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BioDelivery Sciences Announces New Drug Submission in Canada for BEMA Fentanyl
Presents Opportunity to Be the First Oral Transmucosal Fentanyl Product Approved in Canada
Source: BioDelivery Sciences International, Inc.
On Friday October 2, 2009, 8:30 am EDT
Companies: BioDelivery Sciences International Inc.
RALEIGH, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) today announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined.
Symbol Price Change
BDSI 4.93 +0.08
BEMA Fentanyl was submitted to Health Canada by Meda Valeant Pharma Canada Inc. BDSI’s global commercial partner for BEMA Fentanyl, Meda AB, is engaged in a joint venture with Valeant Canada Limited to commercialize BEMA Fentanyl for the management of breakthrough cancer pain in opioid-tolerant patients.
“We are very pleased with the progress that Meda is making in expanding the availability of BEMA Fentanyl,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “We believe Meda’s global presence and commitment to the product are playing an important role in growing the opportunity for BEMA Fentanyl.”
In addition to approval from the U.S. FDA on July 16, 2009, BEMA Fentanyl is currently under regulatory review in the European Union with approval expected in 2010.
Under agreements with BDSI, Meda AB has the worldwide rights to commercialize and market BEMA Fentanyl, except in South Korea and Taiwan, the rights to which remain with BDSI.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI’s pain franchise currently consists of two products utilizing the Company’s patented BEMA buccal soluble film technology: ONSOLIS (fentanyl buccal soluble film) which was approved by FDA on July 16, 2009, for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain, and BEMA Buprenorphine, an analgesic in Phase 2 clinical development with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA technology and its patented Bioral cochleate technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company’s headquarters is located in Raleigh, North Carolina. For more information please visit BioDelivery Sciences International
BDSI®, BEMA® and Bioral® are registered trademarks, and ONSOLISTM is a trademark of BioDelivery Sciences International, Inc.