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| |  Humatrope Recommended by FDA for Turner Syndrome INDIANAPOLIS—Dec. 11, 1996 -- Eli Lilly and Company announced today that Humatrope(R) (somatropin (rDNA origin) for injection) was recommended, by a 6-1 vote, for marketing clearance for short stature associated with Turner Syndrome by the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration. The committee's recommendation, while not binding, will be considered by the FDA in its final review of the supplemental New Drug Application submitted by Lilly in July 1996. In a unique arrangement, Lilly and Genentech jointly presented medical data on their respective human growth hormone products for short stature associated with Turner Syndrome before the FDA advisory committee, reflecting a commitment by both companies to help meet the medical needs of a select patient population. Genentech's human growth hormone, Nutropin, also received a positive recommendation by the FDA advisory committee. Lilly and Genentech each filed drug applications independently with the FDA for human growth hormone for short stature associated with Turner Syndrome. The two companies have agreed to share orphan drug exclusivity for human growth hormone for the Turner Syndrome indication only. Turner Syndrome is a chromosomal disorder that affects females exclusively and is characterized, in part, by short stature and incomplete sexual development. Currently, between 50,000 and 75,000 girls and women in the United States have the disorder. Interim data from Lilly's clinical studies revealed that girls with short stature associated with Turner Syndrome who were treated with Humatrope from age 11 to age 15 or 16 attained, on average, an additional 5.4 cm in final height compared with patients with Turner Syndrome who were not treated with human growth hormone. "We are pleased with the advisory committee's positive recommendation based on the joint presentation of medical data by Lilly and Genentech," said John J. Chipman, M.D., a senior clinical research physician at Lilly. "Today's coordinated presentation reflects the commitment by both companies to help address the unmet medical needs of patients with Turner Syndrome." Humatrope is a synthetic human growth hormone (hGH) that has been used since 1987 as a replacement therapy for children who do not produce enough or any of their own hGH. In August 1996, the FDA cleared Humatrope for marketing to treat Somatropin Deficiency Syndrome (SDS) in adults, making Lilly's human growth hormone the first available therapy in the United States for adults who suffer from SDS. Humatrope already has been cleared for marketing in more than 30 countries for short stature associated with Turner Syndrome. Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions that enable people to live longer, healthier and more active lives. Endocrine diseases are one of five therapeutic areas in which the company is focusing its efforts. Humatrope(R) (somatropin (rDNA origin) for injection, Lilly)
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