Adolor Corp (ADLR)

[surf1944]

UPDATE 1-US FDA says Roche, Sanofi promotions misleading
Fri Apr 23, 2010 12:04pm EDTStocks
Roche Holding AG

* Agency objects to cancer, HIV, bowel drug promotions

* Complaints cite consumer video, sales rep statements

WASHINGTON, April 23 (Reuters) - Roche Holding AG (ROG.VX), Sanofi-Aventis (SASY.PA) and Adolor Corp (ADLR.O) made misleading claims about cancer, HIV and bowel drugs, U.S. regulators said in letters released on Friday.

The Food and Drug Administration objected to a video for consumers from Roche unit Genentech about cancer drug Herceptin. The video "minimizes the serious risks associated with the use of Herceptin and presents misleading claims regarding the benefits," the FDA said in March 26 letter to the company.

In a separate April 6 letter, the FDA said three Roche sales materials made misleading claims about HIV drug Invirase.

The agency also said an Adolor sales representative had minimized the risks of bowel drug Entereg and overstated effectiveness in comments made at a December 2009 pharmacists' meeting. The letter to Adolor was dated April 21.

With Sanofi, the FDA said in an April 20 letter that one of the company's promotions made unsupported claims about prostate cancer drug Eligard.

Officials at the companies could not immediately be reached for comment. (Reporting by Lisa Richwine; Editing by Lisa Von Ahn)