.

  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 BEGINS PHASE II STUDY OF
ADVANCED GENERATION PURGATIVE PRODUCT

 

BLUE BELL, PA March 22, 2004 -- InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced the dosing of the first seven patients in a Phase II dose-ranging study using the Company’s advanced generation sodium phosphate purgative tablet, code named INKP-102.  This study, the first using INKP-102, is a multicenter, investigator-blinded trial comparing several dosing regimens of the new tablets against the Company’s currently marketed VisicolÒ tablets in adults scheduled for colonoscopy.  The study includes regimens of INKP-102 involving a reduced number of tablets and dosing that is completed the evening before the colonoscopy procedure, and will examine the safety, efficacy and patient acceptance of the new product.  FDA has indicated to InKine that this study could be supportive of a single pivotal trial in a marketing application for INKP-102.  Data from the Phase II dose-ranging study are expected to be available in the third quarter of this year.  INKP-102 tablets are smaller than VisicolÒ tablets, should be easier to swallow, and contain no microcrystalline cellulose, an inert but highly insoluble substance in VisicolÒ tablets.  InKine recently filed a provisional patent application with the U.S. Patent and Trademark Office, which, if granted, would protect INKP-102 until 2024.

 “We expect that our new generation purgative being evaluated in this study will be even better accepted by patients and their gastroenterologists, and will provide colon cleansing that is superior to VisicolÒ tablets,” said Martin Rose, M.D., J.D., InKine’s Executive Vice President for Research and Development.  “The results of this study will guide the selection of doses for our Phase III study that we will begin later this year,” 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.  Additionally, the Company has filed a provisional patent application for the development of a new generation purgative, for which clinical trials are expected to initiate during 2004, and is developing 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.