BDSI Announces Purchase of Non-U.S. BEMA(TM) Technology from QLT USA, Inc.; Transaction Eliminates Non-U.S. License and Future Milestone and Royalty Obligations To QLT And Provides Option for Purchase Of U.S. Asset.MORRISVILLE, N.C. -- 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 BDSI Brooks Divinity School, Inc (Denver, CO) ), a specialty biopharmaceutical company focused on acute care products, including pain therapies has purchased from QLT QLT Quadra Logic Technologies QLT Quick Link Text USA, Inc. ("QLT USA"), a subsidiary of QLT Inc. (NASDAQ:QLTI; TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :QLT) all of the non-U.S. rights to the BEMA(TM) drug delivery technology, including all patent rights and related intellectual property. Prior to this transaction, BDSI had licensed BEMA(TM) from QLT USA on a worldwide, exclusive basis. Besides the rights to the BEMA(TM) technology outside of the U.S., the agreement gives BDSI an option to purchase the U.S. BEMA(TM) technology patents within 12 months. E[acute accent acute accent n. A mark (´) indicating: a. that a vowel is close or tense, as é in French été. b. that a vowel or syllable has a high or rising pitch, as in Chinese or Ancient Greek. c. ]The aggregate purchase price for the non-U.S. portion of the BEMA(TM) technology is $3 million, to be paid over time as follows: (1) $1 million was paid at closing, (2) $1 million by the end of first quarter 2007 and, (3) $1 million to be paid within 30 days of 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. approval of the first non-U.S. BEMA(TM)-related product. As part of the transaction as it relates to the non-U.S. portion of the former QLT USA/BDSI license, no further milestone payments or ongoing royalties will be due to QLT USA. In addition BDSI will have the option to purchase the remaining U.S. asset for $7 million dollars. These payments will also be paid over time. E[acute accent]Dr. Mark A. Sirgo, President and 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. of BDSI, said: "This is an exciting, timely and opportunistic transaction for BDSI. The progress we are making with our 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 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 and our experience in working with the technology over the past several years has made the opportunity to create a portfolio of products utilizing this technology even more apparent to us. From a financial perspective, in eliminating the non-U.S. milestone payments and tiered royalties owed to QLT USA, this transaction would be additive to our potential future profitability from product sales, not only from the initial BEMA(TM) Fentanyl product, but all additional BEMA(TM) products we expect to develop outside the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The elimination of the license and long-term royalty obligation to QLT USA, as well as the elimination of QLT USA's approval rights, also places us in a significantly more flexible position to partner with and license to third parties outside the U.S. where we see fit, and to potentially do so on more favorable financial terms to BDSI. As BDSI continues to execute its business plan both the short and long-term financial benefits of this asset purchase, along with the option to purchase the U.S. rights to the technology, will become even more evident." E[acute accent]BEMA(TM) is an acronym for "Bioerodible Mucoadhesive", and consists of a patented oral BEMA(TM) disc, which delivers the drug through the mucosal surface (inner cheek) by placing the disc between the cheek and gum. BDSI, in its merger with Arius Pharmaceuticals in August 2004, acquired the world-wide license to the BEMA(TM) technology, and has since been working to develop and commercialize the technology, most notably with its flagship product A primary product of a company, which is typically why the company was founded and/or what made it well known. For example, MS-DOS, Windows and the Microsoft Office suite have been flagship products of Microsoft. CorelDRAW is a flagship product of Corel Corporation. , BEMA(TM)Fentanyl, which is now in Phase III for the treatment of "breakthrough" cancer pain. The initial BEMA(TM) license was between Arius and Atrix Laboratories, Inc. (now QLT USA, Inc.). E[acute accent]BDSI has estimated annual peak U.S. sales for its first two products being developed in the pain category, BEMA(TM) Fentanyl and BEMA(TM) LA, at $250 million and $500 million, respectively. E[acute accent]About BioDelivery Sciences International E[acute accent]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 owned and licensed 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. 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, 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 are 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. E[acute accent]About QLT Inc. E[acute accent]QLT Inc. (NASDAQ:QLTI; TSX:QLT) is a global biopharmaceutical company specializing in developing treatments for eye diseases as well as dermatological dermatological, dermatologic pertaining to dermatology; of or affecting the skin. and urological conditions. Together with our subsidiaries, we have combined our expertise in the discovery, development and commercialization of innovative drug therapies with our two unique technology platforms, photodynamic therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. and Atrigel(R), to create products such as Visudyne(R) and Eligard(R). For more information, visit our web site at www.qltinc.com. E[acute accent]Forward-Looking Statements E[acute accent]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 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 sales 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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