Wednesday, Jun 6, 1990

FDA Approves t-PA for Pulmonary Embolism

SOUTH SAN FRANCISCO, Calif., June 6, 1990 -- Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) this week granted the company a license to market Activase, tissue plasminogen activator (t-PA), for the treatment of acute massive pulmonary embolism, or obstruction of the arteries of the lungs. Activase, a biotechnologically-derived product originally licensed for the treatment of patients with acute myocardial infarction, or heart attack, has now been proven to produce moderate or marked dissolution of blood clots lodged in the blood vessels of the lungs.

"The licensing of Activase for treatment of pulmonary embolism is an important step forward in realizing the full potential of clot-dissolving agents," said G. Kirk Raab, president and chief executive officer of Genentech. "We believe that the effectiveness of Activase has the potential to make it as important in the treatment of pulmonary embolism as it has become in the treatment of heart attacks."

Clinical trials of patients suffering from pulmonary embolism demonstrated that Activase provides safe and effective treatment.

"Among appropriately selected patients, t-PA works quickly and safely to help restore blood flow in acute pulmonary embolism," said Samuel Z. Goldhaber, M.D., staff cardiologist at Brigham and Women's Hospital in Boston, and associate professor of medicine at Harvard University Medical School. "It appears that thrombolytic agents may have an important role in reducing the complications that generally result from severe pulmonary embolism."

t-PA is an enzyme which is produced naturally in small amounts by the body to dissolve forming blood clots. In situations of respiratory or cardiac distress caused by blockage in the pulmonary or coronary blood vessels, the body is unable to produce its own t-PA in sufficient quantities to quickly dissolve the clots. Thus, Activase can be administered intravenously to more rapidly trigger the body's own clot-dissolving mechanism. By dissolving the clot , Activase restores critical blood flow, thereby helping to salvage the endangered lung tissue or heart muscle.

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

# # #