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GENENTECH ANTICIPATES NUTROPIN rhGH APPROVAL BY END OF 1993

Executive Summary

GENENTECH ANTICIPATES NUTROPIN rhGH APPROVAL BY END OF 1993 as well as FDA approval for two other companies' recombinant human growth hormone products in that same time frame. Genentech indicated in its belief that Nutropin (somatropin) will receive approval by year-end in a patient infringement complaint filed with the International Trade Commission against competitors Novo Nordisk and Bio-Technology General, makers respectively of the pending rHGH products Norditropin and BioTropin. Genentech based its approval date prediction on "information and belief," that FDA "has requested Novo, like Genentech and...Bio- Technology General Corporation, to refile its NDA in March 1993 so that a final resolution can be made by the agency within about six to nine months." Approval by year-end would allow the three products to begin commercial sales immediately upon the March 1994 expiration of Lilly's orphan drug protection for Humatrope. The Nutropin NDA was originally filed on Dec. 23, 1986, the Norditropin NDA on May 16, 1987 and the BioTropin application in May 1991. The three products all have been blocked from marketing by the protection given to Lilly for its methionyl-free recombinant hGH. Genentech's Protropin, which differs from the other recombinant products in containing an additional amino acid not found in natural hGH, lost its orphan drug exclusivity in October 1992. An additional recombinant hGH product not named in the Genentech ITC complaint, Serono's Saizen, is also awaiting approval and the expiration of Lilly's exclusivity. Serono maintains that Saizen differs from the other hGH products because it is produced using mammalian cells rather than E. coli. The Genentech ITC complaint, which seeks to block impending competition from Norditropin and BioTropin, alleges that the production processes for the Novo and BTG products infringe upon three Genentech patients covering general methods for manufacturing recombinant proteins. Two of the Genentech patients are scheduled to expire in 1999 and the other in 2003. The complains charges that Novo Nordisk, Bio-Technology General and their agents "have begun the importation, distribution, and/or sale of infringing products with the aim of unlawfully acquiring a substantial share of the U.S. market for recombinantly produced hGH product." In addition, Genentech claimed, "each of the respondents has made clear its intent to significantly expand its importation, distribution, and/or sale of the infringing products immediately upon expiration in March 1994 of certain FDA regulatory restrictions." The complaint cites Novo as stating publicly that, "having registered the drug and received approval from the American health authorities," the company "will be able to launch Norditropin in the U.S." when Lilly's protection runs out in 1994. Genentech also alleged that Novo is announcing the approval process for Norditropin "in such a manner as to solicit investor interest in Novo's stock." These activities, together with ongoing enrollment of at least 200 patients for U.S. clinical studies at 20 centers across the country, are virtually guaranteeing Novo "not only the patients who have been enlisted for these studies, but also future patients and business through the involved hospitals and medical facilities," Genentech charged. Similar activities by Bio-Technology General "virtually guarantee future importation and sales of BTG's BioTropin hGH product in the U.S. market after completion" of BTG's clinical studies, Genentech alleged. In June 1991, BTG reacquired from DuPont Merck all rights to its recombinant hGH for use in treatment of children and data from Phase I and II studies in exchange for 275,000 shares of BTG common stock and royalties based on net sales of the product. The complaint quotes BTG President and CEO Sim Fass as claiming that BioTropin "will be approvable...essentially simultaneously' with the end of Lilly's orphan drug marketing exclusivity for Humatrope." In a Mach 17 response, BTG said it does not infringe any valid Genentech patent and noted that Lilly "is actively seeking to establish the invalidity and non-infringement by an authentic human growth hormone of Genentech's patents in the U.S." Genentech and Lilly are currently in litigation regarding the alleged infringement of several Genentech patents by Humatrope.

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