NitroMed Readies for Drug Sales

The CEO doesn't announce a price for BiDil but says it will be widely available.
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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



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.

NitroMed is talking to insurers about reimbursing patients for the drug. Loberg said he expects insurance coverage to be "widely available" at the highest level for a patient's copayment. Implicit in his comments was that discussions with insurers about BiDil's benefit and clinical trial results could convince them to place the drug in a lower tier, reducing a patient's out-of-pocket expenses.

A main selling point to insurers and doctors is the clinical trial known as the African-American Heart Failure Trial, or A-HeFT. The study included 1,050 self-identified black patients with severe heart failure.

A-HeFT results showed that BiDil patients had a 43% reduction in death and a 39% decrease in hospitalization for heart failure vs. patients taking a placebo. The trial was halted last year by an independent medical monitoring board, which said the results were so strong that the placebo patients shouldn't be denied BiDil. NitroMed conducted the A-HeFT trial with the aid of the Association of Black Cardiologists.

According to the Centers for Disease Control and Prevention, African Americans between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than Caucasians in the same age range. Of 5 million Americans diagnosed with heart failure, about 750,000 are African Americans.

Two earlier clinical trials of BiDil on a broader population produced inconclusive results, although these tests indicated that the drug could help African-Americans. Now that BiDil has been approved, federal law permits physicians to make "off label" prescriptions of the drug to other patients.

Another selling point for NitroMed is the FDA-approved label that says although BiDil treats congestive heart failure in African-Americans, neither of the individual components alone has been approved for congestive heart failure. Neither component has been "systematically studied" as a heart failure treatment. This label also could strengthen NitroMed's position against generic competitors.

NitroMed has two patents, expiring in 2020, relating to BiDil's treatment of African-Americans. A broader patent expires in 2007.

Shares of NitroMed were down 23 cents to $18.74.