Cubist pulls Web page after warning by FDA

Cubist Pharmaceuticals Inc. of Lexington said yesterday it took down a Web page promoting its flagship antibacterial drug after federal regulators told the company the site contained misleading information.

In a warning letter posted yesterday on its own website, the Food and Drug Administration also said a Cubist advertisement that ran in medical journals failed to include important risk information about the drug. The company said it is withdrawing the ads from future publication.

News of the FDA's warning letter comes a few weeks after Cubist told investors that the Securities and Exchange Commission is investigating whether it disclosed the results of a drug trial in a timely manner. The company says it is cooperating in the investigation.

In a telephone interview, Cubist chief executive Michael W. Bonney said the company will comply with the FDA's requirements, and that the warning won't affect its financial guidance.

Bonney said the print ads were based on other promotional material the FDA previously had approved. ''We were a bit surprised, given that the agency has had the materials they objected to since early April," he said. A spokeswoman for the agency didn't return a message seeking a response.

Cubist's Cubicin is an injectable version of a drug meant to treat complex skin infections, based on the drug daptomycin that Cubist licensed from Eli Lilly and Co. in 1997. Launched last year as the company's first commercial product, Cubicin helped bring in $19.5 million in revenue through June 30.

But according to the FDA, one example of faulty promotion on Cubist's website came when the company claimed Cubicin was proven clinically successful against two types of staphylococcus, a bacteria found on the skin than can cause infections in wounds.

The agency said this description blurred the distinction between some types of staphylococcus infections that are susceptible to daptomycin and those that are not. The lack of detail, the agency said, ''poses a significant public health risk because such practice could lead to therapeutic failure and death."

The agency's letter did not mention any deaths or injuries that have been reported in patients as a result.

As of yesterday afternoon the website carried a message that it is ''undergoing re-construction. Please check back later. Thank you."

Ross Kerber can be reached at kerber@globe.com.