Beijing Med-Pharm will help Cephalon introduce its products in China. Beijing Med-Pharm will undertake clinical development and the registration process. The initial focus of the agreement will be Fentora™, which was approved 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 accepts registration of U.S.-approved pharmaceuticals after one clinical trial is conducted in China. Beijing Med-Pharm will thus design and conduct a Chinese registration trial for Fentora. The companies expect the application process to commence 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,” says Robert P. Roche, executive vp, worldwide pharmaceutical operations at Cephalon. “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."