Monsanto Seeks Panel Support for Celebrex Cancer Use
Washington, Dec. 14 (Bloomberg) -- Monsanto Co. told a U.S. government panel that its blockbuster painkiller Celebrex also holds benefit for people with a rare genetic disease that leads to colon cancer.
The advisory panel for the U.S. Food and Drug Administration is weighing Monsanto's application to market Celebrex for a hereditary condition in which large numbers of polyps grow in the colon and intestine. The polyps place sufferers at high risk for colorectal cancer.
The market for the disease is small, analysts said. Still, a panel recommendation and FDA approval for the new use of Celebrex -- which has had generated more than $1 billion in sales this year -- would provide an endorsement of the anti-cancer potential of anti-inflammatory drugs like Celebrex, the company and analysts said.
''This would be an important step,'' Tom Brakel, an analyst at Mehta Partners said before the panel met.
Monsanto shares fell 1 1/2 to 40 5/8 in early afternoon trading.
'Consistent Improvement'
Monsanto is seeking FDA clearance for Celebrex use in treating familial adenomatous polyposis, or FAP, which affects about one in every 10,000 people. There are currently no drug treatments for what researchers called an ''uncommon but devastating disease.''
Untreated, 90 percent of people with FAP will contract cancer by age 50, and the average age of death for people with FAP is 42. Current therapies are limited to surgeries such as removal of polyps or of the entire colon.
Scientists told the panel that 400 mg of Celebrex, twice-a- day, reduced the number and size of the dangerous polyps in FAP patients who took the drug for six months.
''We saw a profound reduction in the number of adenomas (or polyps) throughout the colorectum,'' said Ernest Hawk, chief of gastrointestinal and other cancer research in the division of cancer prevention at the National Cancer Institute, who presented data studies of Celebrex. ''All the analyses confirm a significant, substantial and consistent improvement.''
The National Cancer Institute collaborated with Monsanto in planning and running the study.
The panel will vote on a recommendation later today, after hearing an FDA review of the data. The agency generally follows the advice of its expert committees.
FDA Questions
To win the panel's support, Monsanto will have to overcome questions about the importance of its findings.
The research tracked polyps found in the rectum, and in a portion of the intestine called the duodenum. While Celebrex seemed to have an impact on rectal polyps, the study showed no statistically significant improvement in the condition of the duodenum, the FDA said.
Coupled with the small size of the six-month long study, which looked at 83 patients, the duodenal findings raised FDA questions, in its written guidance to the panel, as to whether the company had proven enough benefit. In discussion this morning, panel members asked why the company hadn't done a larger trial which might have answered these questions.
''Why did you content yourselves with just a two-center trial and with potentially keeping the numbers (of patients) down, when you could have gone to several centers and potentially doubled your numbers,'' said Derek Raghavan, acting chairman of the panel and the head of medical oncology at the University of Southern California's Norris Comprehensive Cancer Center.
Monsanto officials said the disease was so rare that a big study was hard to do, but said it plans a larger study to show the drug's long term anticancer effects, if the new use is approved.
Scientists have long thought that older pain drugs such as aspirin might play a role in preventing some kinds of cancer. Risks of older non-steroidal anti-inflammatory drugs though have precluded their use in the high doses which may be necessary to have an impact on cancerous conditions.
Merck & Co., which markets Vioxx, a drug from the same class as Celebrex, is also studying its drug for use in cancer.
Dec/14/1999 13:21
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