The initial focus of the agreement will be Fentora, which received FDA 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 usually accepts registration of pharmaceuticals previously approved in the US on the basis of a single trial conducted in China. Beijing Med-Pharm will design and conduct a Chinese registration trial for Fentora, with the application process beginning in 2007.
“Beijing Med-Pharm has developed contacts in the oncology community in China and a full suite of capabilities for investigating and registering Western medicines in this significant and rapidly growing market.
“We intend for our collaboration on Fentora to be the first in a successful partnership with Beijing Med-Pharm that will facilitate the incorporation of Cephalon products into medical care in China,” stated Robert Roche Jr, executive vice president, Worldwide Pharmaceutical Operations at Cephalon.