Thu, Jul. 2, 7:32 AM
- Biogen (NASDAQ:BIIB) and (NASDAQ:AGTC) enter into a collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The partnership will focus on the development of a portfolio of AGTC's therapeutic programs, including a clinical stage candidate and pre-clinical stage candidate, for orphan diseases of the retina that can lead to blindness in children and adults. The deal also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic disorder. Biogen will make an equity investment in AGTC and will have a license for manufacturing rights.
- Under the terms of the agreement, Biogen will make an upfront payment of $124M to AGTC, including a $30M equity investment at $20.63 per share and certain prepaid R&D expenses. Biogen will have a license to AGTC's XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection.
- AGTC is eligible to receive more than $1B in upfront and milestone payments, including up to ~$473M for the two lead programs, and high single-digit to mid-teen royalties on net sales. Biogen will makes payments up to ~$593M across the discovery programs including royalties on net sales in the same range.
- AGTC CEO Sue Washer says, "We expect this collaboration to further validate our novel adeno-associated virus (AAV) gene therapy platform and support the development of new therapies that may allow for transformative treatments of these rare inherited eye diseases and other clinical indications."
- AGTC will host a conference call this morning at 8:00 am ET to discuss the deal.
- AGTC is up 21% premarket on increased volume.
Fri, Jun. 26, 7:41 AM
- The European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) from Biogen (NASDAQ:BIIB) and Swedish Orphan Biovitrum AB (OTC:BIOVF) for Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein for the potential treatment of hemophilia B. The validation initiates the EMA's formal review process. A CHMP opinion could happen in Q1 2016 followed by a final decision from the European Commission ~60 days later.
- Alprolix is currently cleared for the treatment of hemophilia B in the U.S., Canada, Japan and Australia.
- Biogen and Swedish Orphan (Sobi) are collaborating on the development and commercialization of the product. Biogen has manufacturing and commercialization rights in North America and other regions of the world not covered by Sobi while Sobi retains the rights in Europe, North Africa, Russia and certain markets in the Middle East.
Wed, Jun. 10, 9:30 AM
- Biogen (NASDAQ:BIIB) and Samsung Bioepis announce results from separate Phase 3 trials comparing their biosimilar candidates to their respective reference products. The data were presented at the European League Against Rheumatism Annual Congress in Rome, Italy.
- 24-week data from one Phase 3 study comparing SB4 to the etanercept reference product Enbrel (NASDAQ:AMGN) in patients with moderate-to-severe rheumatoid arthritis (RA) showed equivalent efficacy. 596 patients were randomized to receive either SB4 (n=299) or Enbrel (n=297). The ACR20 (American College of Rheumatology: 20% improvement in RA symptoms) response rate at week 24 in the full analysis set was 73.8% in the SB4 arm versus 71.7% in the Enbrel arm. Full 52-week data will be available at a later date.
- 30-week data from a second Phase 3 comparing SB2 to the infliximab reference product, Remicade (NYSE:JNJ), in patients with moderate-to-severe RA also showed equivalent efficacy. 584 patients were randomized to receive either SB2 (n=291) or Remicade (n=293). The ACR20 response rate at Week 30 in the full analysis set for the SB2 arm was 55.5% compared to 59.0% in the Remicade arm.
- Data from a Phase 1 study assessing the pharmacokinetic equivalency of another biosimilar candidate, SB5, to its reference product, adalimumab [AbbVie's (NYSE:ABBV) Humira], will be presented as well.
- Samsung Bioepis is a joint venture between Biogen and Samsung Biologics.
Thu, May 7, 5:39 PM
Wed, Apr. 29, 9:22 AM
- The FDA accepts for review the Biologics License Application (BLA) for Zinbryta (daclizumab high-yield process) for the treatment of patients with relapsing forms of multiple sclerosis (MS). The drug was co-developed by Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV).
- 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.
- Zinbryta is the next-generation MS offering that builds on the success of Biogen's $2.9B blockbuster Avonex (interferon beta-1a).
- The European Medicines Agency validated (accepted for review) Zinbryta's Marketing Authorization Application (MAA) last month.
- Previously: Zinbryta trumps Avonex in MS trial (Sept. 12, 2014)
Fri, Apr. 24, 12:57 PM
- Privately-held French biotech medDay Pharmaceuticals reports results from a Phase 3 clinical trial (MS-SPI) evaluating MD1003, a pharmaceutical-grade biotin, for the treatment of primary and secondary progressive multiple sclerosis. The study met its primary endpoint in the intent-to-treat population with 12.6% of patients treated with MD1003 showing an improvement in EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9 compared to 0% for placebo (p=0.0051).
- Secondary analyses showed evidence of a decrease in the risk of disease progression. Mean EDSS scores in the treatment group between the start of treatment and Month 12 decreased (-0.03) compared to progression (+0.13) in the placebo cohort (p=0.015). Four percent of patients in the MD1003 group showed EDSS progression at Month 9 confirmed at Month 12 compared to 13% for placebo (p=0.07).
- Biotin is a B-vitamin known as vitamin H or coenzyme R. It plays a key role in cell growth, the production of fatty acids and the metabolism of fats and amino acids.
- The data were presented at the American Academy of Neurology Annual Meeting in Washington, DC. Full results will be submitted for publication in a peer-reviewed journal.
- MS-related tickers: (BIIB -5.9%)(SNY +0.3%)(NVS -0.9%)(TEVA +1.4%)(FWP -0.3%)(OPXA)(RCPT +0.1%)(CHRS -3.3%)(ABBV +1.7%)
Fri, Apr. 24, 7:47 AM
- Biogen (NASDAQ:BIIB) Q1 results ($M): Total Revenues: 2,554.9 (+20.0%); Net Product Sales: 2,172.3 (+24.6%); Joint Business: 330.6 (+11.4%).
- Key Product Sales: Tecfidera: 824.9 (+17.8%); Avonex: 692.7 (-9.0%); Tysabri: 462.6 (+4.9%); Plegridy: 61.8; Eloctate: 53.6; Alprolix: 43.1.
- Net Income: 820.2 (+70.9%); EPS: 3.49 (+72.8%); Operating Earnings: 1,221.6 (+50.8%); Net Earnings Yield: 32.1% (+42.4%).
- Updated guidance not provided in press release.
- Shares down 2% premarket on modest volume.
Fri, Apr. 24, 7:04 AM
Thu, Apr. 23, 5:30 PM
Wed, Apr. 22, 4:04 PM
- Hedge fund investor Kyle Bass, head of Dallas, TX-based Hayman Capital Management L.P., files a challenge to a key patent covering Biogen's (BIIB +0.6%) $2.9B Tecifera (dimethyl fumarate). Specifically, he is challenging the validity of U.S. Patent No. 8,759,393 entitled, "Utilization of Dialkylfumarates."
- Mr. Bass founded the group, Coalition for Affordable Drugs, which is targeting the '393 patent via a process called inter partes review, a type of patent challenge allowed by the 2012 American Invents Act. It was designed as a way to curtail the ballooning number of lawsuits by patent trolls. According to him, the group's raison d'etre is to stop companies from over-pricing drugs based on evergreening patents.
- Other companies in the crosshairs of the Coalition for Affordable Drugs include Shire (NASDAQ:SHPG) and Acorda Therapeutics (NASDAQ:ACOR).
Tue, Apr. 21, 12:38 PM
- Interim results from the first year of a two-year extension study (ATTAIN) of a Phase 3 trial (ADVANCE) evaluating Biogen's (BIIB) Plegridy (peginterferon beta-1a) in patients with relapsing-remitting multiple sclerosis (RRMS) show that continuous, fixed-dose treatment with Plegridy delivered robust long term efficacy. The results were consistent with those achieved in the ADVANCE trial.
- Patients with RRMS were administered Plegridy subcutaneously every two weeks for three years. In ADVANCE, the percentage of patients in the intent-to-treat population who achieved NEDA (no evidence of disease activity) was 34.8% in year one and 54.3% in year 2. In year one of ATTAIN, the proportion was 48.7%.
- The data were presented at the 67th American Academy of Neurology Annual Meeting in Washington, DC.
- Plegridy is a long-acting form of the company's top selling Avonex, which generated over $2.3B in sales the past four quarters. The FDA approved Plegridy in August 2014. It logged $41.1M in sales in Q4.
Tue, Apr. 21, 7:53 AM
- A new analysis of two Phase 3 trials shows that previously-treated patients with highly-active relapsing multiple sclerosis (RMS) who were treated with Novartis' Gilenya (fingolimod) had a 6x greater likelihood of achieving "no evidence of disease activity" across four key measures of disease activity compared to placebo over two years (p<0.0001). The disease status, called NEDA4, is achieved when an RMS patient has no relapses, no new MRI lesions, no MS-related brain shrinkage and no disability progression. It provides physicians with a more complete picture of an RMS patient's disease and response to therapy.
- A separate analysis of the data also confirmed that, after one year of treatment, RMS patients on Gilenya were 2x as likely to achieve NEDA4 as patients on Biogen's (NASDAQ:BIIB) Avonex (interferon beta-1a).
- The data were presented at the 67th American Academy of Neurology Annual Meeting in Washington, D.C.
- Gilenya is approved in the U.S. for the first-line treatment of RMS in adults and in Europe for adult patients with highly-active RMS.
Tue, Apr. 14, 12:05 PM
- The USPTO's Patent Trial and Appeal Board (PTAB) declares an interference between Forward Pharma's (FWP -1.3%) patent application 11/576,871 and Biogen's (BIIB -0.6%) issued patent No. 8,399,514. Both contain claims to methods of treating multiple sclerosis with 480 mg of dimethyl fumarate per day. Biogen's pertains to Tecfidera, which generated $2.9B in sales the past four quarters while Forward's pertains to its lead product candidate, FP187.
- The PTAB has designated Forward Pharma as the "Senior Party" in light of its earlier patent application filing date. This means that Biogen, as the "Junior Party," must prove that it is the first inventor. Should Forward prevail in the yet-to-be-scheduled hearing, its patent application will issue and Biogen's will be canceled, which obviously does not bode well for the fat margins it earns on Tecfidera. Biogen filed its patent application on February 13, 2012 while Aditech Pharma AG filed its application on October 7, 2005.
- An interference proceeding, also known as a priority contest, basically determines which party was first. It is a unique feature of U.S. patent law.
- Forward Pharma was created to exploit the patent family acquired from privately-held Swedish firm Aditech Pharma AG in 2010, which includes '871.
Wed, Apr. 1, 9:57 AM
- Receptos (RCPT -3.7%) completes patient enrollment in its RADIANCE Phase 3 study evaluating ozanimod (RPC1063) in patients with relapsing multiple sclerosis (RMS). The randomized, double-blind trial will assess whether ozanimod is superior to Biogen's (BIIB -2.7%) Avonex (interferon beta-1a) in reducing the annualized relapse rate in patients after two years of therapy.
- Ozanimod is an oral, once-daily selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed for the treatment of autoimmune diseases. It diminishes the activity of autoreactive lymphocytes (white blood cells) which is the cause of many types of autoimmune disorders.
- In a Phase 2 RMS trial, it achieved its primary endpoint of reduction in MRI brain lesion activity.
Mon, Mar. 30, 8:00 AM
- The European Medicines Agency (EMA) validates (accepts for review) the Marketing Authorization Application (MAA) for SB2, Biogen's (NASDAQ:BIIB) biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). The MAA was submitted by the firm's joint venture partner, Samsung Bioepis. This is the second MAA accepted for review by the European regulator. It validated the MAA for SB4, a biosimilar to Amgen's (NASDAQ:AMGN) Enbrel (etanercept), earlier this year.
- Both SB2 and SB4 will be manufactured at Biogen's Hillerod, Denmark facility, once approved.
Fri, Mar. 27, 7:30 AM
- The European Medicines Agency (EMA) validates the Marketing Authorization Application for Zinbryta (declizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS). The regulator's confirmation that the application is complete signals the start of the review process.
- Zinbryta is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion. It is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells and increasing CD56bright natural killer cells, which help regulate the immune system.
- Zinbryta is being jointly developed by Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV).
- Previously: Zinbryta trumps Avonex in MS trial (Sept. 12, 2014)
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