Agreement with Aveva Drug Delivery Systems a Key Milestone as BDSI Enters Phase III Trial.
MORRISVILLE, N.C.–(BUSINESS WIRE)– Nov. 8, 2005– BioDelivery Sciences International, Inc. (NASDAQ: BDSI – News, BDSIW – News), a specialty pharmaceutical company, today announced that it has entered into a supply agreement with Aveva Drug Delivery Systems, Inc. (Aveva) under which Aveva will prepare clinical supplies for BDSI’s Phase III trials and provide commercial manufacturing for BEMA(TM) Fentanyl. BDSI’s BEMA(TM) Fentanyl is an oral adhesive disc formulation of the narcotic fentanyl. BDSI has been and expects to continue its production ramp-up of the clinical trial materials for Phase III BEMA(TM) Fentanyl trials during the fourth quarter of 2005. BDSI plans on completing its Phase III program during the second half of 2006 for the treatment of “breakthrough” cancer pain (i.e., episodes of severe pain which “breakthrough” the medication used to control the persistent pain). In related BEMA(TM) Fentanyl news, BDSI recently reported positive results in a pharmacokinetic study comparing BEMA(TM) Fentanyl and Actiq®, a lozenge formulation of fentanyl which is the current market leader in fast dissolving fentanyl products in treating breakthrough cancer pain. In this trial, BEMA(TM) Fentanyl enabled greater bioavailability (absorption), higher maximum plasma concentrations (Cmax) and faster concentrations of fentanyl in the plasma (t-first and t-max) compared to Actiq®. Actiq®, made by Cephalon Inc. (NASDAQ:CEPH – News), is considered the market leader in breakthrough cancer pain treatment with projected 2005 sales, based on Cephalon’s public statements, between $410 and $420 million.
Dr. Mark Sirgo, President and CEO of BDSI, stated “We are very pleased to be able to work with Aveva toward the production of the BEMA(TM) Fentanyl product. The entry into this agreement represents the fulfillment of a key component of our BEMA(TM) Fentanyl strategy. With this agreement in place, we are well positioned for manufacturing of the Phase III program supplies and, if FDA approval is obtained, the ultimate commercial launch of BEMA(TM) Fentanyl.”
Dr Andrew Finn, BDSI’s Executive Vice President of Clinical and Regulatory Affairs, added “In our recent pharmacokinetic study, we experienced excellent results with large production batches of BEMA(TM) Fentanyl manufactured at Aveva. We believe Aveva’s capabilities will, at the appropriate time, allow us to move into commercial scale very quickly.”
Wallace K. Reams, President and Chief Operating Officer of Aveva, stated “We are pleased to bring Aveva’s depth of experience in transdermal and transmucosal drug delivery systems to the BEMA(TM) Fentanyl program. Our arrangement with BDSI further demonstrates our commitment to add value to our partners.”
Under the terms of the supply agreement, Aveva, of Miramar, Florida, will have the exclusive right to manufacture and supply the BEMA(TM) Fentanyl discs to BDSI, which will, either alone or in partnerships with other third parties, market, sell and distribute the product within North America.
Aveva Drug Delivery Systems, Inc. is a Nitto Denko company, which is one of the world’s largest manufacturers of and a pioneer in transdermal drug delivery systems. Nitto Denko has a 20-year history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or are high-quality, low-cost brand equivalents. Leveraging this experience, Aveva offers a full range of research, development and manufacturing capabilities using a number of sophisticated technologies to produce proprietary and generic transdermal drug delivery systems that fortify research and development pipelines and maximize the life cycles of products.
BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at “acute” treatment opportunities such as pain, anxiety, nausea and vomiting and infections. The company’s drug delivery technologies include: (i) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company’s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey.