Biogen Idec's (NASDAQ:BIIB) Hemophilia Drug Works in Study

By Brett Chase  SEP 26, 2012 10:35 AM

The big biotech's shares rise after company says it will apply for US drug approval next year.


MINYANVILLE ORIGINAL Biogen Idec (NASDAQ:BIIB) is rising after the big biotechnology company said its experimental drug for hemophilia worked in a study and that it will seek US approval for the treatment in the first half of next year.

Biogen aims to shake up the treatment market for hemophilia, an inherited blood-clotting disorder that mostly affects males. People with hemophilia are missing or don’t have enough of one of the blood-clotting proteins, also known as factors. Biogen and drug development partner Swedish Orphan Biovitrum are testing a long-lasting, biotech treatment for patients with hemophilia B.

Shares of Biogen rose 3% to $157.02 in morning trading Wednesday. The stock is on a tear, rising 43% this year largely due to the strong sales of multiple sclerosis drugs and hope for a new MS treatment, known as BG-12, that may win US approval in the coming months.   

In a late-stage study of 123 male patients ages 12 and older, the hemophilia treatment was effective for controlling and preventing bleeding in patients, Biogen says. More than 90% of bleeding episodes were controlled by one injection, the company says. There was one “serious adverse event” possibly related to the drug, according to Biogen. That event related to a patient developing a condition in which the flow of urine is blocked, posing harm to the kidneys. That patient continued the treatment and the condition was resolved, the company says. Overall, Biogen said the treatment, known as a recombinant Factor IX Fc fusion protein, met its study goals to show effectiveness. The company plans to apply for US approval next year. A major benefit of Biogen’s drug is that it may require far fewer injections than already approved treatments.

Pfizer (NYSE:PFE) owns a top-selling hemophilia drug, BeneFix, a drug the big pharma company acquired with its takeover of Wyeth. Biogen, which also is testing a drug for the more common condition hemophilia A, acquired its drug with the takeover of closely held Syntonix Pharmaceuticals in 2007.

Denmark pharmaceutical maker Novo Nordisk (NYSE:NVO) is also testing a new hemophilia treatment. By beating Novo Nordisk to market in the US, Biogen likely would have a sales advantage, Leerink Swann analyst Marko Kozul says in a recent note.   

Twitter: @brettchase

No positions in stocks mentioned.

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