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Cephalon's EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer Pain
Date:1/24/2008

FRAZER, Pa. and MAISONS-ALFORT, France, Jan. 24 /PRNewswire-FirstCall/ -- Cephalon, Inc., (Nasdaq: CEPH) announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion regarding EFFENTORA(TM), the company's fentanyl buccal tablet pain medication. In March 2007, Cephalon submitted the EFFENTORA European new drug application for the treatment of breakthrough pain in adult cancer patients who are already receiving maintenance opioid therapy for chronic cancer pain. The CHMP recommendation for EFFENTORA will now be forwarded to the European Commission for final marketing approval, which typically occurs within 60 to 90 days.

"We believe this product, once approved, will be an exciting addition to our European product portfolio and will provide a tremendous benefit to patients suffering from breakthrough cancer pain," said Alain Aragues, President Cephalon Europe. "Cephalon is committed to bringing innovative medications to the European market and we are delighted to receive this positive opinion for EFFENTORA from the CHMP."

The prevalence of cancer in Europe is estimated at approximately 2.9 million patients according to the most recent report from GLOBOCAN, a worldwide database of cancer statistics. A large majority of these patients will experience breakthrough cancer pain, a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent chronic pain. Patients experience intense transient flares of pain that interrupt, or "break through," their background persistent pain. Breakthrough pain is characterized by its rapid onset, moderate-to-severe intensity and a relatively short duration. In cancer, the onset
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SOURCE Cephalon, Inc.
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