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  FOR IMMEDIATE RELEASE
Contact:  

Robert F. Apple, Chief Operating Officer
InKine Pharmaceutical Company, Inc.
215-283-6850

Donald C. Weinberger
Wolfe Axelrod Weinberger Assoc. LLC
212-370-4500,
[email protected]


 INKINE COMPLETES ENROLLMENT IN INKP-102 PHASE III COLONOSCOPY STUDY AND ANNOUNCES INTENT TO RETURN COLIREST LICENSE

 

BLUE BELL, PA December 8, 2004 -- InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the completion of enrollment of patients in a Phase III colonoscopy study of the Company’s advanced generation sodium phosphate purgative tablet, INKP-102. This study is a multicenter, investigator-blinded, 3-arm trial comparing dosing regimens of 32 and 40 tablets of INKP-102 against the Company’s currently marketed Visicol® at the labeled dose of 40 tablets in adults scheduled for colonoscopy. Both of the INKP-102 dosing regimens in the study utilize a more convenient dosing schedule than currently labeled for Visicol®. The study examined the efficacy, safety and patient acceptance of INKP-102, and in approximately nine weeks enrolled about 700 patients undergoing a colonoscopy.  Results of this study are expected to be available by the end of the first quarter of 2005.

 “This study enrolled faster than we expected,” said Martin Rose, M.D., J.D., InKine’s Executive Vice President for Research and Development.  “Our previously completed Phase II study suggested that INKP-102 was well-tolerated and provided excellent colon cleansing at a dose of either 32 or 40 tablets. We hope to confirm these findings in the Phase III study,” added Dr. Rose.

 FDA previously reviewed the Phase III study protocol under the Agency’s “Special Protocol Assessment” procedure, and indicated to InKine that this single Phase III study together with a single Phase II study (which was recently completed) could support NDA approval of INKP-102. INKP-102 tablets are smaller than Visicol® tablets and contain no microcrystalline cellulose, an inert but highly insoluble substance in Visicol® tablets. InKine has filed a provisional patent application with the U.S. Patent and Trademark Office, which, if granted, would protect INKP-102 until 2024.

 “Our currently marketed purgative product, Visicol®, continues to reach record levels in terms of market share and prescriptions,” said Leonard S. Jacob, M.D., Ph.D., InKine’s Chairman and Chief Executive Officer.  “The introduction of INKP-102 to the marketplace for use prior to colonoscopy will provide gastroenterologists with what we believe will be the ultimate tablet purgative and could provide InKine with a longer patent life,” added Dr. Jacob.

In other news, the Company today announced that it intends to return its Colirestä patent license to the Licensor.  Preliminary analysis of interim efficacy data from 65 patients in a Phase IIb Crohn’s disease study demonstrated a numerical trend favoring high dose therapy over placebo, but not to the extent that the Company believes would warrant the additional costs associated with seeking a marketing partner to further the development of Colirestä.

Dr. Jacob stated “despite the interesting science behind the development of Colirestä in treating patients with Crohn’s disease, as previously disclosed, we would seek a marketing partner only if the data were positive.”  Dr. Jacob added, “Our development efforts will continue to focus on the commercialization of INKP-102 and the further development of Visicol in treating patients with constipation.”

 

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® 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 recently completed Phase II clinical trials for bowel cleansing prior to colonoscopy, Visicol® for use as a laxative in treating patients with constipation. 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 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.