) and Swedish Orphan Biovitrum AB recently presented new data on
their hemophilia B candidate, Alprolix, at the XXIV International
Society on Thrombosis and Haemostasis (ISTH) Congress.
Data presented by Biogen and Swedish Orphan Biovitrum
supported Alprolix' safety, efficacy and pharmacokinetic
According to the new data, one injection of Alprolix helped
control more than 90% of bleeds while more than 97% of bleeds
could be controlled by two or fewer injections. Moreover,
bleeding during and after 14 major surgeries were controlled by
Alprolix in 12 patients with hemophilia B.
Biogen and its partner, Swedish Orphan Biovitrum, had
initially presented positive phase III top-line results on
Alprolix last year. Results from the global, open-label,
multi-center B-LONG study had shown that Alprolix was effective
in controlling and preventing bleeding, routine prophylaxis, and
perioperative management. Results showed that a single injection
of Alprolix helped control 90.4% of bleeding episodes.
A pharmacokinetic analysis was also conducted. The approximate
terminal half-life of Alprolix was found to be 82 hours compared
to 34 hours for
The candidate was also found to be well-tolerated with no
inhibitors to Alprolix being detected or cases of anaphylaxis
(severe allergic reaction) being reported. Patients in the study
had all switched from marketed factor IX products.
Alprolix is currently under FDA review with a response
expected by year end. The company's hemophilia A candidate,
Eloctate, is also under FDA review.
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.
Meanwhile, Tecfidera should help drive long-term growth. We are
also encouraged by Biogen's progress with its hemophilia
A couple of other companies that look equally well-positioned
Protalix BioTherapeutics, Inc.
). Both are Zacks Rank #1 stocks.
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