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 PMBiogen's Plegridy demonstrates long-term benefits to patients with difficult-to-treat multiple sclerosis
- 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 PMU.S. Patent Office declares an interference between Forward Pharma and Biogen over dimethyl fumarate
- 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)
Tue, Mar. 24, 7:14 AM
- Stifel Analyst Thomas Shrader downgrades Biogen (NASDAQ:BIIB) from Buy to Hold based on valuation. He agrees that the company is in driver's seat in neurological drug development, but notes that definitive data on BIIB037 is years away, as are revenues, while its safety could be an issue.
- Another significant risk is the Tecfidera patent fight with Forward Pharma, far from a certain win.
- His revenue model suggests the stock is worth $466 compared to yesterday's close of $463.73.
Mon, Mar. 23, 7:30 AMBiogen Idec shortens name; CEO says drug candidates in neurodegenerative diseases could pay off big in five years
- With a shortened name and new logo, Biogen (NASDAQ:BIIB) is entering a high risk-high return phase of its corporate life. CEO George Scangos, on board since 2010, is leading the firm into several difficult-to-treat areas in neurodegenerative diseases like Alzheimer's (AD), ALS and spinal muscular dystrophy. It won't take but one or two successes for the payoff to be huge.
- Shares jumped on Friday after the company announced positive Phase 1b results for its Alzheimer's candidate, BIIB037 (aducanumab). If the Phase 3, due to start later this year, is successful it could be the largest selling drug in history. As many as 75M people could be living with AD by 2030.
- Mr. Scangos says, "The future looks pretty exciting for us. If the Alzheimer's thing works, then we're not just an MS (multiple sclerosis) company. We are broadly focused on neurodegenerative diseases. Five years down the road, with some luck, we'll have an Alzheimer's drug that's getting approved. I hope we can transform the treatment of MS. By that time, we will have made substantial progress on ALS and nerve degenerative diseases, spinal muscular dystrophy in kids. All that stuff is on our plate. I am sure of two things, not all it is going to work, but some of it will."
- The company is also working on biosimilars to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) and J&J's (NYSE:JNJ) Remicade (infliximab).
Fri, Mar. 20, 10:37 AM
- Biogen Idec (BIIB +6.3%) jumps of double normal volume in response to its announcement of positive interim results of a Phase 1b study evaluating BIIB037 (aducanumab) for the treatment of patients with early-stage Alzheimer's disease (AD). Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain, the buildup of which is believed to play a key role in the development of AD symptoms.
- The interim analysis involved 166 patients up to Week 54 in four dosage cohorts: placebo, 1 mg/kg, 3 mg/kg and 10 mg/kg. A fifth arm, 6 mg/kg, involved 30-week data. The placebo arm was virtually unchanged at 26 and 54 weeks but there were statistically significant reductions in amyloid plaques in all dosage arms except 1 mg/kg at 26 weeks. At Week 54, greater reductions were observed in the 3 and 10 mg/kg arms (data from the 6 mg/kg arm was not available yet).
- Biogen group SVP and Chief Medical Officer Alfred Sandrock, M.D., Ph.D., says, "This is the first time an investigational drug for [AD] has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease. Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year."
- An estimated 25M people live with AD worldwide. Drug candidates that target amyloid plaque have not been successful in clinical studies to date.
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