INKP Inkine Pharmaceutical (MM)

InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced that on April 29, 2005 the Company submitted an electronic New Drug Application (NDA) for the United States marketing approval of its next generation sodium phosphate tablet, INKP-102. The NDA is based on data from two randomized, multicenter, investigator-blinded clinical trials comparing INKP-102 to 40 Visicol(R) tablets, including a Phase 2 dose-ranging trial and a Phase 3 pivotal trial. Based on the results of these trials, the dose of INKP-102 proposed for marketing is 32 tablets (48 g), compared to the approved dose of 40 tablets (60 g) for Visicol(R) tablets. The clinical trials indicated that the 32 tablet INKP-102 dose was comparable or significantly superior to 40 Visicol(R) tablets in all tested efficacy parameters, and met the primary efficacy endpoint of non-inferiority for the overall colon cleansing response rate in the Phase 3 trial. In the combined safety database, the 32 tablet INKP-102 dose was significantly superior to Visicol(R) tablets in several key safety parameters. In the Phase 3 trial, patient acceptance was significantly greater with INKP-102 compared to patients who took Visicol(R) tablets. Significantly more patients who took 32 INKP-102 tablets indicated that they would be willing to take the same preparation again for a future colonoscopy compared to those who took Visicol(R) tablets. Results in the Phase 2 trial were supportive. "The data in this NDA support our original belief that our new MCC-free sodium phosphate tablet would result in improved colon cleansing compared to currently marketed Visicol(R) tablets," said Martin Rose, M.D., J.D., Executive Vice President for Research and Development at InKine. "In our studies, INKP-102 was given at a lower dose with fewer tablets than Visicol(R). It has a better safety profile and is better accepted by patients," added Dr. Rose. "We are pleased to report that we have submitted our NDA for review by FDA two months ahead of our internal forecasted timeline'" said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executive Officer of InKine. "Based on the improved efficacy, safety and patient acceptance attributes, we believe that INKP-102, if approved by FDA, will be the best purgative on the market and should significantly expand InKine's share of the market for colon cleansing products," added Dr. Jacob. INKP-102 tablets are smaller in size and easier to swallow than the Company's currently marketed sodium phosphate tablet product, Visicol(R). The new INKP-102 tablets contain no microcrystalline cellulose (MCC), an inert, but highly insoluble, tablet binder. The Company has filed a patent application that, if granted, would protect INKP-102 until 2024. There can be no assurance the FDA will accept the NDA for filing or that INKP-102 will receive FDA approval. Without FDA approval, the Company cannot market or sell INKP-102. About InKine Pharmaceutical InKine Pharmaceutical Company, Inc. is a publicly traded specialty pharmaceutical company focused on developing and commercializing pharmaceutical products for the diagnosis and treatment of gastrointestinal disorders. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's franchise product, Visicol(R) is the only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat(R), is an oral hyoscyamine spray for the treatment of a variety of indications. Additionally, the Company is developing INKP-102, an advanced generation purgative, which we recently submitted a new drug application to FDA for bowel cleansing prior to colonoscopy and studying Visicol(R) for use as a laxative in treating patients with chronic constipation. For further information, please visit InKine on its web site http://www.inkine.com. This press release contains forward-looking statements, including statements regarding our expectations regarding INKP-102. Such forward-looking statements are based on InKine's current expectations or forecasts of future events. InKine's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries, market acceptance of product introductions by InKine and its competitors, InKine's success in implementing sales and marketing changes and the effects of the other risks and uncertainties set forth in InKine's reports on Form 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, InKine may elect to update forward-looking statements, but the Company disclaims any obligation to do so.