Monday, Dec 30, 1996
South San Francisco, Calif. -- December 30, 1996 --Genentech, Inc., (NYSE: GNE) today announced that it received clearance from the U.S. Food and Drug Administration (FDA) to market Nutropin&® [somatropin (rDNA origin) for injection] human growth hormone for the treatment of growth failure associated with Turner syndrome. The FDA's decision is based on complementary data from studies conducted independently and jointly presented by Genentech and Eli Lilly to the Endocrinologic and Metabolic Drug Advisory Committee on December 10.
Turner syndrome affects approximately one in 2,500 female live births. It is a chromosomal disorder that affects females exclusively.
"After more than 12 years of research, today's clearance provides Turner syndrome patients with a long-awaited treatment," says Arthur D. Levinson, Ph.D., president and CEO of Genentech. "It also demonstrates our extensive experience in studying and treating serious growth disorders, as well as our ongoing commitment to patients and the endocrine community."
Genentech currently markets Nutropin in the United States for children with growth failure due to inadequate growth hormone secretion and for children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin should not be used in patients with closed epiphyses (i.e. patients with no remaining growth potential.)
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco and is traded on the New York and Pacific stock exchanges under the symbol GNE.
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