6:38 PM
Feb 10, 2017
 |  BioCentury  |  Strategy

Building Bioverativ

How Biogen spinout Bioverativ plans to survive as stand-alone company

Biogen Inc.’s newly minted hematology spinout Bioverativ Inc. will have at least three years to build market share for its hemophilia therapies and flesh out its pipeline before gene therapies potentially hit the market. Given the level of competition, the newco has its work cut out for it, but CEO John Cox said it has the resources it needs.

Bioverativ launched Feb. 2 with a NASDAQ listing and Biogen’s hematology assets, which include two marketed long-acting clotting factor replacements and a portfolio of preclinical candidates.

Eloctate antihemophilic factor (recombinant) Fc fusion protein for hemophilia A and Alprolix coagulation factor IX (recombinant) Fc fusion protein for hemophilia B combined for 2016 sales of $888 million, and Bioverativ has guided for 2017 top-line growth of 19%.

Eloctate and Alprolix were the first of six long-acting factor replacements launched by four companies in the past three years. And gene therapies could soon shake up the space, if results from early trials showing reductions in the need for factor replacement therapies bear out in larger studies.

Bioverativ plans to bolster its portfolio by broadening the labels of its drugs to include patients who develop inhibitors to other factor therapies and by shopping for clinical stage hematology candidates beyond hemophilia.

In the meantime, the company expects to put one new follow-on factor product into the clinic this year and continue to develop its own gene therapies now in discovery for hemophilia A and B.

Naturally different

Launched in the U.S. in 2014, Eloctate and Alprolix were the first advance in the treatment of hemophilia in more than a decade. Prior to the drugs’ approvals, hemophilia patients were limited to short-acting factor replacement therapies dosed up to five times per week.

Alprolix and Eloctate are both approved as on-demand treatments to control bleeding episodes, for perioperative management of bleeding, and for routine prophylaxis. Swedish Orphan Biovitrum AB has rights to the products in Europe, Russia and the Middle East.

In clinical trials of Alprolix, hemophilia B patients received the therapy as prophylaxis every 10 days to maintain...

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