Bringing timely good cheer to the biotechnology industry, theFDA approved late Thursday Recombinate AntihemophilicFactor (Recombinant rAHF) developed collaboratively byGenetics Institute, Inc. (GI) and Baxter Healthcare Corporation,Hyland Division (Baxter).
News of the approval makes Recombinant rAHF only thesecond biotechnology product to make it through the FDA thisyear and Cambridge, Mass.-based GI's first U.S. productapproval.
The result of a 10-year research and developmentcollaboration between Baxter and GI, Recombinate rAHF is agenetically engineered form of the human blood clotting factorVIII for the treatment of hemophilia A, the most common formof hemophilia.
A recombinant factor VIII will eliminate the risk of productshortage associated with blood-derived factor VIII and,because the manufacturing process is not dependent uponhuman blood, greater quantities of the product can bemanufactured, according to Edward Gomperts, vice presidentand medical director at Baxter.
Recombinate rAHF is manufactured in tissue culture as opposedto being extracted from human blood and so the risk oftransmitting human viruses such as HIV and hepatitis areeliminated.
"This is a product which will really improve and benefit thequality of life for people with hemophilia," said Dennis Harp,GI's director of corporate communications. Harp added thatBaxter is prepared to launch Recombinate rAHF before the endof the year.
Harp said the company predicts an 85 percent marketpenetration for Recombinate rAHF in a patient population of20,000 by 1995, with anticipated revenues of between $200-300 million. According to a GI spokesperson, treatment forsevere hemophilia A currently runs about $50,000-70,000 peryear.
Also expecting imminent approval for a factor VIII product isthe Genentech Inc. of So. San Francisco, Calif., and Miles Inc.collaboration. GI's Harp said that to his knowledge, as ofThursday the FDA had not approved the Genentech/Milesproduct.
"Essentially the products are going to be in competition witheach other but if it turns out we have a lead because theirapproval is delayed, we'll be in a stronger position to enjoymarket dominance," Harp said.
Denise Gilbert, an analyst with Smith Barney in San Franciscobelieves the approval is important to the industry, but predictsthat it will have a more positive impact on the industry at largethan on GI itself.
Gilbert said the real issue for GI's Recombinate rAHF is how itwill be used, how the patient will be managed, and the cost."I'm not expecting it to have dramatic impact for the company- it won't be a profit-driver," she said.
-- Michelle Slade Associate Editor
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