Jun. 6, 2014, 6:02 PM
- Biogen's (BIIB) Elocate has been approved for "the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A."
- Biogen declares Elocate is "the only treatment for hemophilia A to reduce the frequency of bleeding episodes with prophylactic infusions every three to five days."
- The drug is expected to be launch in the U.S. in July.
- BIIB +0.5% AH.
May. 28, 2014, 9:18 AM
- Array BioPharma (ARRY) and Biogen Idec (BIIB) sign a collaboration agreement for the discovery and development of inhibitors targeting a novel kinase for the treatment of autoimmune disorders that were discovered through ARRY's Kinase-Directed Phenotypic Screening Platform. Under the terms of the agreement, BIIB will be responsible for all aspects of clinical development and commercialization and will fund research for three years. ARRY will be eligible for certain development and commercial milestone payments and royalties on top-line sales.
May. 23, 2014, 11:25 AM
- Biogen (BIIB +0.3%) enjoyed the biotech boom, tripling in the three years ending in February, but the sector selloff has brought the stock down to bargain territory, writes Johanna Bennett in Barron's.
- "They have an embarrassment of riches with new drug candidates," says Cowen's Eric Schmidt. "The company can sustain a high growth rate and a high P/E multiple." Just this year, the company could launch three new drugs and should unveil clinical results on a number of others. "There is a lot of potential in Biogen's pipeline, and we will see those cards get turned over in the next 12 to 15 months," says ClearBridge's Marshall Gordon.
May. 20, 2014, 5:07 PM
- The FDA approves Takeda's Entyvio (vedolizumab) for the treatment of moderate-to-severe ulcerative colitis and moderate-to-severe Crohn's disease in adult patients who have not responded to one or more standard therapies.
- Vedolizumab is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells and function as bridges for cell-to-cell interactions. The mAb works by blocking the migration of circulating inflammatory cells across blood vessels and into areas of inflammation in the GI tract.
- Related tickers: (SHPG) (JNJ) (AZN) (BIIB) (ABBV)
May. 12, 2014, 12:10 PM
- The South Korean colossus is investing $2B in the biotech arena in an effort to drive growth from its $347B revenue base. Its main initial focus will be biosimilars with a planned 2016 launch in Europe of an Enbrel biosimilar and a 2017 launch of a Remicade biosimilar.
- The global market for biosimilars, while lagging in the U.S. due to regulatory uncertainty, is expected to grow to $24B by 2019.
- According to unit chief Christopher Hansung Ko, "Our mandate is to become No. 1 in everything we enter into, so our long-term goal is to become a leading pharmaceutical company in the world."
- Related tickers: (IBB) (JNJ) (AMGN) (BIIB) (XBI) (SSNLF) (SSNGY)
May. 12, 2014, 7:45 AM
- Biogen (BIIB) and Swedish Orphan Biovitrum agree to donate a total of 1B IUs of clotting factor for humanitarian programs in the developing world. 500M IUs will be donated to the World Federation of Hemophilia over the next five years. The remaining 500M IUs will be available for future distribution.
- An estimated 400K people live with hemophilia throughout the world with 300K living in areas with limited access to treatment. The 1B IU donation will enable physicians to treat more that 75K joint bleeding episodes, more than 2K life-threatening bleeding episodes and conduct thousands of otherwise-impossible elective surgical procedures.
Apr. 24, 2014, 8:18 AM
- The companies begin a 5-year strategic clinical development agreement to increase Biogen Idec's (BIIB) clinical trial efficiency. A dedicated Quintiles (Q) team will work on the design, planning and execution of Biogen's Phase 2, 3 and 4 clinical trials and a select number of Phase 1's.
- Biogen will leverage Quintiles' technology and systems across its portfolio of products.
- No financial terms are disclosed.
Apr. 23, 2014, 8:44 AM
- Top line revenues of $2.1B (+51%) driven by Avonex's $761M, Tecfidera's $506M, Tysabri's $441M and Rituxan & Gazyva's $297M.
- Revenue growth has accelerated for five consecutive quarters.
- The company recorded 100% of Tysabri revenues subsequent to its acquisition of the complete rights to the product in Q2.
- GAAP diluted EPS was $2.02 (+13%) and net income $480M (+12%).
- Full year guidance includes revenue growth of 26% - 28% and GAAP diluted EPS of $9.85 - $9.95.
Apr. 23, 2014, 7:04 AM
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Apr. 21, 2014, 10:28 AM
- Citi analysts post their list of 50 top Buy-rated stocks with a market cap of at least $3B, at least a top-three market share in a third of their businesses, and a global reach as measured by significant revenue outside of their home market; Business Insider highlights 20 according to estimated total return.
- Gilead Sciences (GILD) tops the list with a 45.4% ETR, and Citi believes GILD will generate a significant amount of cash and will buy back stock, engage in product and company acquisitions to grow its pipeline, and potentially start providing a dividend in 2-3 years.
- Rounding out the top 20: FB, BX, V, CERN, FLT, BA, MA, LVS, SBUX, MJN, GOOG, EBAY, BIIB, AXP, HOG, VFC, PII, VMC, FTI.
Apr. 10, 2014, 7:41 AM
- Biogen Idec's (BIIB) Eloctate long-lasting treatment for Haemophilia A, which the company is developing with Swedish Orphan Biovitrum (Sobi), maintained low bleeding rates in children under the age of 12 in a Phase III study.
- The results enable submission for EU approval. (PR)
- Separately, Biogen has named Ada Koppel as Chief Strategy Officer. Koppel comes from Brookside Capital, the public-equity affiliate of Bain Capital. (PR)
Apr. 9, 2014, 12:51 PM
- CEO Joe Jimenez taps Jeff George to run Alcon and Richard Francis to run Sandoz.
- Mr. George has been with Novartis (NVS +0.4%) since 2007 in various executive roles including the last five years managing Sandoz. He takes the helm of Alcon on May 1.
- Mr. Francis joins the company after a 13-year career at Biogen (BIIB +3.5%).
Apr. 4, 2014, 4:20 PM
- The recent selloff in Nasdaq momentum names spilled over to the rest of the stock market today, pulling the Dow and S&P sharply lower from their record highs hit earlier in the session.
- The S&P 500's 1.2% drop was less than half the Nasdaq's 2.6% plunge, but its 1,865 close was well below the 1,875 some technicians saw as a resistance level.
- The selling that started in biotechs a few weeks ago has carried over into cloud and enterprise software names, Internet and other high-flying tech names.
- Looking around Nasdaq, the carnage is evident: ICPT -9.6%, FEYE -8.2%, YELP -6.8%, TRIP -6.1%, TSLA -5.8%, ILMN -5.8%, SPLK -5.5%,NFLX -4.9%, PCLN -4.8%, FB -4.6%, GOOG -4.6%, BIIB -4.5%, CELG -4.3%, WDAY -3.8%, AMZN -3.2%, GILD -2.4%, TWTR -2%.
- Recent high-fliers also are seeing a surge in volatility to go along with their declines; the implied volatility of the iShares Biotech Fund (IBB -4%) is near its highest level in at least two years.
- Treasurys rallied as the latest employment report eased concerns that the Fed could raise interest rates sooner than expected; the 10-year yield fell 6 bps at 2.732%.
Mar. 28, 2014, 4:42 PM
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