NitroMed suspends marketing of heart drug BiDil, cuts staff

From FDA News
(January 16, 2008) The maker of the first medication approved for use in a specific racial group is halting marketing of the blacks-only heart drug, laying off most of its 90-person staff and exploring a possible sale of the company.

NitroMed Inc. says it lacks the cash and marketing muscle to make its 2 1/2-year-old drug BiDil a commercial success, although the firm hopes to turn things around after it seeks approval in a couple years for a once-a-day tablet to succeed the current three-times-a-day formulation.

An industry analyst says the cost-cutting moves NitroMed announced after markets closed Tuesday do not necessarily cast a cloud over the expected emergence of other drugs tailored to individuals' genetic make-ups.

BiDil was approved in 2005 only for use by the estimated 750,000 U.S. blacks with heart failure, and was the first - and so far only - race-specific drug approved by the FDA. BiDil is a combination of two drugs that boost the amounts of nitric oxide in the blood - a substance found in lower levels in some blacks that has several roles in heart health.

Liana Moussatos, of Pacific Growth Equities, said BiDil has been hampered by concerns about the medication's price compared with a pair of generic drugs that combine BiDil's two main chemical components. Although she said clinical data have shown BiDil offers greater health benefits and easier dosing than the generics, NitroMed has had a hard time winning over doctors and patients as insurers seek to reduce health care costs.

"I don't think this is an indicator of what is going to happen to personalized medicine," Moussatos said Wednesday. "There were some practical and unique circumstances that have made BiDil unsuccessful commercially."

Lexington, Massachusetts-based NitroMed said it is laying off 70 of its 90 employees, with additional cuts possible in coming months. NitroMed will suspend sales and marketing for BiDil, the company's only product, with remaining employees ensuring that existing patients continue receiving BiDil.

Although BiDil sales grew about nine cent in last year's fourth quarter compared with the third quarter, chief executive Kenneth Bate told analysts on a conference call that NitroMed no longer believes it can realize the drug's potential with its current small marketing and sales forces.

The company hired the investment banking firm Cowen & Co. to advise it on strategic moves.

"Nothing is off the table at this time, and all strategic options are possible," Bate said.

NitroMed continues to develop the once-a-day version of BiDil, and hopes to submit an application to the U.S. Food and Drug Administration in 2010 to market the new formulation.

After BiDil's approval, some analysts projected sales would approach $200 million as soon as 2007. But sales were just $11 million in the first nine months of last year, when the company posted a $24.7 million loss.

Jennifer Chao, a Deutsche Bank analyst, said in a research note the outlook for BiDil "remains extremely uncertain, at least in the near-to-medium term."

If NitroMed finds a buyer, the most likely party would be a large pharmaceutical company with drugs to treat cardiovascular conditions, Moussatos said.

Such a company could give NitroMed the financial resources to pay for advertisements in mass media, rather than the niche publications and medical journals that have been the focus of much of BiDil's marketing so far.

Initial ads stressed quality-of-life issues for black heart-failure patients rather than dwelling on the drug's race-specific status. BiDil representatives also made personal pitches at black churches and health fairs in cities with large black populations, and forged partnerships with groups like the NAACP.


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