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Treatment for Pain

Cephalon Files New Drug Application for OraVescent Fentanyl for the Management of Breakthrough Pain in Cancer Patients

FRAZER, Pa., September 6, 2005 -- Cephalon, Inc. announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a fentanyl effervescent buccal tablet for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent pain.

The tablet delivers the opioid fentanyl through the oral mucosa utilizing a proprietary enhanced absorption technology, OraVescent, developed by CIMA Labs Inc., a wholly-owned subsidiary of Cephalon. Upon approval, Cephalon intends to commercialize OraVescent fentanyl (OVF) in multiple dosage strengths (100, 200, 400, 600, and 800 micrograms). The medication will be listed as a Schedule II controlled substance.

"Expanding our pain care franchise is integral to Cephalon's growth strategy," said Dr. Paul Blake, Executive Vice President, Worldwide Medical & Regulatory Operations. "With OVF, we build on our expertise in breakthrough pain to bring innovation to a clinically important, but often inadequately managed, component of chronic pain."

This NDA, submitted on schedule, is the fourth of five new product opportunities that Cephalon is pursuing over a 15-month period. A supplemental New Drug Application (sNDA) for Attenace (modafinil) Tablets [C-IV], for the treatment of attention-deficit / hyperactivity disorder in children and adolescents, and an NDA for Nuvigil (armodafinil) Tablets [C- IV], for excessive sleepiness, were submitted for FDA review in December 2004 and March 2005, respectively. Cephalon recently entered into an agreement to develop and commercialize naltrexone long-acting injection for the treatment of alcohol dependence with Alkermes, Inc., which submitted an NDA for the product in March 2005. Cephalon also is conducting a Phase 3 clinical trial of Gabitril (tiagabine hydrochloride) as a treatment for generalized anxiety disorder.

The NDA submitted for OVF includes results from 13 studies. The pivotal double-blind, placebo-controlled, variable-dose study assessed the safety and efficacy of OVF compared with placebo in opioid-tolerant cancer patients with breakthrough pain. Patients treated with OVF showed a statistically significant improvement on the primary endpoint, the Sum of Pain Intensity Differences through 30 minutes (SPID30) (p <0.01). Interim safety analyses from three on-going Phase 3 trials in opioid-tolerant patients as well as pharmacokinetic data from nine clinical pharmacology studies are included in the submission. Safety data from 360 patients participating in the Phase 3 studies demonstrated that OVF was generally well tolerated.

Cephalon has drawn on its experience with Actiq (oral transmucosal fentanyl citrate) [C-II] to develop a comprehensive Risk Minimization Action Plan (RiskMAP) for OVF, which was submitted with the NDA. FDA considers RiskMAPs integral to the commercialization and safe use of opioids.

About Breakthrough Pain in Cancer Patients

Pain is a primary symptom reported by cancer patients. Of those taking chronic opioid medication for their persistent pain, an estimated 64 to 86 percent experience breakthrough cancer pain. Breakthrough pain is a sudden flare of pain that "breaks through" the relief provided by the pain medication taken around-the-clock to treat underlying persistent pain. The typical episode in cancer patients may peak in as little as three to five minutes, with up to four flares a day. Flares of breakthrough pain are typically severe in intensity and may be excruciating. They often come on suddenly or may be related to a specific activity ("incident pain"). Breakthrough pain can be caused by the cancer itself, treatment, or other cancer-related conditions.

Source: Cephalon, Inc.

Posted: September 2005

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