Sunday, Jun 13, 1999
South San Francisco, Calif. and Cambridge, Mass. -- June 13, 1999 --Genentech, Inc. (NYSE: GNE) and Alkermes, Inc. (NASDAQ: ALKS) today announced positive results of a Phase III multi-center trial of Nutropin Depot™ the first long-acting form of recombinant growth hormone. Presented at the Endocrine Society annual meeting in San Diego, final results demonstrated that Nutropin Depot increased growth rates in children with growth hormone deficiency (GHD).
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.
"While current growth hormone therapies require daily injections, Nutropin Depot requires just one or two dosings a month -- decreasing the number of dosings from 365 a year to only 12 or 24," said Principal Investigator Edward Reiter, M.D., Department of Pediatrics at Baystate Medical Center Children's Hospital in Springfield, Massachusetts.
The Phase III trial was designed to test the efficacy, safety and tolerability of Nutropin Depot in the treatment of children with GHD who had not received any previous treatment with growth hormone. Seventy-four patients were enrolled at 27 centers in the United States. The study evaluated two dosing regimens of Nutropin Depot once a month and twice a month -- with both groups receiving the same total dose. Results demonstrated that six-month growth rates of patients in both groups were improved from baseline, resulting in a positive change of the patient's height percentile accompanied by appropriate skeletal maturation and improvement in predicted adult height. Ninety-three percent of patients enrolled in the trial completed the study. Of these patients, the mean annualized growth rate was 8.4 cm per year, which is within the range of growth rates seen with daily growth hormone therapy.
"For more than 15 years, Genentech has been committed to pioneering the development of new advances in the field of endocrinology," said Arthur D. Levinson, Ph.D., president and chief executive officer at Genentech. "We look forward to bringing a new therapy option to growth hormone deficient children."
Growth hormone deficiency, GHD, is a pituitary disorder resulting in short stature and other physical ailments. It affects approximately 20,000 children nationwide. GHD occurs when the production of growth hormone, secreted by the pituitary gland, is disrupted. Since 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 in the hormone affects numerous body processes.
Genentech will submit a New Drug Application for Nutropin Depot to the U.S. Food and Drug Administration in the near future.
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 biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and the Pacific Exchange under the symbol GNE.
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 its Cereport(tm) technology; (iii) oral delivery of drugs using its RingCap(tm) and DST technologies; and (iv) pulmonary delivery of small molecules and protein and peptide-based drugs through its Advanced Inhalation Research (AIR) subsidiary. In addition to its Cambridge, Massachusetts headquarters, research facilities and manufacturing facility, Alkermes operates a manufacturing facility for Medisorb product candidates in Ohio and a medical affairs office in Cambridge, England.
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