Friday, June 30, 2006

Cephalon Inc. received an approvable letter from the Food and Drug Administration for Fentora, a treatment of breakthrough pain in patients with cancer. Breakthrough pain is a relatively brief but sharp burst of pain that isn't helped by daily pain medication.

The company's shares closed up 11 percent Friday at $60.10.

Fentora is a sugar-free tablet that contains fentanyl, the same active ingredient found in Actiq, Cephalon's cancer pain medicine made as a lozenge attached to a stick that resembles a lollipop.

The FDA issues approvable letters when it wants more information on drugs it believes can be approved.

The FDA indicated in its letter Thursday night that no additional safety or efficacy data for Fentora are required and that the labeling has been essentially finalized.

Cephalon (NASDAQ: CEPH - News) of Frazer, Pa., did not say exactly what information the agency is seeking. The biotechnology company did say it expects to respond to the FDA by the end of July.

"We are pleased with FDA's response and are working closely with the agency to secure final approval of this important new medication," said Dr. Paul Blake, the company's executive vice president of worldwide medical and regulatory operations.

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