) 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
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
A few other companies that look equally well-positioned are
Cytori Therapeutics, Inc.
Protalix BioTherapeutics, Inc.
). All three are Zacks Rank #1 stocks.
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