Monday, Apr 22, 1985
South San Francisco, Calif. -- April 22, 1985 --In response to inquiries regarding health risks associated with currently available pituitary-derived human growth hormone, and in the interest of the health concerns of children receiving growth hormone treatment, Genentech issued the following statement today.
Genentech utilizes recombinant DNA technology to produce Protropin®, a drug for the treatment of human growth hormone disorders. An application for marketing approval has been submitted to the Food and Drug Administration.
The current questions regarding human growth hormone (hGH) are related to the product which is extracted from the pituitary glands of human cadavers. When hGH is produced by recombinant DNA technology it is not susceptible to contaminants from human tissue because recombinant growth hormone is not derived from human pituitary glands.
Whenever substances are derived from human donors, there is a risk of transmission of disease. Until Genentech developed Protropin®, the only human growth hormone available in the U.S. and the rest of the world had been pituitary derived hGH. Treatment with recombinant growth hormone eliminates the risk of disease associated with products derived from human tissue.
Genentech was the first to clone, express and manufacture human growth hormone by recombinant DNA technology. The drug has been in human clinical trials since October 1981. Currently, 122 patients are being treated with Protropin® by pediatric endocrinologists at 11 major medical centers around the country.
The purpose of these trials is to demonstrate that Protropin® is safe and effective in promoting growth in children with growth hormone disorders. Results have been excellent.
In September 1984, the Endocrinologic and Metabolic Drugs Advisory Committee, which acts in the capacity of an expert scientific and medical council to the FDA, reviewed data Genentech's Protropin®. In its discussions, the committee indicated it agreed that Protropin® effectively increases the growth rate of children with hypopituitary dwarfism and appears to be safe based on the data seen to date. The committee recommended that data on a somewhat larger number of patients be reviewed before marketing approval. Genentech is presently supplying that information to the FDA.
What is Growth Hormone?
Growth hormone is a naturally occurring human protein produced by the pituitary gland at the base of the brain. It regulates certain aspects of metabolism and is the primary hormone promoting normal growth of bones and tissues. Children who don't have sufficient quantities of the hormone do not grow to their normal height. If untreated, these children would be very short as adults -- sometimes as short as 4' in height.
Growth hormone treatment, begun early enough, can enable the child to reach normal adult height. The longer treatment is delayed, the less likely he/she is to achieve normal height. However, if properly treated, the children will grow normally to, but not beyond (according to long term studies), their normal height.
Who is Genentech?
Founded in 1976, Genentech, Inc. is a leading biotechnology company, focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.
Genentech has been the leader in the science and commercialization of recombinant products for human health and has been manufacturing recombinant human growth hormone in significant quantities since 1980.
Simply stated, recombinant DNA is a process in which common microorganisms are used as mini-factories to produce pharmaceutical products such as human growth hormone in whatever quantity is needed.
The first and only recombinant pharmaceutical on the market today is human insulin. This product was created and developed by Genentech.
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