Beijing Med-Pharm Corp has entered into a master services agreement with fellow USA-based biotechnology firm Cephalon, under which it will complete the clinical development and registration process for certain of the latter's products in the People's Republic of China.
The initial focus of the agreement will be Fentora (fentanyl buccal tablet), which received US Food and Drug Administration approval in September 2006, for the management of breakthrough pain in patients with cancer who are already receiving and are tolerant to opioid therapy. The Chinese State Food and Drug Administration (SFDA) usually accepts registration of pharmaceuticals previously approved in the USA on the basis of a single clinical trial conducted in China. Beijing Med-Pharm says it will design and conduct a Chinese registration trial for Fentora, with the application process beginning in 2007.
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