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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Andrew H who wrote (17534)	3/18/1998 8:19:00 AM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

Here's more on "off-label" cancer uses: W A S H I N G T O N, March 17 - U.S. Food and Drug Administration advisers are expected to approve later this week new uses of three drugs to treat various types of cancer. An FDA panel will meet Thursday and Friday to consider approval of the cancer drugs made by Roche Holdings Ltd., Eli Lilly & Co. and Bristol-Myers Squibb Co.. Two of the cancer drugs, Lilly's Gemzar (gemcitabine HCL) and Bristol-Myers' Taxol (paclitaxel), are already on the market and have proven safe and effective. The panel will decide on new uses for those drugs. Gemzar will be reviewed Thursday for treatment of non-small-cell lung cancer, which accounts for 75 percent of the 178,000 new Americans lung cancer cases each year. Approved in May 1996 in the United States for pancreatic cancer, Gemzar is a growing contributor to Lilly sales. It is already approved for non-small cell lung cancer in Canada, Spain, Italy, France and Germany. A Boon to Drug Makers In 1997, Gemzar sales were $175 million and could rise to $500 million in a few years as new cancer indications get added, said Mehta Partners analyst Sergio Traversa. He said he expects Gemzar approval for the lung cancer use. Later Thursday, the FDA panel will vote on Roche's Xeloda (capecitabine), a new drug for breast cancer patients who have not responded to Taxol or certain chemotherapy regimens. Xeloda is the first of a new class of cancer drugs called flouropyrimidine carbamates that promise fewer side effects than standard chemotherapies such as 5-fluorouracil (5-FU), since it works only within cancer cells. The company filed for FDA approval last October. Tumor Sizes Reduced "It should be a real advance compared to 5-FU," said Traversa. In early studies, Xeloda patients had a 50 percent reduction in tumor size. Xeloda is also working well in colorectal cancer, which will be a much larger market. Traversa said Xeloda sales should hit $75 million in 1998 if Roche gets approval for breast cancer. But "to compete, you have to show the drug is as safe as Taxol and at least as effective," Traversa said. Taxol will be reviewed on Friday for two new indications-as a first-line treatment for ovarian cancer and for non-small-cell lung cancer. An Alternative Therapy A hormonal agent, Taxol is already approved as an alternative therapy for ovarian cancer, and through "off-label" use, dominates the lung cancer market, according to the company. "We expect to see it approved in the lung cancer indication," said Merrill Lynch analyst Steven Tighe. He expects Taxol sales to hit $1.1 billion worldwide in 1998, up from $940 million in 1997. Tighe also said he expects approval for ovarian cancer, but said that indication would not add much to Taxol sales. There are about 26,800 new U.S. ovarian cancer cases each year.