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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 ANNOUNCES PLANS TO BEGIN PHASE 2 STUDY OF ITS NEW GENERATION PURGATIVE PRODUCT

 

BLUE BELL, PA January 14, 2004 - InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) ) today announced that the Company had a meeting with the United States Food and Drug Administration (FDA) and reached agreement on the design of a Phase 2 study for a new generation of colon cleansing tablets. The new tablets are smaller and contain no microcrystalline cellulose (MCC). InKine’s new generation purgative tablet is covered by the Company’s provisional United States patent application filed late last year. If issued, products under the patent will receive protection through 2024. The Company plans to file patent applications worldwide during 2004.

"We are pleased with the results of our meeting with FDA regarding the design of a Phase 2 study and the outline of a highly efficient development program for the regulatory approval of our new highly soluble colon cleansing tablets,” said Martin Rose, M.D., J.D., Executive Vice President of Research and Development of InKine. “We will be working with a very experienced group of investigators to perform the study and are anxious to begin testing our new potential product at numerous dosing regimens, which should enhance acceptance by patients and physicians,” added Dr. Rose.

The Phase 2 study is expected to begin in the first half of 2004 and will compare InKine’s marketed purgative, Visicol? tablets, against several dosing regimens of the new product in patients undergoing colonoscopy. These regimens will include one similar to the approved regimen for Visicol as well as several lower dose regimens, including dosing regimens completed by patients entirely the evening before the colonoscopy procedure. The FDA has indicated that if results of the Phase 2 study are supportive, than only one pivotal study would be required for approval of the new tablets.

“We continue to look to expand our commercial operations through the development of our existing products and potential acquisitions. While our franchise product, Visicol, continues to gain market share, we look forward to advancing our new generation purgative through clinical development,” said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executive Officer of InKine. “With the completion of a co-promotion deal in late 2003 and our development path in place for 2004, we expect to provide 2004 income statement guidance during our fourth quarter earnings call,” added Dr. Jacob.

About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded biopharmaceutical company focused on the diagnosis and treatment of cancer and autoimmune diseases. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's first product, Visicol™ is the first and only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IBStat™, is a novel oral hysocyamine spray for the treatment of Irritable Bowel Syndrome (IBS) and spasm of the colon. Additionally, the Company is developing other clinical compounds such as Colirest™, which is in clinical trials for the treatment of Crohn's disease and completed Phase II trials for the treatment of ulcerative colitis. For further information, please visit InKine on their 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.