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Biotech / Medical : CEPH - CEPHALON

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To: Icebrg who wrote (79)	12/10/2003 2:07:56 PM
From: Icebrg	Read Replies (1) of 109

CIMA LABS Announces Successful End of Phase II Meeting with the U.S. Food and Drug Administration on Oravescent Fentanyl Wednesday December 10, 1:51 pm ET Company Finalizing Protocols for Phase III Safety and Efficacy Study EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Dec. 10, 2003-- CIMA LABS INC. (NASDAQ: CIMA - News) today announced that it held its End of Phase II meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's proprietary OraVescent Fentanyl transmucosal dosage form under development for the treatment of breakthrough cancer pain. Following this discussion with the FDA, CIMA expects to begin clinical trial activities in early 2004, with enrollment scheduled to begin in the second quarter of 2004. CIMA is not planning to conduct carcinogenicity studies. Steven Ratoff, CIMA's chairman and interim chief executive officer, commented: "We look forward to beginning our OraVescent Fentanyl Phase III clinical trials. This will be an important advance for CIMA as we work toward commercially launching the Company's first proprietary product."

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