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New Data on Biogen's Eloctate

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Biogen Idec (BIIB - Free Report) and Swedish Orphan Biovitrum AB recently presented new data on their hemophilia A candidate, Eloctate, at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress.

Data presented by Biogen and Swedish Orphan Biovitrum supported Eloctate’s safety and efficacy profile.

According to the new data, a single injection of Eloctate helped control more than 87% of bleeds while more than 97% of bleeds could be controlled by two or fewer injections. Moreover, bleeding during and after 9 major surgeries were controlled by Eloctate in 9 patients with hemophilia A.

Biogen also presented data on Eloctate from a population pharmacokinetics (popPK) model as well as an evaluation based on the usage of two investigational hemostasis assays.

We note that Biogen and Swedish Orphan Biovitrum had initially presented positive top-line results on Eloctate from the global, multi-center, phase III A-LONG study last year. About 98% of bleeding episodes were controlled with one or two injections of Eloctate. Eloctate was found to be generally well-tolerated.

Eloctate is currently under US Food and Drug Administration (FDA) review – a response regarding its approval status should be out early next year.

The company’s hemophilia B candidate, Alprolix, is also under FDA review with a response expected by year end.

A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help Alprolix and Eloctate capture share from existing products in the hemophilia market.

Biogen currently carries a Zacks Rank #1 (Strong Buy). Avonex and Tysabri should continue contributing significantly to sales. Tecfidera should help drive long-term growth. We are also encouraged by Biogen’s progress with its hemophilia candidates.

A few other companies that look equally well-positioned are Aeterna Zentaris (AEZS - Free Report) , Cytori Therapeutics, Inc. (CYTX - Free Report) and Protalix BioTherapeutics, Inc. (PLX - Free Report) . All three are Zacks Rank #1 stocks.

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