Biogen (NASDAQ:BIIB), for the treatment of adults with relapsing forms of multiple sclerosis (MS).
- Daclizumab is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit CD25, a protein that is over-expressed on T cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion.
- One negative is a boxed warning that daclizumab can cause liver injury. Patients are required to have liver function tests performed prior to starting therapy, before each monthly dose and up to six months after the last dose.
- ZINBRYTA's approval in the EU is imminent following a positive Ad Comm vote last month.
- AbbVie and Biogen have co-promotion rights in the U.S. and EU while Biogen has promotional rights elsewhere per the collaboration agreement between Fact Biotech and Biogen. AbbVie entered the picture when it acquired Facet, announced in March 2010, for $450M.
- Previously: Europe Ad Comm backs AbbVie and Biogen's MS drug Zinbryta (April 29)
Fri, May 27, 7:05 AM
- Interim data from a Phase 3 study, GALLIUM, show Genentech's (OTCQX:RHHBY) Gazyva (obinutuzumab) significantly reduced the risk of disease progression or death compared to Rituxan (rituximab) in treatment-naive follicular lymphoma patients. The trial compared the safety and efficacy of Gazyva plus chemo followed by Gazyva alone to Rituxan plus chemo followed by Rituxan alone. Complete results will be presented at an upcoming medical conference (probably ASCO).
- GALLIUM is a global, open-label, randomized, two-arm study assessing Gazyva and Rituxan for up to two years. Enrollment is 1,401 patients with previously untreated indolent non-Hodgkin's lymphoma of which 1,202 have follicular lymphoma. The primary endpoint is investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma. Secondary endpoints include PFS assessed by independent review committee, PFS in the overall study population, response rate, complete response and overall survival.
- Adverse events observed were consistent with previous clinical studies.
- Gazyva (branded as Gazyvaro ex-U.S.), developed with collaboration partner Biogen (NASDAQ:BIIB), is an engineered monoclonal antibody that binds to CD20, a protein expressed on certain types of B cells. It is believed to work by attacking targeted cells both directly and together with the immune system.
Thu, May 26, 5:09 PM
- The FDA approves CSL Behring's AFSTYLA [Antihemophilic Factor (Recombinant) Single Chain], its long-acting recombinant factor VIII single-chain therapy for the treatment of adults and children with hemophilia A.
- AFSTYLA is indicated for routine prophylaxis to reduce the frequency of bleeding episodes with dosing of two-to-three times per week, on-demand treatment and control of bleeding episodes and the perioperative management of bleeding.
- Market launch will commence this summer.
- Hemophilia A-related tickers: (NYSE:BXLT)(OTCPK:BAYRY)(NASDAQ:BMRN)(NYSE:OPK)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:BIIB)(NASDAQ:SGMO)(OTCQX:RHHBY)(NASDAQ:CBIO)
Mon, May 23, 4:52 PM
- The FDA accepts for review the Biologics License Application (BLA) from Samsung Bioepis for SB2, its biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). SB2 is the company's first biosimilar to be submitted for review in the U.S.
- If approved, Merck (NYSE:MRK) will be responsible for marketing and distribution.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB). It has 13 biosimilar candidates in its pipeline, including six in its first wave.
Mon, May 16, 12:21 PM
- Novo Nordisk (NVO +1.1%) submits its Biologics License Application (BLA) to the FDA seeking approval of its long-acting factor IX, nonacog beta pegol, for the treatment of patients with hemophilia B. The glycopegylated recombinant factor IX has a 5x longer half-life than standard factor IX products which enables once-weekly dosing.
- Related tickers: (BIIB +1.3%)(DMTX +8%)(QURE +2.9%)(SGMO -3.3%)(BAX +0.4%)
Mon, May 16, 10:55 AM
Mon, May 16, 10:01 AM
- Biogen (BIIB +0.5%) enters into a license agreement with REGENXBIO (RGNX +2.3%) for exclusive global rights to the latter's NAV AAV9 and AAV9 vectors for the treatment of two rare genetic vision disorders.
- Under the terms of the deal, the research license will convert to a commercial license upon the selection of a single vector for each indication. REGENXBIO will receive an undisclosed upfront payment, ongoing fees, milestones and royalties on net sales.
- REGENXBIO's NAV Technology platform is an AAV (adeno-associated vector) gene delivery platform consisting of exclusive rights to over 100 novel AAV vectors.
- The licenses are related to Biogen's funding collaboration with gene therapy researchers at the University of Pennsylvania.
- Previously: Biogen may invest up to $2B to fund gene therapy research at U Penn (May 16)
Mon, May 16, 9:11 AM
- Biogen (NASDAQ:BIIB) inks a collaboration and alliance with the University of Pennsylvania to advance gene therapy and gene editing technologies. The partnership will focus primarily on therapies for the eye, skeletal muscle and central nervous system, but will also include validating next-generation gene transfer technology using adeno-associated virus (AAV) gene delivery vectors and exploring the expanded use of genome editing technology as a potential therapeutic platform.
- The company will work with two recognized leaders in gene therapy at U Penn's Perelman School of Medicine: James Wilson, M.D., Ph.D., Professor of Medicine and Pediatrics and Director of Penn's Gene Therapy Program and Jean Bennett, M.D., Ph.D., Professor of Ophthalmology and Cell and Development Biology and Director of the Center for Advanced Retinal and Ocular Therapeutics.
- Under the terms of the agreement, Penn will receive an upfront payment of $20M and an additional $62.5M to fund R&D over the next three to five years in seven distinct preclinical programs. Each may trigger milestones ranging from $77.5M to $137.5M per product as well as royalties on net sales. The total potential value of Biogen's commitment could reach $2B.
- Separately, Biogen has licensed exclusive rights to certain AAV vectors from REGENXBIO (NASDAQ:RGNX) based on its NAV Technology Platform that were developed by Dr. Wilson's laboratory.
Fri, May 13, 7:36 AM
- The European Commission approves Biogen (NASDAQ:BIIB) and collaboration partner Swedish Orphan Biovitrum AB's (OTC:BIOVF) Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) for the treatment of hemophilia B. It is administered every 7-10 days so it provides prolonged protection against bleeding episodes as well as on-demand treatment.
- The data supporting the marketing application was generated in two Phase 3 trials, B-LONG, in adults and adolescents, and Kids B-LONG, in children under age 12.
- Swedish Orphan has final development and commercialization rights in Europe, North Africa, Russia and most of the Middle East. Biogen has commercialization rights in North America and the rest of the world ex-Swedish Orphan territory.
- Alprolix in now approved in the EU, U.S., Canada, Japan, Australia, New Zealand and certain other countries.
- Previously: Biogen's hemophilia B med successful in Phase 3 trial in children (Feb. 27, 2015)
- Related tickers: (NYSE:NVO)(NASDAQ:DMTX)(NASDAQ:QURE)(NASDAQ:SGMO)(NYSE:BAX)
Wed, May 11, 12:03 PM
- The European Commission approves CSL Behring's Orphan Drug-tagged IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B (factor IX deficiency). The labeling includes routine prophylaxis to prevent/reduce the frequency of bleeding episodes, on-demand control and perioperative management of bleeding. Market launch will commence in the next few months. Orphan Drug status means that IDELVION has a 10-year period of market exclusivity in the EU for the indication.
- IDELVION's principal value proposition is 14-day dosing. This is achieved via the maintaining of high levels of factor IX activity, above 5% over 14 days at 75 IU/kg, via the fusion with recombinant albumin.
- The FDA approved IDELVION in early March.
- Related tickers: (BIIB -0.8%)(NVO -0.1%)(DMTX -0.8%)(QURE -1.2%)(SGMO -0.2%)(BAX +1.9%)
Thu, May 5, 5:35 PM
Tue, May 3, 8:01 AM
- Biogen (NASDAQ:BIIB) will spin off its hemophilia business into a stand-alone company headquartered in the Boston area. EVP, Pharmaceutical Operations & Technology John Cox will serve as CEO.
- The spin-off, expected to be completed by the end of the year or early 2017, will be implemented via the distribution of 100% of the shares to Biogen stockholders.
- The as-yet-unnamed firm will be anchored by sales of ELOCTATE and ALPROLIX, which generated $640M over the 12-month period ending March 31. Product development will focus on bringing longer-acting therapies based on the XTEN technology into the clinic in H1 2017. Other strategic priorities include bispecific antibodies and hemophilia-related gene therapies.
- Management will host a conference call this morning at 8:30 am ET to discuss the spin-off.
Fri, Apr. 29, 12:35 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions recommending approval of new indications for Roche's (OTCQX:RHHBY -0.4%) Gazyvaro (obinutuzumab) and Avastin (bevacizumab).
- The thumbs up for Gazyvaro is the treatment of follicular lymphoma, in combination with bendamustine chemo, followed by maintenance therapy with Gazyvaro in patients who failed to respond to or progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen, an indication already approved in the U.S.
- CHMP's positive recommendation was based on results from the Phase 3 GADOLIN study which showed treatment with Gazyvaro reduced the risk of cancer worsening or death by 52%.
- Gayzvaro/Gazyva, a CD20-directed monoclonal antibody, is currently approved for the treatment of chronic lymphocytic leukemia.
- The thumbs up for Avastin is the first-line treatment, in combination with Tarceva (erlotinib), of adults with EGFR-positive, unresectable, advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). A mid-stage study, JO25567, showed treatment with Avastin extended progression-free survival by a median of 6.3 months. Avastin is currently approved for a range of cancers, including non-squamous NSCLC (in combination with carboplatin and paclitaxel).
- Final decisions by the European Commission usually take ~60 days.
- Related ticker: (BIIB -2.5%)
Biogen, Inc. is a global biotechnology company, which develops markets and manufactures therapies for people living with neurological, autoimmune and hematologic disorders. Its products include AVONEX, PLEGRIDY, TECFIDERA, TYSABRI, and FAMPYRA for multiple sclerosis, ALPROLIX for hemophilia B... More
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