Genetics Institute Inc. of Cambridge, Mass., was again blockedin its drive to win U.S. marketing approval for its Marogenerythropoietin (EPO) to treat anemia in people with chronicrenal failure.

Genetics Institute (NASDAQ:GENI) said that the Food and DrugAdministration denied citizens' petitions filed in 1989 and1990 by GI and its marketing partner, Chugai-Upjohn Inc. Theyhad asked that the FDA approve Marogen for chronic renalfailure despite the agency's previous grants of marketingapproval (1989) and orphan drug status (1988) for Epogen EPOmade by Amgen Inc., of Thousand Oaks, Calif.

Designed to encourage research into therapies for rare diseases,orphan drug status confers seven-year exclusive marketingrights on drugs to treat medical conditions afflicting fewer than200,000 people.

But GI contended that exclusive marketing rights should nothave been granted Epogen because the drug's patientpopulation exceeded 200,000 in 1988. The FDA rejected thatargument and a second argument that the drug indicationgranted for Epogen was not that requested by Amgen, whichhad applied to treat only end-stage renal failure with Epogen.The drug was licensed for treating chronic renal failure, whichencompasses a wider range of kidney disorders.

GI has sought alternative routes to bring Marogen to the U.S.market. One of them, a continuing patent battle with Amgen,will ultimately decide Marogen's fate, predicted analystMargaret McGeorge of Sutro & Co. in San Francisco.

GI holds a patent for EPO, and Amgen has another on asubstance considered essential for its efficient manufacture. AU.S. District Court in Boston ruled in late 1989 that the keyclaims of both patents were valid and that U.S. manufacture ofEPO by either side would infringe the other's patent.

However, the ruling alone would not impede GI's partner,Chugai-Upjohn, from making EPO in Japan and then selling it inthe United States. The ruling was appealed by both companies.If the court's decision is upheld, GI could use an offer of across-licensing agreement to bargain with Amgen forMarogen's entry into the U.S. market, McGeorge said.

Amgen spokesman Mark Brand would only comment, "The FDAdecision speaks for itself, and until a decision is reached by theCourt of Appeals, the status quo remains."

The FDA has yet to decide on a related citizens petition claim inwhich GI argued that the FDA, by granting Epogen's EPO orphanstatus, effectively emasculated U.S. patent law. GI also askedthat the FDA consider the two EPO brands as different products,allowing both to be granted orphan status.

"The FDA petition was one arrow in their quiver. They missedthe target this time, but they've still got a couple of arrowsleft," said Sutro's McGeorge.

GI's stock initially dropped Monday on the news to $35.75 ashare, but partly recovered to close at $37.75, down $1.75 forthe day. Amgen (NASDAQ:AMGN) closed at $59.75 a share,down 50 cents.

-- Rachel Nowak BioWorld Staff

(c) 1997 American Health Consultants. All rights reserved.

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