FDA CLEARS TAXOL FOR MARKETING IN THE U.S.
NEW YORK, Dec. 29 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that it has received U.S. Food and Drug Administration clearance to market its new anticancer drug Taxol(R) (paclitaxel) for treatment of patients with ovarian cancer whose first-line or subsequent chemotherapy has failed. The company said it will provide Taxol free of charge to patients who are not insured or eligible for government assistance and who lack the ability to pay. The company also will continue to provide Taxol free of charge to the U.S. National Cancer Institute (NCI) for ongoing clinical trials. "We applaud the FDA for the speed with which it reviewed this New Drug Application. This is consistent with the massive concentration of resources and effort that the NCI, our company and others have devoted to making Taxol rapidly and widely available to cancer patients who may benefit from it," said Stephen K. Carter, M.D., senior vice president, Bristol-Myers Squibb Pharmaceutical Research Institute. Each year in the United States, approximately 21,000 women are diagnosed with ovarian cancer and 13,000 women die from the disease. Taxol, given the highest priority by NCI, is being brought to market less than two years after the NCI and Bristol-Myers Squibb signed the Cooperative Research and Development Agreement that enabled its rapid development. The company also expressed appreciation for the efforts of the U.S. Forest Service and Bureau of Land Management in expediting the collection of Pacific yew bark, currently the only approved source of Taxol for human use. "Over the past two years, we have made Taxol our number one research priority," said Leon E. Rosenberg, M.D., president, Bristol-Myers Squibb Pharmaceutical Research Institute. "Part of our commitment to Taxol involves a significant investment in the development of alternative sources, and our progress has been extremely rapid. In 1993, sources other than Pacific yew bark will begin to be used for Taxol production on a commercial scale. We now expect that by the end of 1995, Pacific yew bark will no longer be needed for the production of Taxol." The first of a new class of compounds, the taxanes, Taxol prevents cancer cells from multiplying by interfering with cell division in a unique way. More than 4,800 cancer patients have been treated with Taxol through NCI clinical trials and compassionate use programs since 1988. The drug currently is in Phase II clinical trials to determine if it is safe and efficacious for treatment of other tumor types. The net effective weighted average cost of Taxol per patient per cycle of therapy is $695.25. The actual cost of Taxol in individual cases will vary depending on how the patient obtains the drug. Patients receiving Taxol through the Bristol-Myers Squibb Taxol Patient Access Program will receive it free of charge. The company will also supply Taxol free of charge to NCI for continuing clinical trials and also to all patients started on Taxol prior to FDA clearance. Taxol will be sold to state Medicaid programs, certain Public Health Service clinics, and Federal government agencies at significant discounts. At full wholesale list price, the cost of Taxol per patient per cycle of therapy is $986.18. The Taxol Patient Access Program is designed to provide Taxol at no charge to patients who cannot afford the drug, do not have sufficient private insurance and are ineligible for government assistance. This program is accessed through physicians. In announcing the program, Isadore M. Pike, M.D., medical director, Bristol-Myers Oncology Division, said, "It is our intent that no patient be denied the drug because she is unable to pay for it." The company also has established a Taxol Reimbursement Assistance Program to help physicians obtain coverage for their patients from third-party payers. Taxol is administered intravenously at the recommended dose of 135mg/m2 by continuous infusion over 24 hours. The most significant side effects that may occur in patients receiving Taxol include: decreased ability to produce the blood cells that fight infection; allergic reactions; some heart conditions such as arrhythmia; gastrointestinal reactions; neurologic effects, such as numbness in the feet and hands; and hair loss. Patients should be premedicated prior to receiving Taxol to minimize allergic reactions, as specified in the official product package insert. Bristol-Myers Squibb is a diversified, research-based health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. -0- 12/29/92 /CONTACT: Nancy Goldfarb of Bristol-Myers Squibb, 212-546-5107; or Jill Allread of Public Communications, Inc., 312-558-1770, for Bristol- Myers Squibb/ (BMY)
CO: Bristol-Myers Squibb Company ST: New York IN: MTC SU: PDT
GK -- NY025 -- 0375 12/29/92 14:56 EST
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|Date:||Dec 29, 1992|
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