Monday, Jun 28, 1999
South San Francisco, Calif. and Cambridge, Mass. -- June 28, 1999 --Genentech Inc. and Alkermes (NASDAQ:ALKS) today announced that Genentech has submitted a new drug application with the U.S. Food and Drug Administration for Nutropin Depot™. Nutropin Depot is a long-acting formulation of Genentech's recombinant human growth hormone (rhGH) using Alkermes' ProLease? injectable sustained-release drug delivery system. This new formulation was designed to reduce the frequency of injections by encapsulating the drug in biodegradable microspheres that, once injected, release rhGH slowly over a sustained period of time. Results of a Phase III clinical trial were reported at the Endocrine Society annual meeting in San Diego on June 13, 1999.
"We look forward to bringing Nutropin Depot -- the first long-acting form of recombinant growth hormone -- to the market, decreasing the number of dosings from 365 a year to 12 or 24," said Arthur D. Levinson, Ph.D., president and chief executive officer at Genentech.
"This is an important milestone for Alkermes and for our ProLease technology," said Richard F. Pops, chief executive officer at Alkermes. "We are pleased to be working with Genentech to bring this new therapy to growth hormone deficient children."
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufacturers and markets human pharmaceuticals for significant unmet medical needs. Twelve of the approved products of biotechnology stem from Genentech science, seven of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California.
Alkermes, Inc. is a leader in the development of products based on sophisticated drug delivery technologies. The Company has several areas of focus: (i) controlled, sustained release of injectable drugs lasting several days to several weeks, utilizing its ProLease and Medisorb® technologies; (ii) the delivery of drugs into the brain past the blood-brain barrier, utilizing the Cereport™ technology; (iii) oral delivery of drugs using its RingCap and DST technologies; and (iv) pulmonary delivery of small molecules and protein and peptide-based drugs utilizing its AIR technology. In addition to its Cambridge, Massachusetts headquarters, research and manufacturing facilities, Alkermes operates a manufacturing facility for Medisorb product candidates in Ohio and a medical affairs office in Cambridge, England.
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