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August 11, 2014
10:50 EDTFWP, BIIBBiogen weakness attributed to Forward Pharma IPO filing
Shares of Biogen Idec (BIIB) came off their earlier highs and moved into negative ground in early trading, with some attributing the move lower to another pharmaceutical company, Forward Pharma (FWP), filing its registration statement with the SEC relating to a proposed initial public offering and reporting that Joel Sendek has been appointed CFO. WHAT'S NOTABLE: Forward Pharma focuses on a proprietary formulation of dimethyl fumarate, or DMF, for the treatment of multiple sclerosis. DMF is the Active Pharmaceutical Ingredient, or API, found in Tecfidera, which Biogen Idec began selling for the treatment of RRMS following approval by the FDA in March 2013 and approval by the European Commission in February 2014, Forward Pharma indicated in its IPO filing. In addition to its filing, Forward Pharma announced this morning that it has hired Joel Sendek from Stifel Financial, where he served as Managing Director, Biotechnology and led the firm's healthcare equity research group. PRICE ACTION: Shares of Biogen are down fractionally in mid-morning trading after being up over 1% soon after today's opening bell.
News For BIIB;FWP From The Last 14 Days
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October 9, 2015
07:32 EDTBIIBBiogen reports EVP of Global Commercial Operations leaving company
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October 8, 2015
06:32 EDTBIIBPiper Jaffray explains why drug prices are justifiable
Piper Jaffray's team of Biopharma analysts, led by Joshua Schimmer, explain this morning in research note to investors why they believe drug prices are justifiable. The "fairly lopsided" drug-pricing discussion "noise" has created attractive entry points for stocks in the sector, the analysts argue. They say that after adjusting for actual inflation, the growth of drug prices "does not seem particularly concerning." The current dialogue on the topic under-emphasizes the need to provide "extremely attractive incentives" for companies to embark on the "highly risky, capital-intensive, long-development cycle drug development path which is needed to bring new cures for important diseases," the analysts contend. Schimmer's top picks are Alexion (ALXN), Celgene (CELG) and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC) and Ignyta (RXDX) in the small-cap sector.
06:24 EDTBIIBBiogen and AbbVie's Zinbryta for MS improved cognitive results in Phase 3 study
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October 7, 2015
07:34 EDTBIIBAlliance for Regenerative Medicine to hold a meeting
Stem Cell Meeting on the Mesa is being held in La Jolla, California on October 7-9.
07:23 EDTBIIBEuropean Committee Treatment & Research in Multiple Sclerosis holds meeting
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06:04 EDTBIIBBiogen's Tecfidera shows efficacy in multiple sclerosis according to new data
Biogen will present new data that reinforce the proven efficacy and safety profile of Tecfidera in a broad range of people with relapsing-remitting multiple sclerosis at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain. The data show that Tecfidera significantly reduced multiple sclerosis relapses and delayed disability progression in patients who are newly diagnosed and those early in their disease course; these effects were sustained over six years of follow-up. New data also include a post-hoc analysis in which Tecfidera significantly reduced key inflammatory disease outcomes compared to glatiramer acetate and, in a separate analysis, Tecfidera demonstrated a favorable benefit-risk profile throughout six years of follow-up from the ENDORSE study. Tecfidera reduced annualized relapse rate by 63% and reduced risk of 12-week confirmed disability progression by 40%. A higher proportion of TECFIDERA patients were free of inflammatory disease activity at all time intervals over two years.
October 6, 2015
13:32 EDTBIIBBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
09:46 EDTBIIBDoc calls Biogen's Avonex price increase 'absolute insanity,' WSJ says
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October 5, 2015
10:19 EDTBIIBSpark trial success a positive for gene therapy sector, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said he views the news that Spark Therapeutics (ONCE) "highly anticipated" SPK-RPE65 Phase 3 gene therapy study for congenital blindness met its primary endpoint as a positive for the ophthalmology gene therapy field as well as the broader gene therapy sector. Schimmer added that Applied Genetic Technologies' (AGTC) early clinical data in the second half of this year will be a further test of the ophthalmology gene therapy platform. The analyst noted that other companies with gene therapy programs include Avalanche (AAVL), Biogen (BIIB), bluebird bio (BLUE), BioMarin (BMRN), Cellectis (CLLS), Medgenics (MDGN), uniQure (QURE), Pfizer (PFE), Regeneron (REGN) and Sangamo (SGMO).
October 1, 2015
07:34 EDTBIIBBiogen to present new Tecfidera data demonstrating importance of early treatment
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September 30, 2015
11:39 EDTBIIBStocks with call strike movement; BIIB HAL
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September 29, 2015
12:33 EDTBIIBOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday as the market seeks to break its losing streak, helped by an improvement in consumer confidence that came despite the recent market volatility. ECONOMIC EVENTS: In the U.S., consumer confidence unexpectedly rose in September. Analysts expected the consumer confidence reading to pull back to 96.8 from the prior 101.5 figure, but it actually strengthened to 103.0. The S&P/Case-Shiller 20-city composite home price index was up a seasonally adjusted 0.2% month over month in July, versus the consensus forecast for a rise of 0.1%. Stocks sold off in much of Asia last night, with China's Shanghai composite index sliding 2% while Japan's Nikkei dropped 4%, erasing year-to-date gains in the process. COMPANY NEWS: Shares of Yahoo (YHOO) advanced 3% after its board authorized the company to continue to pursue its spin-off of Aabaco Holdings, a newly formed independent registered investment company that will hold all of Yahoo's remaining holdings in Alibaba Group (BABA). MAJOR MOVERS: Among the notable gainers was Radius Health (RDUS), which rose nearly 10% after Ben Harrington of the Betaville blog stated during an appearance on Tip TV that he has heard that "something will be happening" in terms of M&A involving the company over the "next few weeks." Also higher were several recently beaten down biotech stocks that were seeing some bounceback, including Vertex Pharmaceuticals (VRTX), which gained 5%, and Biogen (BIIB), which advanced 4%. Notably, both of them, along with Amgen (AMGN), were mentioned in a note to investors by Cowen analyst Ken Cacciatore as "hypothetical" targets for Allergan (AGN). Among the noteworthy losers was OvaScience (OVAS), which dropped 38% after saying it now longer expects to meet its 2015 goal of 1,000 Augment cycles. Esperion (ESPR) also fell 38% after the company warned that the FDA could require it to undertake new studies before its ETC-1002 is approved. INDEXES: Near midday, the Dow was up 7.27, or 0.05%, to 16,009.16, the Nasdaq was up 7.38, or 0.16%, to 4,551.35, and the S&P 500 was up 4.56, or 0.24%, to 1,886.33.
08:57 EDTBIIBCowen lists Vertex, Biogen and Amgen as hypothetical Allergan targets
Cowen analyst Ken Cacciatore noted that the price agreed for Allergan's (AGN) generic divestiture to Teva (TEVA) is fixed and that the cash value from this deal has not depreciated in any way while the corresponding valuations of potential targets have corrected, increasing the potential value creation available for Allergan as it decides how to deploy its capital. To illustrate the value creation that Allergan's capital deployment could generate, Cacciatore estimates the type of accretion potential that might be seen if the company were to buy Vertex with an acquisition price of $36.5B, if it were to acquire Biogen (BIIB) at a price of $91B or if it were to purchase Amgen (AMGN) with an acquisition price of $140B. Although the market correction has lowered Allergan's stock, the decline could be viewed as a near-term positive, given that a key component of its strategy and business model is to seek to aggressively deploy its capital, Cacciatore argues in a note to investors. The analyst keeps an Outperform rating and $400 price target on Allergan shares.
06:06 EDTBIIBBiogen volatility at 52-week highs
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September 28, 2015
05:35 EDTBIIBBiogen implied volatility of 52 at upper end of index mean range
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September 25, 2015
12:38 EDTBIIBOptions with increasing implied volatility
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07:55 EDTBIIBBiogen, Sobi receive position opinion for Elocta from CHMP
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07:32 EDTBIIBBiogen, Sobi receive positive CHMP opinion for Elocta for Hemophilia A
Biogen and Swedish Orphan Biovitrum AB received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing authorization of ELOCTA. ELOCTA is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A that, if approved, would be the first hemophilia A treatment with prolonged circulation available in the European Union. The positive opinion was based on results from the pivotal, Phase 3 A-LONG clinical study, which examined the efficacy, safety and pharmacokinetics of rFVIIIFc in previously treated males 12 years of age and older with severe hemophilia A, and from the Phase 3 Kids A-LONG clinical study, which evaluated the efficacy and safety of rFVIIIFc in previously treated male children with hemophilia A under 12 years of age. The Committee's positive opinion is now referred to the EC, which grants marketing authorization for medicines in the EU. ELOCTA is the European trade name for rFVIIIFc, which is also known as ELOCTATE in the U.S., Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia A. Commonly reported adverse drug reactions in the clinical studies were arthralgia, malaise, myalgia, headache and rash. Development of Factor VIII neutralizing antibodies may occur following administration of ELOCTA. Biogen and Sobi are collaboration partners in the development and commercialization of ELOCTA/ELOCTATE for hemophilia A. Last year, Sobi exercised its opt-in right to assume final development and commercialization of ELOCTA in the Sobi territories. Biogen leads development for ELOCTA/ELOCTATE, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.

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