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NitroMed Readies for Drug Sales

NitroMed (NTMD) said Monday that its drug for treating congestive heart failure in African-Americans should be available within two to four weeks.

Michael Loberg, the president and CEO, didn't announce a price, but he said the drug BiDil will be "widely available" once the product launch begins. There will be "more than adequate quantities," he said.

Late Thursday after markets had closed, the Food and Drug Administration approved the drug, making it the first medication approved for a specific ethnic group. But the stock of the Lexington, Mass., company was halted Friday by the Nasdaq.

Loberg explained Monday, in a telephone conference call with analysts, that the Nasdaq halted trading because the company was negotiating with the FDA over the product expiration date for BiDil. The drug will have a 12-month expiration.

Since companies routinely manufacture products before getting FDA approval, the expiration-dating issue provoked questions from analysts who wanted to know if NitroMed might have unusable inventory. Loberg repeatedly said there wouldn't be any shortages.

Although BiDil is a patented product, it is a combination of two generic drugs -- hydralazine, for high blood pressure, and isosorbide dinitrate, for chest pains associated with heart disease. When asked by one analyst what the expiration dates were for the individual drugs, Loberg said he was not sure; but he added that he assumed the 12-month BiDil expiration was less than the expiration dates of the individual drugs.

Loberg reaffirmed his company's decision to market BiDil without a partner. NitroMed, which doesn't have any other products, has a 190-member sales force to promote the drug to physicians. "All launch elements are in place," Loberg said.

He said he believes that 85% of the African-American population of heart-failure age have some form of insurance coverage for the drug. The company is developing a patient assistance program for those who cannot afford the drug.
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