FDA May Delay Debut of Genentech Medicine

Genentech said Wednesday that a panel of the Food and Drug Administration will review Activase, the company’s form of tissue plasminogen activator (TPA), on May 29.

Analysts said the review by the FDA’s cardiorenal advisory committee may mean a two-month delay in the anticipated launch of Activase--a drug that is predicted to be the first genetically engineered pharmaceutical to generate $1 billion in sales.

Genentech, a South San Francisco-based biotechnology company, had been hoping to have FDA approval of the drug in time for a midyear launch. Although the review by the FDA committee is not extraordinary nor does it imply difficulties with approval for the drug, such a review is not always necessary. Many industry observers had been predicting that Activase would sail through the last phase of the regulatory process without it.

The drug, awaiting approval as a treatment to dissolve blood clots in heart attack victims, has gone through a variety of other regulatory steps, including a review last October of its manufacturing process. Some analysts, in anticipation of the cardiorenal panel’s review, had reduced estimates of the company’s earnings this year. Genentech’s stock price was up 50 cents a share on Wednesday, closing at $57.75 in over-the-counter trading.

Sarah Gordon, biotechnology industry analyst at Hambrecht & Quist in New York, said the investment firm has no doubts that the drug will be approved and that it would add significantly to Genentech’s revenue.

Gordon estimated that sales of TPA in the final four months of the year will bring in $95 million and that Genentech will have net income of $40 million for the year (including a large extraordinary tax credit). That’s little changed from H&Q;’s earlier estimates, Gordon said, because the company has increased to $2,500 from $1,500 its estimate of Activase’s cost of treatment, which should offset the shorter selling period this year.

Genentech said it has large quantities of Activase in inventory and would be ready to ship the product soon after approval.

Last year, the company reported a loss of $352 million, primarily because of the $432.5-million cost of buying out the research and development partnerships that developed TPA and other drugs for Genentech.