JERUSALEM - Teva Pharmaceutical Industries Ltd. disclosed the first product, recombinant human growth hormone (hGH), or Bio-Tropin, to come out of its strategic alliance with Iselin, N.J.-based Bio-Technology General Corp.
The $20 million alliance, signed in September, gives Teva, of Jerusalem, exclusive U.S. marketing rights for generic recombinant therapeutic products that BTG will develop and manufacture.
The launch date for hGH could be delayed pending the outcome of appellate litigation between BTG and South San Francisco-based Genentech Inc. In January in New York, a U.S. District Court ruling invalidated a Genentech patent relating to the method for producing recombinant human growth hormone, thus lifting an injunction granted to Genentech in 1995 that barred BTG from marketing Bio-Tropin, following FDA approval of both BTG's Bio-Tropin and Norditropin produced by Denmark-based Novo Nordisk A/S.
Genentech filed a motion to preserve the injunction in the Federal Circuit Court of Appeals in Washington. If the appellate court reverses the District Court verdict, BTG would be barred from entering the market until the patent expires in 2003.
In the U.S., the pediatric market for recombinant human growth hormone is approximately $325 million. In 1998, Genentech captured about two-thirds of the market. But Teva is optimistic. Speaking from BTG's research and development headquarters in Rehovot, Teva President and CEO Eli Hurvitz said, "We are pleased that the first product derived from our strategic alliance has been revealed. Marketing hGH will be the first step in broadening Teva's activities in the expanding area of biotechnology."
"Our agreement with BTG is open-ended and not limited to a certain number of years. The $20 million paid consists of a $10 million up-front payment by Teva to BTG, which was paid in the third quarter of 1999, as well as $10 million more in milestone payments," Hurvitz said. BTG also will receive "a handsome double-digit royalty" on Teva's sales. "Several money-making biotech patents will expire over the next decade and BTG and Teva will be ready to compete for a share of the market with our generic products."