Healthcare Industry News: fentanyl buccal tablet
News Release - December 11, 2006
Beijing Med-Pharm Corporation Enters Into an Agreement to Develop and Register Products for Cephalon, Inc. in ChinaPLYMOUTH MEETING, Pa.--(HSMN NewsFeed)--Beijing Med-Pharm Corporation (Nasdaq: BJGP ) announced today that it has entered into a master services agreement with Cephalon, Inc. (Nasdaq: CEPH ) under which Beijing Med-Pharm will complete the clinical development and registration process for certain Cephalon products in the People's Republic of China.
The initial focus of the agreement will be FENTORA(TM) (fentanyl buccal tablet), which received U.S. 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 United States on the basis of a single clinical trial conducted in China. Beijing Med-Pharm will design and conduct a Chinese registration trial for Fentora, with the application process beginning in 2007.
"We are very pleased that Cephalon has selected Beijing Med-Pharm to be their strategic partner as they seek to introduce their portfolio of medicines in China," said David Gao, Chief Executive Officer of Beijing Med-Pharm. "FENTORA would be a welcome addition to options available to cancer patients in China for managing pain and is an excellent fit with our therapeutic expertise both clinically and commercially."
Robert P. Roche, Jr., Executive Vice President, Worldwide Pharmaceutical Operations at Cephalon, said, "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."
About Beijing Med-Pharm Corporation
Beijing Med-Pharm is a pharmaceutical marketing and distribution company that offers the following services in China: pre-market entry analysis; clinical trial management; product registration; market research; pharmaceutical distribution to hospitals; and pharmaceutical marketing to physicians, hospitals and other healthcare providers.
FENTORA is the first tablet formulation of the opioid fentanyl and the first new medication approved for the management of breakthrough pain in opioid-tolerant patients with cancer since 1998. Its proprietary OraVescent® drug delivery system was developed by Cephalon subsidiary CIMA LABS.
In clinical trials, FENTORA was generally well tolerated. Most adverse events occurring with FENTORA are typical opioid side effects. The most serious adverse events associated with all opioids are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. All patients should be followed for symptoms of respiratory depression. Opioid side effects should be expected and managed accordingly. The most common (greater than or equal to 10%) adverse events observed in clinical trials of FENTORA were nausea, vomiting, application site abnormalities, fatigue, anemia, dizziness, constipation, edema, asthenia, dehydration, and headache. Most side effects were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.
Forward Looking Statements
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding our expectations to complete the clinical development and registration process for FENTORA in China, our expectations to design and conduct a Chinese registration trial for FENTORA, with the application process beginning in 2007, our expectation that FENTORA will be a welcome addition to options available to cancer patients in China for managing pain, and our collaboration with Cephalon. Forward-looking statements provide Beijing Med-Pharm's current expectations or forecasts of future events. Actual results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and the Chinese pharmaceutical market, and due to risks and uncertainties associated with the clinical development, registration and potential for market acceptance of FENTORA in China. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Beijing Med-Pharm undertakes no obligation to update publicly any forward-looking statement.
Source: Beijing Med-Pharm
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