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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (734)	9/2/1998 2:38:00 PM
From: Anthony Wong	Respond to of 1722

Zeneca Wins FDA Panel Backing for New Tamoxifen Use (Update1) Bloomberg News September 2, 1998, 2:03 a.m. ET Zeneca Wins FDA Panel Backing for New Tamoxifen Use (Update1) (Adds panel action) Bethesda, Maryland, Sept. 2 (Bloomberg) -- Zeneca Group Plc, the world's No. 2 cancer drug maker, won the backing of an expert government advisory panel for its tamoxifen drug to reduce the risk of breast cancer in high-risk women. The U.S. Food and Drug Administration advisory panel voted to recommend agency approval of the new use of the drug, already a widely used treatment for breast cancer. ''The weight of the evidence is substantial,'' said Norman Wolmark, the principal investigator in the trial and the Chairman of the National Surgical Adjuvant Breast and Bowel Project Foundation, Inc., the government sponsored group which coordinated the study. ''The findings indicate that tamoxifen can reduce the risk of breast cancer.'' American depositary receipts of U.K.-based Zeneca rose 4 1/8 to 41. In recommending approval of the drug's use in healthy women, the panel expressed concern about its possible widespread use, because tamoxifen has been shown to have significant side effects including higher risk of uterine cancer and of potentially fatal blood clots. The panel is still discussing what labeling and restrictions it will recommend for the new use and what, if any, longer term studies it will recommend be done following an approval. Tamoxifen, also known as Nolvadex, is already a top-selling treatment for breast cancer, with sales of $500 million last year. Later today, the same panel will review Genentech Inc.'s Herceptin, billed as a revolutionary treatment for advanced breast cancer. Analysts predict a positive recommendation estimate Herceptin could generate sales of as much as $300 million a year within about five years. Genentech, one of the world's largest biotechnology companies, is majority owned by Switzerland's Roche Holding AG, the world's 11th-largest drugmaker. Herceptin first drew widespread attention at a major cancer meeting in May. Researchers there presented a study showing the drug could increase the time a woman can hold off a worsening of the disease and boost the chances she'll derive benefit from traditional chemotherapy. The FDA generally follows the advice of its panels, but is not bound by their recommendations. Questions About Risk The panel hearing on Zeneca's tamoxifen comes after a landmark study released in April found that the drug could prevent tumors in healthy women at high risk for breast cancer. At the time the FDA promised a speedy review of tamoxifen data. Since then, European studies have thrown those findings into question and today, some consumer groups and breast cancer organizations urged the panel not to approve wider use of the drug until more is understood about its risks. The conflicting studies raise the possibility that the drug only postpones the development of tumors and doesn't prevent them indefinitely -- an uncertainty which requires further study, they said. ''Women are entitled to expect that any drug approved for prevention of breast cancer will both actually prevent the disease and carry benefits that outweigh the risks of taking it,'' said Barbara Brenner, executive director of Breast Cancer Action, said in written comments to the panel. ''As far as we know now, neither is true'' for tamoxifen. San Francisco, California-based Breast Cancer Action is a patient advocacy group made up of women living with breast cancer. Critics of the drug told the panel they had concerns over its safety because an approval would mean it could be widely used by otherwise healthy women who might not ever develop breast cancer regardless of whether they take the tamoxifen. The drug attracted attention in April when U.S. researchers released a study of more than 13,000 women at high risk for breast cancer. The study found that the drug could reduce breast cancer rates in cancer-prone women by 45 percent compared to high- risk women who took no drug. It was the first study to suggest that any attempt to reduce the rate of breast cancer -- including lifestyle changes, diet or drugs -- could have a beneficial effect. The cause of breast cancer, one of the leading killers of women, is largely unknown. The U.S. findings were thrown into question in July, when two studies from the U.K. and Italy, which examined 7,900 women, showed no statistically significant differences between the rates of breast cancer suffered by women given tamoxifen versus those given a placebo pill. In winning the panel recommendation, the drug overcame reservations from panel members who questioned which women should receive tamoxifen. Still, panel members said uncertainty remains as to whether the benefits of tamoxifen will last, and whether they will outweigh the risks for the majority of the millions of women who could be eligible to receive the drug. If the drug does win FDA approval for the new use and other countries follow, Zeneca won't be the only company to benefit. The 25-year-old drug has lost patent protection in most countries and is sold by generic drugmakers such as Barr Laboratories Inc. Zeneca chief executive David Barnes said this year the company aims to overtake New York-based Bristol Myers Squibb Co. to become the world's No. 1 maker of cancer drugs. He said Zeneca is ''on track'' to achieve that goal by about 2002 or 2003, with 21 percent growth in sales of cancer drugs in 1997. --Kristin Reed in Bethesda, Maryland through the Washington