Tuesday, Jan 2, 1990

Genentech Files FDA Application to Market Gamma Interferon in The United States

Marks FDA Division's First Electronic Filing

South San Francisco, Calif. -- January 2, 1990 --

Genentech, Inc., today announced that it has filed a Product License Application (PLA) with the U.S. Food and Drug Administration to seek approval to market recombinant gamma interferon to treat patients with chronic granulomatous disease. The drug would be used along with anti-microbial therapy for treatment of active infections as well as for prevention of infections.

Chronic granulomatous disease (CGD) is a rare inherited disorder in which the body's white blood cells are unable to function normally to kill invading bacteria or fungal agents. As a result, patients with CGD may suffer recurrent infections, some of which may lead to death. To date, the only therapy for these children is frequent doses of antibiotics to help prevent and fight acquired infections.

The electronic filing of the Product License Application for Actimmune™, (interferon gamma-1b) with the FDA's Center for Biologics Evaluation and Research is a first; it is expected that this new approach will result in time savings for the review officers. Rather than having to manually recreate graphs and tables based on clinical research study data included in the application submitted by the company, the review officers can work with the data submitted on specially-designed computer software programs. Genentech filed the PLA on December 20.

Genentech also is studying gamma interferon's ability to stimulate the immune system as a potential treatment in other indications. Phase III clinical studies continue to evaluate gamma interferon's safety and effectiveness in treating patients who have acquired infections relating to traumatic injuries, and as an adjuvant therapy in the treatment of patients with melanoma and small-cell cancer of the lung.

Gamma interferon, which has the brand name Actimmune™, is a drug developed by Genentech, through recombinant DNA technology, aimed at attempting to reduce the number and severity of CGD-related infections. The company was granted orphan drug designation by the FDA in September 1988 for gamma interferon's treatment of CGD patients, and holds three U.S. patents relating to the expression and manufacture of the drug.

Genentech, Inc. is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.

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