Monday, Jan 8, 2001
South San Francisco, Calif. and Cambridge, Mass. -- January 8, 2001 --Genentech, Inc. (NYSE: DNA) and Alkermes, Inc. (NASDAQ: ALKS) announced today they will continue clinical development of Nutropin Depot™ [somatropin (rDNA) for injectable suspension] in adults with growth hormone deficiency.
Genentech's decision to proceed to a Phase II/III clinical trial follows the completion of a Phase I trial of Nutropin Depot in growth hormone deficient adults. The results of this study will be reviewed with the U.S. Food and Drug Administration (FDA). The clinical trial will be funded by Genentech and conducted by Alkermes. It is expected to begin in the first half of 2001.
Nutropin Depot is a long-acting dosage form of Genentech's human growth hormone using Alkermes' ProLease® injectable extended-release drug delivery system and is indicated for the long-term treatment of growth failure in pediatric patients due to a lack of adequate endogenous growth hormone secretion. Nutropin Depot was approved for marketing by the FDA in December 1999.
"We look forward to working with our partner Alkermes to evaluate Nutropin Depot as a potential adult growth hormone deficiency treatment," said Stephen Dilly, M.D., Ph.D, Genentech's vice president of medical affairs.
"Alkermes is pleased with Genentech's decision to move forward with clinical development of Nutropin Depot," said Richard Pops, CEO of Alkermes.
Growth hormone deficiency occurs when the production of growth hormone, secreted by the pituitary, is disrupted. Growth hormone plays a critical role in stimulating body growth and development and is involved in the production of muscle protein and in the breakdown of fats. A decrease of the hormone affects numerous body processes. Genentech's daily growth hormone Nutropin® and Nutropin AQ® have been approved for use in adults since December 1997.
Genentech is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the approved products of biotechnology stem from Genentech science. Genentech markets nine products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
Alkermes is a leader in the development of products based on sophisticated drug delivery technologies. Its first product, Nutropin Depot, uses Alkermes' ProLease technology. The company has several areas of focus, including (i) controlled, sustained release of injectable drugs lasting several days to several weeks, utilizing its ProLease and Medisorb™ technologies and (ii) the development of pharmaceutical products based on proprietary pulmonary drug delivery technologies utilizing its AIR™ technology. In addition to its Cambridge, Massachusetts headquarters, research and manufacturing facilities, Alkermes operates research and manufacturing facilities in Ohio and a medical affairs office in Cambridge, England.
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Alkermes believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, there can be no assurance that: (i) clinical trials of the company's product candidates will be successful, completed on a timely basis, or at all, (ii) the company's partners will continue development of any product candidate to the point of receiving marketing approval from regulatory authorities, or (iii) the company's product candidates will be commercialized successfully.
Alkermes' business is subject to significant risks and there can be no assurance that actual results of the company's development activities and its results of operations will not differ materially from its expectations. For information with respect to other factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.
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