Tuesday, Jun 18, 1996

Activase Cleared by FDA for U.S. Marketing

Genentech's clot-dissolving heart attack drug becomes first treatment for acute ischemic stroke

South San Francisco, Calif. -- June 18, 1996 --

Genentech, Inc. (NYSE: GNE) announced that the company's clot-dissolving agent, Activase® (Alteplase, recombinant), a genetically engineered version of the naturally occurring tissue plasminogen activator (t-PA), has been cleared for marketing by the U.S. Food and Drug Administration (FDA) for the treatment of eligible adult patients with acute ischemic stroke or brain attack within three hours of symptom onset. Activase is the first therapy to be indicated for the management of stroke, the country's leading cause of adult disability.

This new indication for Activase is based upon data from a nationwide clinical trial which showed that the relative recovery in eligible patients treated with Activase within three hours was at least 33 percent more likely to result in minimal or no disability than in those treated with placebo. The study was conducted by the National Institute of Neurological Disorders and Stroke (NINDS) and published in The New England Journal of Medicine on December 14, 1995.

The NINDS study found that out of every 100 patients treated with Activase within three hours of symptom onset as compared to placebo, at least (depending on the scale) 11 more patients demonstrated a favorable outcome at three months. A favorable outcome was defined as minimal or no disability using the four different stroke outcome scales. These results are statistically significant in favor of those treated with Activase. The trial utilized rigorous entry criteria to carefully select patients for treatment, including the requirements that initiation of treatment occur within three hours of symptom onset and a brain CT scan be conducted to rule out hemorrhage.

"The speed of review and marketing clearance is a clear reflection of our partnership with the FDA and NINDS investigators that ultimately benefits many stroke patients in this country," said Arthur D. Levinson, Ph.D., Genentech's president and chief executive officer. "Activase is now the only thrombolytic agent indicated for the management of acute heart attack, acute massive pulmonary embolism and acute ischemic stroke."

Not all patients with acute ischemic stroke will meet the eligibility criteria for Activase therapy. For example, patients with evidence of recent or active bleeding, recent stroke, uncontrolled high blood pressure or impaired blood clotting are not appropriate candidates for treatment. As with most drugs, benefits will vary among patients receiving Activase.

The most common serious side effect from this therapy was symptomatic intracranial hemorrhage. There were significantly more hemorrhages within 36 hours of treatment among the Activase treated population (6.4 percent as compared to 0.6 percent in the placebo group). However, no significant mortality differences were observed at 90 days between Activase and placebo groups (17 and 21 percent, respectively).

Need for Medical and Public Education

The availability of Activase to treat acute ischemic stroke within three hours of symptom onset will result in a paradigm shift in the way the disease is recognized and treated. Emergency teams, including neurologists, can now evaluate potential stroke patients to determine if they are appropriate candidates to receive Activase therapy. "We are entering a new era of stroke management in which medical and patient education will have to be emphasized. This new therapy will give key professional organizations and healthcare professionals an opportunity to prepare hospital teams and patients for optimal treatment of acute ischemic stroke. Acute ischemic stroke has now joined heart attacks and trauma as medical conditions for which emergency treatment reduces the risk of permanent disability,"said Dr. Levinson.

"Now that treatment for acute ischemic stroke is available for the first time, it is even more critical that the public regard stroke as a brain attack, recognize its warning signs, and seek emergency medical attention at the first onset of any of those signs, " said Harold W. Todd, president of the National Stroke Association.

The warning signs of stroke include:

  • Weakness/numbness in the face, arm or leg, especially on one side of the body
  • Sudden dimness, blurred or decreased vision, particularly in one eye
  • Difficulty speaking or understanding speech
  • Unexplained dizziness, loss of coordination, or sudden falls
  • Sudden or severe headaches with no known cause

Stroke is the number one cause of adult disability in America, with more than three million people living with the effects of stroke; more than one million of whom are severely impaired. According to the National Stroke Association, more than $30 billion is spent treating stroke victims annually; the average cost of treatment per patient for the first 90 days after a stroke is $15,000 and can go as high as $35,000. About 80 percent of all strokes are acute ischemic strokes caused by a blood clot stopping or diminishing blood flow to an area of the brain. Thus, acute ischemic stroke, or "brain attack," has comparable physiological cause as an acute myocardial infarction, or heart attack.

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, California, and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.

For full prescribing information, please call 415-225-2742.

Media Contacts: Paul Laland (415) 225-2742
Laura Leber (415) 225-5759
Investor Contact: Diane Schrick (415) 225-1599

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