Times are changing for Biogen Idec (NASDAQ:BIIB).
The longtime leader in the development of drugs for treating multiple sclerosis just expanded its territory. Last Friday, the Food and Drug Administration granted approval for Biogen's hemophilia B drug Alprolix. The big biotech developed Alprolix along with partner Swedish Orphan Biovitrum, or Sobi. Does the drug's approval mark a significant new frontier for Biogen?
A long time coming
Approval for Alprolix is unquestionably a big deal for patients suffering from hemophilia B. Biogen claims that the FDA's action was the most significant advance for the disease in over 17 years.
Therapies currently available often require multiple infusions per week. Alprolix typically only needs to be infused once per week and even less frequently for some patients. In the pivotal late-stage clinical study for the drug, more than 90% of bleeding episodes were brought under control by just one shot of Alprolix.
Biogen's new drug is the first to apply to hemophilia a process called Fc fusion, which has been used in other indications for more than 15 years. This approach involves fusing the factor IX enzyme to the fragment, crystallizable (Fc) portion of a common protein called immunoglobulin G subclass 1, or IgG1. Fc fusion prolongs the amount of time that the clotting therapy remains in the body.
With Alprolix bringing one of the most significant advances in hemophilia B therapy in nearly two decades, the drug holds the potential to be a winner for Biogen. Pfizer (NYSE:PFE) currently maintains a leading position in treating the rare disease with BeneFix. Last year, Pfizer reported $832 million in revenue from BeneFix. Will BeneFix patients now flock to Alprolix? Maybe, but there's a catch.
Morningstar predicts that Biogen will see peak annual sales for Alprolix of around $400 million. That's a hefty sum, but only around half of BeneFix's 2013 revenue and a drop in the bucket for Biogen, which racked up total revenue of almost $7 billion last year. It also may be an optimistic estimate, as some project that Alprolix will reach less than $300 million in sales by 2019.
The challenge for Alprolix is that it won't be the only game in town. Baxter (NYSE:BAX) gained approval for Rixubis last year for treating hemophilia B. The company also has BAX 335 in clinical studies targeting the indication.
Novo Nordisk (NYSE:NVO) possibly won't be too far down the road with its own long-acting hemophilia B drug. N9-GP is currently in a late-stage study.
The bigger picture
Even if Alprolix doesn't become a blockbuster drug for Biogen, the company's expansion into hemophilia looks like a smart move. Biogen awaits regulatory approval for hemophilia A therapy Eloctate. Morningstar thinks Eloctate could generate peak annual revenue of $700 million.
Biogen will likely run into familiar rivals assuming it wins approval for Eloctate. Both Baxter and Novo Nordisk also have new hemophilia A drugs in the works.
Multiple sclerosis appears to continue to be a mainstay for Biogen for the foreseeable future, particularly with the success of Tecfidera, However, the biotech's forays into other indications should be appreciated by investors -- and patients.