Cardinal Health to Manufacture Ibuprofen Tablets for Use by SCOLR, Inc. in Its Human Trials.BELLEVUE, Wash. -- SCOLR, Inc. (AMEX AMEX See: American Stock Exchange :DDD DDD Direct Distance Dialing DDD Digital/Digital/Digital (audio CD format, recording/mixing/mastering) DDD Degenerative Disc Disease DDD Domain Driven Design DDD Data Display Debugger (GNU Project) ) announced today that it had entered into an agreement with Cardinal Health <includeonly></includeonly> Cardinal Health (NYSE: CAH) is a premier, global healthcare company dedicated to making healthcare safer and more productive. Overview Headquartered in Dublin, Ohio, Cardinal Health, Inc. , Inc. for the manufacture of the extended release 12-hour Ibuprofen ibuprofen (ī`by prō'fən), nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation. tablets to be used in SCOLR's pending human clinical evaluations. Under the agreement, the initial clinical batches of CDT CDTabbr. Central Daylight Time CDT Central Daylight Time CDT n abbr (US) (= Central Daylight Time) → hora de verano del centro; (BRIT (R) Ibuprofen will be manufactured at the Cardinal Health facility located in Somerset, N.J. "Now that we have secured a world-class, quality commercial manufacturer for our CDT Ibuprofen tablets, we look forward to the commencement of our initial human testing at a Canadian research facility in early September," said Daniel O. Wilds, 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 SCOLR, Inc. "The purpose of our initial study is to allow us to make any necessary formulation and clinical design refinements ahead of the larger scale human study needed for U.S. regulatory approval. Our initial human study should take approximately four to six weeks, and after completing a thorough data evaluation, we anticipate filing an Investigational New Drug Application (IND) with the United States 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. seeking permission to begin the larger U.S. human study needed for product approval. The FDA requires a minimum 30-day waiting period from the time of that filing and the beginning of the human testing. Hence, we anticipate initiating our extended release Ibuprofen trial to support U.S. regulatory approval in late 2004 or early 2005," Wilds said. "Assuming a successful outcome of that study, we plan to file a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) with the FDA in the summer of 2005. That FDA review process typically takes between 18 to 24 months. Based on preliminary discussions with multiple interested parties, we understand that availability of human testing data for our 12-hour extended release product formulation is a key element in the decision making process of any potential licensing partner. We expect to continue discussions with potential licensing and/or distribution partners as the clinical evaluation and U.S. regulatory approval process progresses associated with our bringing the first extended release, 12-hour Ibuprofen to the U.S. market. "Every step taken toward the ultimate commercialization of a CDT formulation is an important, value-driving milestone for SCOLR," Wilds added. "Ibuprofen is the first of four identified targets for internal development at this time. We look forward to advancing the work on and initiating clinical evaluations, where required, for our other development targets, including Pseudoephedrine pseudoephedrine /pseu·do·ephed·rine/ (-e-fed´rin) one of the optical isomers of ephedrine; used as the hydrochloride or sulfate salt as a nasal decongestant. pseu·do·e·phed·rine n. , Tramadol and Niacin niacin: see coenzyme; vitamin. niacin or nicotinic acid or vitamin B3 Water-soluble vitamin of the vitamin B complex, essential to growth and health in animals, including humans. in 2005, parallel with our development of Ibuprofen." Based in Bellevue, Wash., SCOLR, Inc. is a specialty pharmaceutical company leveraging formulation expertise and its patented CDT(R) platform to introduce distinctive and novel OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). products, prescription drugs and dietary supplements. SCOLR's CDT drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. For more information on SCOLR, please call 425-373-0171 or visit http://www.SCOLR.com/. This press release contains forward-looking statements (statements which are not historical facts) 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. These forward-looking statements involve risks and uncertainties, including activities, events or developments that the company expects, believes or anticipates will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including the Company's ability to continue to successfully develop new formulations, initiate and complete successful human studies and clinical trials, obtain regulatory approval, to market and to provide its products and services and maintain their effectiveness, the continuation of arrangements with the Company's product development partners and customers, competition, government regulation, and general economic conditions. Such statements are subject to a number of assumptions, risks and uncertainties which are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. Readers are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances. |
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