Thursday, Dec 18, 1997
South San Francisco, Calif. -- December 18, 1997 --Genentech, Inc. (NYSE: GNE), the leading supplier of U.S. growth hormone products, announced today that Nutropin AQ® -- the only liquid (aqueous) recombinant human growth hormone product which does not require reconstitution of a freeze-dried powder -- received market clearance from the U.S. Food and Drug Administration for the replacement of endogenous growth hormone (GH) in patients with adult growth hormone deficiency (GHD). Yesterday, in a separate announcement, Genentech announced that the company received clearance to market Nutropin® -- its original lyophilized (powdered) product -- for adult GHD.
Somatropin replacement therapy (SRT) is recommended for adults who meet specific criteria including a diagnosis of GHD by means of a subnormal response to a standard growth hormone stimulation test as well as the experience of adult GHD due to pituitary disease, tumor or trauma, or from childhood onset of the condition. It is important that children diagnosed with GHD and treated with growth hormone are retested after they achieve adult height.
"Somatropin replacement therapy has been shown to improve some of the symptoms of adult growth hormone deficiency such as altered body composition and abnormal lipid metabolism," said Lawrence S. Phillips, MD, Professor of Medicine and Director of the Division of Endocrinology and Metabolism at Emory University. "It's important to replace what is missing -- similar to replacement therapies for other hormone deficiencies."
Two trials were conducted -- one looking at patients with childhood onset GHD and the other observing patients with adult onset GHD. In clinical trials designed to assess the effects of SRT in adults with GHD, both studies showed that patients receiving SRT experienced significant decreases in total body percent fat and trunk percent fat with increases in percent lean mass.
In the adult-onset study, patients with adult GHD who were treated with SRT demonstrated a statistically significant decrease in LDL cholesterol compared to the placebo group, resulting in significant improvement in LDL:HDL ratio -- an indicator of cardiac risk. There were no statistically significant differences from placebo for total cholesterol, HDL cholesterol or triglycerides. In the childhood-onset study, significant decreases in total cholesterol, LDL cholesterol and LDL:HDL were seen in the high dose SRT group only, compared to placebo. There were no statistically significant differences in HDL cholesterol or triglycerides.
The most common side effects reported by GH deficient adults were dose related and included edema or swelling (41 percent Nutropin vs. 25 percent placebo patients), joint pain (27 percent Nutropin vs. 15 percent placebo) and carpal tunnel syndrome. In GH deficient adults, Nutropin was associated with an increase of insulin levels; therefore, patients with diabetes should be monitored closely. Nutropin AQ and Nutropin should not be used in patients with active tumors. Experience with prolonged GH treatment in adults is limited.
"Today's clearance truly reflects Genentech's long-standing commitment to patients of all ages, as well as its dedication to serving the endocrine community," said Arthur D. Levinson, Ph.D., president and chief executive officer of Genentech. "As part of that continuing commitment, Genentech plans to dedicate resources to a post-approval observational surveillance to assess the long-term effects of somatropin replacement therapy in adults - much like the National Cooperative Growth Study founded in 1985 to observe the long-term effects of growth hormone therapy in pediatric populations."
Genentech, who more than 15 years ago pioneered the development of the first recombinant growth hormone product, maintains its leadership in the US market today. The company currently markets Nutropin AQ and Nutropin in the United States for children with growth failure due to inadequate growth hormone secretion, for children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation and for the long-term treatment of short stature associated with Turner syndrome. Nutropin AQ and Nutropin should not be used for growth promotion in pediatric patients with closed epiphyses (i.e., patients with no remaining growth potential) or in patients with active tumors.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science. Genentech markets or promotes eight biotechnology products in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
# # #