Bristol-Myers Squibb Co. announced Tuesday that it hasreceived final FDA clearance to market its anti-cancer drugTaxol in the U.S. Company officials said the drug will becommercially available within the next two weeks.

FDA approved Taxol for the treatment of women with ovariancancer whose first-line or subsequent chemotherapy has failed.Ovarian cancer is diagnosed in 21,000 women and claims13,000 lives each year.

The drug is to be administered intravenously at arecommended dose of 135mg. per square meter of body bycontinuous infusion over 24 hours. Bristol-Myers (NYSE:BMY)has set the wholesale list price per patient per treatment cycleat $986. The "average" patient would receive a total of six toseven cycles in the course of her disease.

"The NCI (National Cancer Institute) has repeatedly stated thatTaxol is the most important cancer drug of the decade," IsadorePike, Bristol-Myer's medical director of oncology, told BioWorld."The quick approval shows us that the FDA recognizes theimportance of this drug."

Indeed, Taxol was approved a mere five months after Bristol-Myers submitted its new drug application (NDA) to FDA on July22.

Pike said that Taxol produced a 30 percent response rate(defined as tumor shrinkage) in the 192 ovarian cancerpatients who participated in five Phase III clinical trials usedas the basis of the company's NDA. Although Taxol did notstatistically affect mortality rates in the trials, it did improvethe "quality of life" for patients with "very far advanced"disease, he said.

Taxol is harvested from the bark of the Pacific yew tree, foundmainly in old-growth forests in the Pacific Northwest. It takesapproximately 60 pounds of bark -- the equivalent of threetrees -- to treat one patient with six or seven cycles of Taxol.Environmentalists have raised concerns over whetherharvesting Taxol could destroy the slow-growing Pacific yewsat an unacceptable rate. But Patricia Padgett Lea, an analyst atVector Securities International in Deerfield Park, Ill., said theenvironmental controversy will probably be moot by the endof 1993.

"Right now, Bristol-Myers is in the process of developing asemi-synthetic process to produce Taxol in-house from theneedles of the English yew tree," said Lea. "They are scaling upto 230 kg. capacity by the end of 1993. That's enough drug totreat more than 180,000 patients."

In addition, several other companies are working onalternative taxol production technologies, includingEscagenetics Corp. of San Carlos, Calif., and privately heldPhyton Catalytic Inc. of Ithaca, N.Y., which is collaborating withBristol-Myers. Both companies are developing technologies toproduce taxol using a plant tissue culture process. Rhone-Poulenc has developed a process to produce taxotere, acompound structurally similar to Taxol and produced fromneedles of the yew tree.

Lea said she expects off-label usage of Taxol to be widespreadsince the drug has shown activity in treating breast cancer andnon small-cell lung cancer. While the market for second-linetherapy of ovarian cancer is probably no larger than $20million, the market for second-line therapy of all three diseasescould be $400 million to $500 million.

"And if the drug shows better results than established first-linechemotherapy regimens in all three types of cancer, it could bea billion dollar drug for Bristol-Myer," Lea said. "But we won'tknow that for another two or three years."

-- Lisa Piercey Business Editor

(c) 1997 American Health Consultants. All rights reserved.

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