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BRISTOL-MYERS SQUIBB TESTIFIES IN CONGRESSIONAL HEARING ON DRUG PRICING

 NEW YORK, Jan. 25 /PRNewswire/ -- In comments made today before a Congressional hearing on "The Pricing of Drugs Co-Developed by Federal Laboratories and Private Companies," Bristol-Myers Squibb Company reported a number of major accomplishments in developing the anticancer drug Taxol(R) (paclitaxel).
 Zola Horovitz, Ph.D., vice president, business development and planning, Bristol-Myers Squibb Pharmaceutical Group, said, "Since the Cooperative Research and Development Agreement (CRADA) was signed with the National Cancer Institute two years ago, 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 limited period of exclusivity and the uniqueness of Taxol -- which 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 was never patented and no patent is possible, so the only exclusivity or protection the company has is the five years of protection from generic competition (Abbreviated New Drug Application) granted under Hatch-Waxman to every new drug. This limited exclusivity provides no protection against the introduction of new compounds, even if they are chemically related. Competition is expected in as little as two years from Taxotere, another drug in the taxane family being developed under an NCI CRADA by a French company, Rhone-Poulenc Rorer.
 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 exceptional, and that the Taxol project should stand as a notable example of public/private sector cooperation," said Dr. Horovitz.
 The National Cancer Institute expressed a similar view of the accomplishments of the Taxol CRADA process, as did several patient organizations and Dr. David Regan, President of the Oregon Society of Medical Oncology. Dr. Regan said, "The development of the new anticancer drug Taxol exemplifies the potential of the CRADA process." He added, "We are very concerned that active regulation of pricing will impair or destroy the financial incentives needed to encourage private pharmaceutical companies to participate in collaborative research projects under CRADAS."
 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 reported that Bristol-Myers Squibb has exceeded every goal set by it and the National Cancer Institute for Taxol's development.
 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.
 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.
 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. 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- 1/25/93
 /CONTACT: Nancy Goldfarb, 212-546-5107 or Jill Allread, Public Communications Inc., 312-558-1770, both for Bristol-Myers Squibb./
 (BMY)


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

LR -- NY038 -- 8396 01/25/93 10:50 EST
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