Jul. 17, 2014, 8:42 AM
- Alkermes (NASDAQ:ALKS) initiates a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of ALKS 8700, an oral monomethyl fumarate (MMF) in development for the treatment of multiple sclerosis (MS). The randomized double-blind study will compare ALKS 8700 to placebo in 125 healthy subjects.
- ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features compared to Biogen's (NASDAQ:BIIB) Tecfidera.
Jun. 17, 2014, 7:26 AM
Jun. 16, 2014, 9:23 AM
- Joint developers Biogen (BIIB) and AbbVie (ABBV) announce positive top-line results for a Phase 3 clinical trial comparing subcutaneous daclizumab high-yield process (DAC-HYP) to intramuscular interferon beta-1a as a treatment for relapsing-remitting multiple sclerosis (RRMS). DAC-HYP achieved its primary endpoint of a statistically significant 45% reduction in annualized relapse rate.
- It also achieved statistical significance on the first secondary endpoint by demonstrating superiority compared to interferon beta-1a in reducing new or newly-enlarging T2-hyperintense lesions at week 96 by 54%. It did not achieve statistical significance in the second secondary endpoint of reducing the risk of three month disability progression as measured by EDSS.
- The companies plan to work with regulators to determine the appropriate timelines for filings.
Jun. 10, 2014, 7:46 AM
- Yesterday it was Biogen (BIIB). Today it's AstraZeneca (AZN). Isis Pharmaceuticals (ISIS) earns a $15M milestone payment from AZN by virtue of its initiation of a Phase 1 clinical trial for ISIS-ARrx, an antisense drug for the treatment of prostate cancer that works by inhibiting the production of the androgen receptor. Isis has now earned $57M to date on its development and is eligible for additional milestone payments as the product progresses through clinical trials.
Jun. 9, 2014, 9:27 AM| 1 Comment
Jun. 7, 2014, 4:56 PM
- The U.S. regulator clears Biogens' (BIIB) Eloctate (antihemophilic factor (recombinant) Fc fusion protein) for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia A. It is the first recombinant therapy with prolonged circulation in the body and it offers hemophilia patients the potential to extend the interval between prophylactic infusions. The recommended starting prophylactic regimen is 50 IU/kg every four days.
- In a 165-patient Phase 3 clinical trial of males 12 years and older with severe hemophilia A, prophylactic treatment with Eloctate achieved a statistically significant reduction of bleeding episodes compared to on-demand treatment. 98% of bleeding episodes were controlled with one or two Eloctate infusions.
- Biogen expects to launch the product commercially in the U.S. in July.
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
Apr. 23, 2014, 12:05 AM| Comment!
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