Biogen Idec BIIB and Swedish Orphan Biovitrum AB (Sobi) announced positive top-line results from a global, open-label, multicenter phase III study (Kids B-Long) on Alprolix for the treatment of children under age 12 suffering from severe hemophilia B.
The Kids B-LONG study evaluated the safety, efficacy and pharmacokinetics of Alprolix. Results showed that once-weekly prophylactic dosing with the drug reduced bleeding rates. Alprolix was found to be generally well-tolerated.
Based on the encouraging data from the study, Biogen and Sobi intend to file for regulatory approval in Europe later this year. Results from this study will also help support applications for pediatric indications in several other countries.
According to the company press release, hemophilia B affects nearly 4,000 people in the U.S.
Alprolix, which is developed and commercialized by Biogen together with Swedish Orphan Biovitrum, delivered sales of $76 million in 2014.
Apart from Alprolix, which caters to the hemophilia B segment, Biogen also has Eloctate, catering to the hemophilia A segment.
Meanwhile, Biogen is working on developing its pipeline. Last month, the company announced its intention to acquire Convergence Pharmaceuticals, which will add several therapeutic candidates for neuropathic pain to Biogen’s portfolio. The company also entered into an agreement with San Raffaele – Telethon Institute for Gene Therapy to jointly develop gene therapies for the treatment of both hemophilia A and B. Meanwhile, the company also has several candidates in different stages of development including Zinbryta (multiple sclerosis) and ISIS-SMNRx (spinal muscular atrophy).
Biogen is a Zacks Rank #2 (Buy) stock. Some better ranked stocks in the health care sector include Cambrex Corp. CBM, Isis Pharmaceuticals ISIS and Theravance Inc. THRX. All three are Zacks Rank #1 (Strong Buy) stocks.
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