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BRISTOL-MYERS SQUIBB RESPONDS TO CONGRESSIONAL HEARINGS

 NEW YORK, Feb. 24 /PRNewswire/ -- In response to comments made today before a Congressional hearing on "The Federal Government's Investment in New Drug Research and Development," Bristol-Myers Squibb Company (NYSE: BMY) issued the following:
 "Bristol-Myers Squibb takes great pride in the productive relationship it has had over the years with the National Cancer Institute," said Zola Horovitz, Ph.D., vice president, business development and planning, Bristol-Myers Squibb Pharmaceutical Group. "Although it should be noted that the great majority of Bristol-Myers Squibb cancer-fighting drugs were not licensed from NCI, we have worked very effectively with NCI to speed the development of a number of crucial cancer and HIV disease therapies and to make potentially life- saving pharmaceuticals as rapidly and widely available as possible to patients who need them."
 Dr. Horovitz noted that the company is particularly proud of Bristol-Myers Squibb's accomplishments, working with NCI, in developing the anticancer drug Taxol(R) (paclitaxel).
 "Since the Cooperative Research and Development Agreement (CRADA) was signed with the National Cancer Institute two years ago," he said, "we have made Taxol our number one research priority in an effort to make it rapidly and widely available. Taxol is now available to every woman in the United States who needs it. It is available at a fair price. And access to Taxol is assured, since we will supply it free of charge to anyone who needs it but cannot afford to pay.
 "Despite our company's huge investment, the high production costs, the uniqueness of Taxol and the limited period of exclusivity -- all factors which, combined, would normally command a premium price -- the projected cost per cycle of Taxol therapy is well below that of many other recently approved anticancer agents and is in the mid-range of other agents currently used in the treatment of ovarian cancer."
 Taxol is the first significant drug to be developed and cleared for marketing through the CRADA process. "The Taxol project provides tangible evidence that the CRADA process works as Congress intended," said Dr. Horovitz.
 Dr. Horovitz reported that despite having accepted unique and extraordinary challenges, Bristol-Myers Squibb has exceeded every goal set by it and the National Cancer Institute for Taxol's development.
 "I believe that the performance of the NCI, the other government agencies and Bristol-Myers Squibb has been exemplary, and that the Taxol project should stand as a notable example of public/private sector cooperation," said Dr. Horovitz.
 "It is important that future CRADAs not be threatened by politicizing pricing. Active government regulation of CRADA prices may appear to control costs, but instead is very likely to reduce the number of new drugs made available to patients or to delay their introduction significantly."
 As previously announced, 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 varies depending on how the patient obtains the drug. Patients receiving Taxol through the Bristol-Myers Squibb Taxol Patient Access Program receive it free of charge. The company also supplies Taxol free of charge to NCI for continuing clinical trials and to all patients started on Taxol prior to FDA clearance. Taxol is sold to state Medicaid programs, certain Public Health Service clinics, and Federal government agencies at significant discounts. At full wholesale list price, the highest price charged, the cost of Taxol per patient per cycle of therapy is $986.18.
 The National Cancer Institute has said: "For refractory ovarian cancer, patients receive treatment until they show signs of progressive disease. Thus, approximately 50 percent will receive 2-3 cycles of treatment while the remaining 50 percent, who have stable disease or respond to treatment, will be treated for an average of 5-6 cycles of therapy."
 Dr. Horovitz, in expanding on his statement that Bristol-Myers Squibb has exceeded every goal set by it and the National Cancer Institute for Taxol's development, reported the following:
 Since the CRADA was signed in January, 1991, Bristol-Myers Squibb has made Taxol its number one research priority. In only two years, the company has invested several times the $32 million spent on Taxol by the government -- and far in excess of the $114 million required by the CRADA. In addition, Bristol-Myers Squibb people have devoted more than 205 staff years to bringing Taxol to the patient -- which is also far in excess of the CRADA requirement of 125 staff years.
 The company agreed to gather, in 1991, 750,000 pounds of Pacific yew bark, which is still the only approved source of Taxol for human use. This target was dramatically higher than collection levels in prior years. Bristol-Myers Squibb actually collected 825,000 pounds of bark in 1991, and an equal amount was collected in 1992. About half of all bark collected was from federal lands.
 At a Congressional hearing on January 25, the company disclosed that, because of progress in developing alternative sources of Taxol, Bristol-Myers Squibb does not plan to harvest Pacific yew from federal lands in 1993.
 The second objective was to provide Taxol free of charge for NCI clinical research -- specifically, to provide one kilogram of formulated Taxol before the end of 1991, more than twice the amount of Taxol produced in 1990. This ambitious target was exceeded by more than a third with the delivery of 1.35 kilograms of bulk drug (45,000 vials). In January 1992, Bristol-Myers Squibb increased deliveries to NCI from 5,000 to 25,000 vials per month. In April, the company doubled shipments to 50,000 vials per month. This rate of shipping amounts to an annualized total of 16 kilograms of formulated Taxol -- more than 30 times the Taxol obtained by NCI in 1990, the year before the CRADA was signed.
 "It should be emphasized that Taxol is an extremely difficult drug to manufacture, and its development had been hindered for a number of years by very limited drug supply," said Dr. Horovitz. "The NCI could only manufacture enough Taxol to treat several hundred patients per year. Bristol-Myers Squibb has solved the supply problem."
 The company also agreed to initiate an aggressive search for alternative sources of Taxol.
 Bristol-Myers Squibb originally projected that it would be able to end reliance on Pacific yew bark within five to eight years. In actuality, much faster progress has been made. The company now reports that significant amounts of Taxol will be produced by semisynthetic means in 1993, and that it expects to eliminate the need for Pacific yew bark completely by the end of 1995 or earlier -- essentially accomplishing its objective in half the time originally anticipated.
 The final objective -- the most important from a patient's perspective -- was to file a New Drug Application within four years of signing the CRADA. The NDA was actually filed on July 22, 1992, only 18 months after signing the CRADA -- resulting in Taxol's being made available to patients who need it 2 1/2 years earlier than originally anticipated. The FDA Oncologic Drugs Advisory Committee recommended on November 16 that Taxol be approved, and FDA cleared Taxol for marketing on Dec. 29, 1992.
 -0- 2/24/93
 /CONTACT: Nancy Goldfarb of Bristol-Myers Squibb, 212-546-5107, or Jill Allread of Public Communications, Inc., 312-558-1770, for Bristol- Myers Squibb Company/
 (BMY)


CO: Bristol-Myers Squibb Company ST: New York IN: MTC SU:

TM -- NY074 -- 0116 02/24/93 17:27 EST
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