Genentech Expects FDA to Approve New Asthma Drug This Week
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Posted by Dow Jones Business News on June 18, 2003 at 21:01:38:
SAN FRANCISCO -- Genentech Inc. (NYSE:DNA - News) expects the Food and Drug Administration (News - Websites) to approve its new drug Xolair for allergic asthma by the end of the week, a company official said, and plans to begin shipping the drug to distributors within 10 to 14 days.
If approved as expected, Xolair will be Genentech's first major drug to address problems caused by the immune system. Diane Parks, Genentech's chief of specialty biotherapeutics such as asthma drugs, said the company expects Xolair to kick off a new Genentech "franchise" in such products, much the way the company's successful cancer drugs have turned it into an oncology powerhouse. Xolair will also be the first biotechnology drug for asthma, which is currently treated with a variety of immunosuppressive drugs such as steroids. Xolair, by contrast, is an injected antibody that suppresses a particular protein responsible for inflammation. Later this year, Genentech also hopes to win approval for Raptiva, a new biotechnology drug for psoriasis. Ms. Parks said the company hopes to move another as-yet unidentified immunology-based drug from animal tests into human clinical trials later this year. Ms. Parks declined to say how Genentech will price Xolair, except to say that it will be in line with other biotechnology drugs that treat immune-related conditions. Such drugs can cost more than $13,000 a year at the wholesale level. Ms. Parks, however, cautioned that Xolair will take some time to penetrate its market, which consists of roughly 500,000 patients with moderate to severe allergic asthma that isn't controlled by existing drugs. She said the company is only expecting about four months of sales this year, and said that Xolair's main impact on Genentech's revenue won't occur until next year. Genentech must split that revenue with two partners, Novartis AG (NVS) of Switzerland and Tanox Inc. (NasdaqNM:TNOX - News; TNOX) of Houston. Once Xolair is approved, Genentech also plans to study its use in other indications such as pediatric asthma, allergic rhinitis and, potentially, peanut allergy, Ms. Parks said. The company also has high hopes for its cancer drug Rituxan, which selectively kills immune cells known as "B cells," in various immunologic diseases, including rheumatoid arthritis, multiple sclerosis and lupus. -By David Hamilton; The Wall Street Journal; 415-765-6116
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