The vote by a U.S. Food and Drug Administration panel on Tuesday to not recommend expanding the use of Cephalon Inc's Fentora pain drug will have no impact on 2008 earnings, its chief executive said on Tuesday.
CEO Frank Baldino said the vote was a disappointment, but not surprising. "It could have gone either way," he said on a conference call.
He said Cephalon will be in discussions with the FDA over how to move forward with the drug, which the company wants to sell for use in people without cancer who have sudden flare-ups of chronic pain and are already taking opioid medications all the time. The drug is already approved for such breakthrough pain in cancer patients.
Cephalon said it is about halfway through enrollment in a study comparing Fentora directly to pain drug OxyContin.
Cephalon, Inc. is a U.S. biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr., a pharmacologist and former scientist with the DuPont Company, who continues to serve as its chairman and chief executive officer. The company's name relates to the Greek root word "cephalic" meaning "related to the head or brain," and it was established primarily to pursue treatments for neurodegenerative diseases.
Cephalon is a component of the S&P MidCap 400 stock index, and is included in the Fortune 1000 list of U.S. companies based upon annual revenues for 2006.