Thursday, Oct 22, 1998
South San Francisco, Calif. and Cambridge, Mass. -- October 22, 1998 --Genentech, Inc. (NYSE: GNE) and Alkermes, Inc. (NASDAQ: ALKS) today announced that based on the successful completion of a multi-center Phase III clinical trial of Nutropin Depot and the preliminary results, the companies intend to proceed with plans to submit a New Drug Application (NDA) in early 1999 with the U.S. Food and Drug Administration (FDA). Nutropin Depot is a sustained release formulation of Genentech' s somatropin (recombinant human growth hormone or rhGH) based on Alkermes' ProLease® injectable sustained release drug delivery system. In the Phase III clinical trial, Nutropin Depot was administered either once or twice a month.
The Phase III clinical trial was designed to test the safety, tolerability and efficacy of Nutropin Depot in the treatment of children with growth hormone deficiency who had not received any previous treatment with growth hormone. Seventy-four patients were enrolled at 27 centers in the United States from December 1997 through March 1998. Two different dosing regimens were evaluated in the study -- both groups receiving the same total dose of Nutropin Depot. In one group, 36 patients received subcutaneous injections of Nutropin Depot once a month for a six-month period. In the second group, 38 patients received subcutaneous injections of Nutropin Depot twice a month for a six-month period.
The primary efficacy endpoint of the trial was linear growth rate at six months, annualized. All patients were given the option of continuing treatment with Nutropin Depot at the completion of the six-month study. Nutropin Depot is designed to reduce the frequency of injections by encapsulating the drug in biodegradable microspheres that, once injected, is intended to slowly release rhGH over a sustained period of time.
"Genentech looks forward to advancing the development of Nutropin Depot," said Arthur D. Levinson, Ph.D., president and chief executive officer at Genentech. "Our goal is to continue to provide patients and their families alternatives for growth hormone therapy."
"With the completion of this Phase III study, Alkermes is now focused on completing the validation and start-up of its manufacturing facility in Cambridge, Massachusetts," said Richard F. Pops, chief executive officer at Alkermes.
The complete analysis of the data from the study is currently underway. Final results are expected to be presented at a scientific meeting in 1999.
Alkermes, Inc. is a leader in the development of products based on sophisticated drug delivery technologies. Alkermes' focus is on two important drug delivery opportunities: controlled, sustained release of injectable drugs lasting several days to several weeks; and delivery of drugs into the brain past the blood-brain barrier. In addition to its Cambridge, Massachusetts headquarters and manufacturing facility, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Twelve of the currently marketed biotechnology products stem from Genentech science. Genentech markets seven products directly in the United States. The company has headquarters in South San Francisco and is traded on the New York Stock Exchange and the Pacific Exchange under the symbol GNE.
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