Acceptance of final Visicol (REG) Phase IV constipation study results for presentation at the American College of Gastroenterology

Main Category: GastroIntestinal / Gastroenterology
Article Date: 27 Jul 2004 - 11:00 PDT


InKine Pharmaceutical Company, Inc (Nasdaq: INKP) today announced that the final results of the Company's Phase IV study of Visicol®'s use in treating patients with constipation will be presented at the 69th Annual Scientific Meeting of the American College of Gastroenterology, to be held in Orlando, Florida from October 31 - November 4, 2004.

"We are pleased that the American College of Gastroenterology has accepted for presentation the results of this important study. Our franchise product, Visicol®, continues to gain acceptance in the colonoscopy marketplace, with a record high of more than 10,000 prescriptions filled during the most recent week based on unaudited IMS data. The results of the Phase IV study of Visicol® for use as a laxative will be important in extending the Visicol® franchise beyond use in preparation for a diagnostic procedure into possible repeated use as a therapeutic agent," said Leonard S. Jacob, M.D., Ph.D, Chairman and Chief Executive Officer of InKine.

"The acceptance of the study results for presentation at this prestigious meeting is an indication of the importance and interest of this potential product extension to the gastroenterology community and its strong commercial potential," said Martin Rose, M.D., J.D., InKine's Executive Vice President for Research and Development.

The study results in patients with functional constipation or constipation predominant Irritable Bowel Syndrome demonstrated 96% to 100% effectiveness in increasing the number of bowel movements per week while significantly reducing the associated symptoms of constipation.

The multicenter study included 40 evaluable patients with chronic constipation, which was defined as three or less bowel movements per week. The patients were randomized to receive daily either a single four tablet dose or an eight tablet regimen, with four tablets dosed twice over 15 minutes. Eight ounces of fluid was given with each dose and the dose could be adjusted based on response at pre-determined time intervals. The treatment period was four weeks with weekly assessments.

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® is the only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat®, is an oral hyoscyamine spray for the treatment of a variety of indications. The Company is also promoting VSL#3®, a probiotic that is effective in treating certain gastrointestinal disorders. Additionally, the Company is developing INKP-102, an advanced generation purgative, which is in Phase II clinical trials for bowel cleansing prior to colonoscopy and Colirest™, which is in clinical trials for the treatment of Crohn's disease. For further information, please visit InKine on its web site http://www.inkine.com.

In addition to historical facts or statement of current condition, this press release and other statements made from time to time by representatives of the Company contain or may contain forward-looking statements. Forward-looking statements provide InKine's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. 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 as well as more specific risks and uncertainties such as those set forth in its 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 does not intend (and it is not obligated) to update publicly any forward-looking statements. This discussion is permitted by the Private Securities Litigation Reform Act of 1995.

Contacts:

Robert Apple, Chief Operating & Financial Officer
InKine Pharmaceutical Company, Inc.
(215) 283-6850

Don Weinberger
Wolfe Axelrod Weinberger Assoc. LLC
(212) 370-4500
don@wolfeaxelrod.com

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