INKP Inkine Pharmaceutical (MM)

InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced that seven abstracts with data from clinical studies of the Company's next-generation purgative product, INKP-102, have been accepted for poster presentations at the 70th Annual Scientific Meeting of the American College of Gastroenterology (ACG), to be held from October 28 to November 2, 2005, at the Honolulu Convention Center. The abstracts are based on the results of two randomized, multicenter, investigator-blinded clinical trials comparing various dosing regimens of INKP-102 to 40 Visicol(R) tablets in adults undergoing colonoscopy, including a Phase 2 dose-ranging trial and a Phase 3 pivotal trial. These trials indicate that INKP-102 may have important advantages over Visicol(R) tablets in efficacy, safety, and acceptance by patients. Visicol(R) is the Company's currently marketed sodium phosphate tablet purgative, which is indicated for cleansing of the bowel as a preparation for colonoscopy in adults 18 years of age or older. INKP-102 tablets contain the same active ingredients as Visicol(R), but are smaller in size and easier to swallow. Also, the new tablets contain no microcrystalline cellulose (MCC), an inert, but highly insoluble, tablet binder that is present in Visicol(R). The Company has filed patent applications that, if granted, would protect INKP-102 until 2024. The seven abstracts are authored by a total of 20 academic and community gastroenterologists and colorectal surgeons who were study investigators, as well as by Company scientists. The abstracts present a broad range of data relating to the efficacy, safety and patient acceptance of INKP-102 tablets, including: -- Efficacy results of the Phase 2 dose ranging study, suggesting that several of six tested dosing regimens of INKP-102, including regimens of 28, 32, or 40 tablets, provided colon cleansing at least comparable to or better than marketed Visicol(R) tablets; -- Efficacy results of the Phase 3 pivotal trial, indicating that 32 or 40 INKP-102 tablets provided overall colon cleansing at least comparable to Visicol(R), with significantly better cleansing in the ascending colon; -- Additional efficacy results of the Phase 3 trial, indicating that INKP-102 tablets provided excellent colon cleansing for both morning and afternoon colonoscopy procedures; -- Results from the Phase 3 study indicating that patients found 32 INKP-102 tablets to be easier to take and preferable for a future colonoscopy than 40 Visicol(R) tablets; -- Results from the combined data of the Phase 2 and Phase 3 studies indicating that the safety and efficacy of INKP-102 tablets were similar in patients 65 and older compared to younger patients; -- Safety results from the combined data of the two studies indicating that 32 INKP-102 tablets were associated with a significantly lower rate of adverse events than 40 Visicol(R) tablets; and -- Results from the combined safety database indicating that 32 INKP-102 tablets were associated with a better electrolyte profile than 40 Visicol(R) tablets. The accepted abstracts will be published in an upcoming edition of the American Journal of Gastroenterology. "The upcoming ACG meeting will be the first forum where the gastroenterology community is exposed to the outstanding results of our two completed trials of INKP-102," said Robyn G. Karlstadt, M.D., F.A.C.G., InKine's Vice President for Clinical Operations. "We believe that these studies, conducted in over 1,000 patients, are consistent in demonstrating the excellent colon cleansing of 32 tablets of INKP-102 throughout the colon in adults of all ages, regardless of the time of day the colonoscopy was performed. The studies also indicate that the 32 tablet dose of INKP-102 has a better safety profile than 40 Visicol(R) tablets and is consistently preferred by patients," added Dr. Karlstadt. "The results of our two studies of INKP-102 indicate that we have made a very good purgative, Visicol(R) tablets, even better," stated Martin Rose, M.D., J.D., InKine Executive Vice President for Research and Development. "We believe that the data show that our next generation purgative provides comparable or better colon cleansing than Visicol(R) at a lower total dose of sodium phosphate, with enhanced safety and patient acceptance. We think that physicians who have already switched to Visicol(R) will find that they and their patients will like INKP-102 even more. Those physicians who have tried Visicol(R) and found the MCC residue to be bothersome ought to be very pleased by the improved cleansing of INKP-102, especially in the cecum and ascending colon. All physicians should appreciate the improved safety of the lower dose, and patients will like the smaller tablet," added Dr. Rose. InKine submitted a New Drug Application (NDA) during the second quarter of 2005 for US marketing of INKP-102. The US Food and Drug Administration (FDA) recently informed InKine that the NDA was accepted for filing and will be reviewed. The Company anticipates that the commercial launch of INKP-102 will occur in the first half of 2006. However, there can be no assurance 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 has been 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 developing 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, including the potential benefits of INKP-102, the timing of commercial launch of INKP-102 and expectations of physician and patient acceptance of 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, InKine's ability to commercialize INKP-102 and grow product revenue 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.