Connetics Corporation (CNCT) Receives FDA Non-Approvable Letter For Velac; Shares Plunge
10/19/2005 5:08:54 PM
PALO ALTO, Calif.--(BUSINESS WIRE)--June 13, 2005--Connetics Corporation (Nasdaq:CNCT), a specialty pharmaceutical company focused on dermatology, announced today that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter dated June 10, 2005 for Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin) Gel, an investigational new drug formulation for treating acne. The only issue raised in the non-approvable letter was a positive carcinogenicity signal that was detected in a TgAC mouse dermal carcinogenicity study.
"We are disappointed in the FDA's decision. As discussed during our first quarter earnings call on April 26, we were particularly disappointed that FDA did not notify us of this as a potential issue until two months prior to the PDUFA date," said Thomas G. Wiggans, chief executive officer of Connetics. "We remain committed to bringing Velac to market, and will be working with FDA representatives to determine what is required to do so. Despite this setback, Connetics will continue to expand its leading position in the dermatology field with four brands on the market and a robust and diverse pipeline."