Thursday, Dec 23, 1999
South San Francisco, Calif. and Cambridge, Mass. -- December 23, 1999 --Genentech, Inc. (NYSE: DNA) and Alkermes, Inc. (NASDAQ: ALKS) announced today that Nutropin Depot [somatropin (rDNA origin) for injectable suspension] -- the first long-acting dosage form of recombinant growth hormone -- received approval from the U.S. Food and Drug Administration (FDA) for pediatric growth hormone deficiency (GHD) after being granted a six-month priority review.
In clinical trials, Nutropin Depot was shown to significantly increase growth rates in children with GHD. This new formulation requires only one or two doses a month (which may require more than one injection per dose) compared to current growth hormone therapies that require multiple doses per week (frequently daily).
"We are gratified by the FDA's accelerated review and approval in recognition of the potential Nutropin Depot holds for the enhancement of patient care," said Arthur D. Levinson, Ph.D., Genentech chairman and chief executive officer. "Nutropin Depot represents a significant advance in the evolution of growth hormone therapy providing growth hormone deficient children and their caregivers with a more convenient treatment option."
Alkermes has accelerated its manufacturing efforts, and Genentech expects to improve upon the original mid-year 2000 launch target date.
Nutropin Depot is a long-acting form of Genentech's recombinant human growth hormone (rhGH) using Alkermes' ProLease® injectable extended-release drug delivery system. This new formulation was designed to reduce the frequency of injections by encapsulating the drug in biodegradable microspheres.
"This new therapy option is exciting because I believe Nutropin Depot will lead to less disruption in the lifestyle of a number of my patients and their families," said Dr. Thomas Moshang, Professor of Pediatrics, Children's Hospital of Philadelphia.
In clinical studies, Nutropin Depot was tested for safety, tolerability and efficacy in children with GHD. Ninety-one patients enrolled at 30 sites in the United States were administered the same total dose of Nutropin Depot given once monthly or divided into two equal doses given twice monthly.
The most common adverse events associated with subcutaneous injections of Nutropin Depot were injection-site reactions, which occurred in nearly all patients and included redness (53%), post-injection site pain (47%) and nodules (61%). These events all resolved without further intervention. Nutropin Depot should not be used in patients with active tumors or acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or patients having acute respiratory failure.
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, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Twelve of the approved products of biotechnology stem from Genentech science. Genentech markets seven 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, 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 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 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.
For full prescribing information on Nutropin Depot, please call 650-225-7848.
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