Bristol May End The Development Of Diabetes Drug
By BARBARA MARTINEZ
Staff Reporter of THE WALL STREET JOURNAL
October 28, 2005
Bristol-Myers Squibb Co. said it may terminate the development of what was until last week seen as a potential blockbuster diabetes drug.
When the Food and Drug Administration surprised the company last week by withholding approval for the drug, Pargluva, saying it needed more information, many analysts assumed the delay would likely be no more than a year. But late yesterday, after the close of stock-market trading, Bristol-Myers said that the information that the FDA is seeking could take five years to obtain. As a result, the company said it will "consider a range of options including conducting additional studies or terminating further development" of Pargluva.
Bristol-Myers said it agreed to begin talks with Merck & Co. to terminate their partnership to market the drug. Before the FDA's move last week, Wall Street analysts had projected sales could top $1 billion within several years.
Bristol-Myers' consideration of scrapping Pargluva could reflect the new trepidation with which manufacturers approach troublesome side effects in the wake of Vioxx. Merck pulled its Vioxx painkiller from the market a year ago after it was linked to increased cardiovascular risks among a small group of patients. The company, as well as the FDA, has since faced a firestorm over drug safety and the approval process.
The FDA had asked Bristol-Myers this month for more information on the cardiovascular safety of Pargluva.
Bristol-Myers developed Pargluva and in April 2004 announced a deal with Merck to complete development of the drug and to help market it. The deal called for Merck to pay Bristol-Myers $100 million upfront and $275 million in additional payments based on regulatory milestones that are reached. The companies had hoped to win approval from the FDA this month and begin selling the drug next year.
Merck may have its own diabetes treatment available in the next year.
Last month, an FDA advisory panel strongly recommended approval of Pargluva. But this month the agency, which usually follows its advisory panels' recommendations, told Bristol-Myers that it wanted more information from the clinical trials to evaluate the drug's heart risk.
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