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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, 212-370-4505 fax
[email protected]


INKINE COMPLETES ENROLLMENT IN PHASE 2 STUDY OF NEXT GENERATION PURGATIVE PRODUCT – INKP-102

 

BLUE BELL, PA May 12, 2004 -- InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the completion of enrollment in the Company’s multicenter Phase 2 study of its next generation sodium phosphate tablet, INKP-102.  The randomized, investigator blinded Phase 2 study included approximately 210 adult patients undergoing colonoscopy, and compared six dosing regimens of the new formulation against Visicol tablets.  Some of the new formulation arms involved a reduced tablet dose and dosing that is completed the evening before the colonoscopy, changes intended to further enhance patient satisfaction with the tablets.  Results from this study are expected in the third quarter of 2004.  The new tablets are smaller than current Visicol tablets, the Company’s sodium phosphate tablet that is indicated for colon cleansing in adults prior to colonoscopy.  The new tablets are also free of microcrystalline cellulose, a tablet binder used in Visicol that is sometimes visible during colonoscopy.  The Company plans to launch a Phase 3 study of the new formulation later this year.  FDA has indicated to the Company that one Phase 3 study could support approval of the new product with supportive results of the Phase 2 study.  The Company has filed a patent application that, if granted, would protect the new formulation until 2024. 

“We are very pleased with the way our new formulation study enrolled,” said Martin Rose, M.D., J.D., InKine’s Executive Vice President for Research and Development.  “It enrolled faster than our aggressive timeline, suggesting that both the investigators and their patients share our enthusiasm for INKP-102.  We look forward to analyzing the Phase 2 study results and commencing the Phase 3 study,” added Dr. Rose.        

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 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 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.