Genetics Institute Inc. filed its first marketing application with theFDA for approval of recombinant Factor IX, a blood clotting proteinused for treatment of hemophilia B, a less common form of thedisease than hemophilia A.
The Cambridge, Mass., company also submitted marketingapplications in Canada and Europe. The product would be the firstsold by Genetics Institute itself. The company will market Factor IXin North America and it has a distribution agreement with BaxterHealthcare Corp., of Deerfield, Ill., for sales in Europe.
Baxter already sells Genetics Institute's recombinant Factor VIII forhemophilia A under a worldwide licensing pact. About 50,000 peoplesuffer from hemophilia A, which is a deficiency of Factor VIII.
Genetics Institute's sales of the Factor VIII blood clotting protein toBaxter in 1995 totaled $83 million, nearly double the amount fromthe previous year. Genetics Institute also receives royalties.
Hemophilia B patients have a deficiency in production of Factor IX.About 3,000 people are affected by the disorder in the U.S., andanother 4,000 in Canada, Europe and Japan.
Plasma-derived clotting factors are the most common treatment forhemophilia, a genetic disease characterized by uncontrolled bleeding.Using recombinant proteins, which Genetics Institute produces inmammalian cell cultures, reduces supply constraints and risk ofcontamination from donor blood.
Genetics Institute's Factor IX would be the first recombinant versionon the market. Annual worldwide sales of plasma-derived Factor IXtotal about $150 million.
Clinical trial data in support of Genetics Institute's biologics productapplication with the FDA showed the drug controlled bleeding andwas as effective as the plasma-derived blood clotting protein.
Factor IX is the first of two blood-related products Genetics Instituteexpects to market in North America. The other is recombinantinterleukin-11, whose brand name is Neumega. The drug is in PhaseIII trials for platelet restoration in cancer patients undergoingchemotherapy.
Genetics Institute is a majority-owned subsidiary of American HomeProducts Corp., of Madison, N.J., which purchased a 60 percentinterest in 1991. The pharmaceutical firm's acquisition agreementincluded an option to buy the rest of Genetics Institute based on aprice that escalates to $85 per share by December 1996, when theoption expires.
Genetics Institute's stock (NASDAQ:GENIZ) closed Wednesday at$60.25, down 50 cents. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.