BioDelivery Sciences International and MEDA AB Announce European Licensing Agreement on BEMA(TM) Fentanyl.MORRISVILLE, N.C. & SOLNA, Sweden -- BDSI BDSI Brooks Divinity School, Inc (Denver, CO) To Receive $2.5 Million Upfront License Fee, up to an Additional $7.5 Million Based upon Achieving Milestones and a Double Digit Noun 1. double digit - a two-digit integer; from 10 to 99 integer, whole number - any of the natural numbers (positive or negative) or zero; "an integer is a number that is not a fraction" Royalty on Sales BioDelivery Sciences International, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BDSI), a specialty biopharmaceutical company focused on acute care products, including pain therapies, and Meda AB (OMX OMX Office Max (stock symbol) Stockholm: MEDA A), a leading European specialty pharmaceutical company, announced today a collaboration to develop and commercialize BDSI's flagship BEMA(TM) Fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and product in Europe. BEMA(TM) Fentanyl is a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA product being developed by BDSI for the treatment of "breakthrough" cancer pain. Under terms of the agreement, BDSI will grant Meda rights to the European development and commercialization of BEMA(TM) Fentanyl, in exchange for an upfront fee to BDSI, certain milestone payments, and double digit royalties to be received by BDSI on product sales. Payments include a $2.5 million payment upon execution of the agreement and additional milestones that would, if achieved, provide BDSI with up to an additional aggregate of $7.5 million in revenue. Meda will manage the clinical development and regulatory submissions in all of Europe. Upon regulatory approval, Meda will exclusively commercialize BEMA(TM) Fentanyl in Europe. BDSI shall retain all development and commercial rights in the U.S., Japan, Australia and other territories outside of Europe. "Breakthrough pain is an increasing problem in, for example, cancer care," says Anders Lonner, Meda's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The European market for products that contain fentanyl is rapidly increasing. We have chosen the BEMA(TM) technology because we believe it has the potential to offer important patient benefits compared to competing products. We believe that our pan-European market coverage and expertise in the pain therapy area will give Meda a competitive edge in its BEMA(TM) Fentanyl efforts." "Our attraction to Meda from the outset was their focus in pain with such products as Zamadol (tramadol) and Relifex (nabumetone), their aggressive approach to the pain marketplace and their broad sales coverage in Europe," said Dr. Mark Sirgo, President and CEO of BDSI. "It is expected that Meda will use its expertise in pain management to participate in an estimated total market of over 1.3 million patients in Europe who suffer from cancer pain, of which a significant percentage experience breakthrough episodes. We believe this transaction and agreement represents another important validation of the BEMA(TM) technology and the value behind the BEMA(TM) Fentanyl product specifically. This agreement also represents another in a series of milestones for BDSI articulated as mission-critical goals for our company. By providing for future revenue potential from Meda and by eliminating royalties owed to QLT QLT Quadra Logic Technologies QLT Quick Link Text through our recent acquisition of the non-U.S. BEMA(TM) technology asset, we believe these transactions have the potential to reap material financial benefits for BDSI in the future." About Meda AB Meda is a leading European specialty pharma company that concentrates on marketing and market-adapted product development. Acquisitions and long-term partnerships are fundamental factors that drive the company's strategy. Meda is represented in more than 20 countries and has about 900 employees within marketing and sales. Meda's shares are quoted on the Stockholm stock exchange The Stockholm Stock Exchange (Swedish: Stockholmsbörsen) is a stock exchange located in Stockholm, Sweden. Founded in 1863 [1] it is the primary securities exchange of the Nordic Countries. (Stockholmsborsen). Find out more, visit www.meda.se. About BioDelivery Sciences International BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its licensed and patented drug delivery technologies to develop and commercialize clinically-significant new products using proven therapeutics. BDSI's pain franchise currently consists of two products in development utilizing the company's patented BEMA(TM) oral adhesive disc technology: BEMA(TM) Fentanyl, a treatment for "breakthrough" cancer pain which is expected to complete its Phase III BEMA Fentanyl trials during the second half of 2006, and BEMA(TM) LA, a second analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs with a target indication of the treatment of moderate to severe pain, which is currently in Phase I trials and on which the company intends to initiate Phase III trials in the second half of 2006. BDSI's pain franchise opportunity with BEMA(TM) Fentanyl and BEMA LA is projected at $250 million and $500 million in annual revenue potential, respectively. The company is also working with both its BEMA(TM) technology and its patented Bioral(R) nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia insomnia, abnormal wakefulness or inability to sleep. The condition may result from illness or physical discomfort, or it may be caused by stimulants such as coffee or drugs. However, frequently some psychological factor, such as worry or tension, is the cause. , nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. , and infections. The company's headquarters is located in Morrisville, North Carolina Morrisville is a town in Wake County, North Carolina, USA. The population was 5,208 at the 2000 census. A Special Census was conducted by the United States Census Bureau in March 2004, when the population was enumerated at 11,915. and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, that involve risks and uncertainties. Such statements may include, without limitation, statements with respect to the plans, objectives, expectations and intentions and other statements of BioDelivery Sciences International, Inc. and other parties, which statements are identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the results of scheduled or additional clinical trials and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or foreign regulatory review of the Company's formulations and products may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). Peak patient coverage estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all. |
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