[0] Genentech and Alkermes to Expand Clinical Development of Nutropin Depot.Business Editors SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif./CAMBRIDGE, Mass.--(BUSINESS WIRE) Jan. 8, 2001--Genentech, Inc. (NYSE NYSE See: New York Stock Exchange : DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. ) and Alkermes, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ALKS) announced today they will continue clinical development of Nutropin Depot(TM)(somatropin (rDNA) for injectable suspension) in adults with growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children . 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). 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 human growth hormone (HGH): see growth hormone. using Alkermes' ProLease(R) 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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(R) and Nutropin AQ(R) 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 South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. , and is traded on the New York Stock Exchange New York Stock Exchange (NYSE) World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. 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(R) 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(R) and Medisorb(R) technologies and (ii) the development of pharmaceutical products based on proprietary pulmonary drug delivery technologies utilizing its AIR(TM) 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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