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Bristol-Myers May End Plans for Oral Diabetes Treatment
  NY Times
Oct 28, 2005
Bristol-Myers Squibb said last night that it might abandon a proposed diabetes drug that it had been developing for years and had until recently hoped might become a blockbuster.
Dropping the drug, Pargluva, an oral treatment for diabetes, would be a setback for Bristol-Myers and its Pargluva marketing partner, Merck. The shares of both companies fell in after-hours trading, following Bristol-Myers's release of a statement discussing its options.
The company said it was weighing whether to drop the project or to conduct a five-year cardiovascular safety study that would be required to answer questions recently raised by the Food and Drug Administration. Bristol-Myers said it was in discussions with the F.D.A. about its next step and would "consider a range of options including conducting additional studies or terminating further development."
Bristol-Myers Squibb and Merck announced last evening that they had begun negotiations to dissolve their collaboration.
Pargluva, a treatment for Type 2 diabetes, would have been the first of a new class of drugs aimed at regulating blood sugar while also improving fat levels in the blood.
Bristol-Myers Squibb and Merck had hoped to begin marketing the product late this year. Some analysts had predicted that Pargluva would be a blockbuster, because 18 million Americans have Type 2, or adult-onset, diabetes. Bristol-Myers had wanted to be the first company to market with such a drug, called a dual PPAR-agonist, and had viewed Pargluva as an important addition to its product line.
Last month an F.D.A. advisory panel had recommended by a vote of 8 to 1 that the agency approve the drug. But the recommendation had stirred controversy, because the panelists who voted included no cardiologists, despite the fact that F.D.A. staff had raised questions about the drug's cardiovascular safety.
The F.D.A. said last week that it needed more information to approve Pargluva. At the time, the company had indicated that the F.D.A. questions could be handled quickly with existing data. Bristol-Myers said last night, however, that after discussions with the F.D.A., it had realized more studies were necessary.
"We have determined that to receive regulatory approval and to achieve commercial success, additional studies may be required because the ongoing trials were not designed to answer questions raised by the F.D.A.," the company's spokesman, Tony Plohoros, said in an e-mailed statement last night. "The additional studies could take approximately five years to complete."
Bristol-Myers, which is to report its third-quarter results today, made the announcement after the close of regular trading on Wall Street. After hours, Bristol-Myers shares were off $1.17, or 5.4 percent, to $20.50. Merck was off 75 cents, or 2.8 percent, at $26.17.
The F.D.A. decision last week to delay approval of the drug came several days before the release of a negative article and accompanying editorial in the influential Journal of the American Medical Association.
The article concluded that Pargluva doubled the risk of serious cardiovascular side effects, recommending that a long-term study be conducted before its approval.
One of the authors, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, said yesterday he was pleased that the F.D.A. was seeking a comprehensive safety trial of the drug. "If the company is confident of the drug's safety, they should do the trial," Dr. Nissen said. "But if they are not confident, they should kill the drug."
Merck had a relatively small share of the Pargluva deal, having given Bristol-Myers a $100 million upfront payment.
Merck also has its own new Type 2 diabetes product in development, one of another new class called DPP-IV inhibitors, which work by inhibiting the breakdown of a naturally occurring hormone involved in controlling blood sugar levels. Bristol-Myers has also said it is developing a DPP-IV.
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