InKine Announces Positive Phase 3 Study Results of Next Generation Purgative Product - INKP-102.

BLUE BELL, Pa. -- InKine Pharmaceutical Company, Inc. (Nasdaq:INKP) today announced positive results of the Company's multicenter, Phase 3 study of its next generation sodium phosphate tablet, INKP-102. The recently completed, randomized, investigator blinded non-inferiority Phase 3 study included 706 adults who underwent colonoscopy. Patients received either 32 tablets ("reduced-dose") or 40 tablets ("comparator dose") of INKP-102 or the FDA-approved dose of 40 Visicol(R) tablets. Both of the INKP-102 arms utilized a dosing schedule that was of shorter duration, more convenient, and less complicated than the Visicol(R) dosing regimen. Approximately 25% of patients in the study were at least 65 years old and the study population included slightly more women than men and included all major U.S. ethnic groups.

Over 94% of patients in each study arm were responders. A responder was a patient who received an overall colon cleansing rating (the study protocol's specified primary endpoint) of "excellent" or "good" on a 4-point scale. The primary efficacy analysis convincingly demonstrated non-inferiority of both INKP-102 dose regimens to Visicol(R). For the comparison of each INKP-102 regimen to Visicol(R), the p value for the non-inferiority test was less than 0.0001, a highly significant result.

For all of the protocol-specified secondary efficacy endpoints, INKP-102 was significantly superior or comparable to Visicol(R). In the ascending colon (the right side of this organ), where retained material, such as stool and MCC, is most often seen, each INKP-102 arm was statistically superior to Visicol(R) for all tested endpoints. During a colonoscopy, physicians use water to irrigate (wash away) retained material in the colon, including stool and MCC. Both of the INKP-102 doses were statistically superior to Visicol(R) in terms of the amount of irrigation fluid used during the colonoscopy procedure, another indication of the cleansing superiority of INKP-102. There were no statistically significant differences in any of the efficacy-associated endpoints between the two INKP-102 arms.

"In this study, the reduced-dose of INKP-102 was significantly superior or comparable to Visicol(R) in all of the efficacy analysis performed," said Robyn G. Karlstadt, M.D., FACG, Vice President for Clinical Operations at InKine. "There were no significant differences in efficacy between the two INKP-102 dose regimens. However, the lower dose of INKP-102 showed some important safety advantages over both the labeled dose for Visicol(R) and the comparator dose of INKP-102. Patient acceptance of the reduced-dose was better than or comparable to acceptance of Visicol(R) for all the items in the patient questionnaire. We believe that the physicians who perform colonoscopy will recognize that reduced-dose INKP-102 therapy represents a substantial improvement over Visicol(R) in terms of efficacy, safety, and patient acceptance," added Dr. Karlstadt.

Patient acceptance and preferences were assessed using a questionnaire that was completed by the patient just before their colonoscopy procedure. For all questions, responses for the patients who received the reduced-dose of INKP-102 were statistically significantly more favorable than or comparable to responses for those who received Visicol(R). Notably, patients who took the reduced-dose INKP-102 regimen found the preparation easier to take than Visicol(R) and were more likely to take the preparation they just received for a future colonoscopy. For these parameters, the differences in favor of the reduced-dose of INKP-102 were highly statistically significant.

"This study confirms InKine's belief that delivery of a MCC-free sodium phosphate tablet regimen administered at a lower dose with less liquid volume, would result in improved efficacy and safety compared to currently marketed Visicol(R) tablets," said Leonard S. Jacob, M.D., Ph.D., Chairman and CEO of InKine. "We have conducted several studies to date which have demonstrated that Visicol(R) is the patient preferred purgative. The data from this study indicates that INKP-102 represents an improvement over Visicol(R) in key aspects of efficacy, safety, and patient preference. We believe that if approved by FDA, INKP-102 could significantly expand InKine's share of the market for colon cleansing products and could emerge as the physician preferred purgative," added Dr. Jacob.

Safety endpoints included assessment of adverse event rates and blood chemistry changes from the screening visit to the time of colonoscopy. Generally, adverse event rates were lower in the reduced-dose of INKP-102 arm than in the Visicol(R) arm. Statistical comparisons were performed for gastrointestinal adverse events in the Integrated Summary of Safety (ISS) database, which combines the safety data from the Phase 2 and Phase 3 studies. The four most common adverse events typically experienced in studies of purgatives are gastrointestinal complaints of abdominal distension, nausea, abdominal pain, and vomiting. Compared to Visicol(R), the reduced-dose of INKP-102 had a statistically significantly lower rate of all gastrointestinal adverse events combined, abdominal distension (the most common adverse event in all three Phase 3 study groups), and vomiting (generally considered the most medically important of the common gastrointestinal adverse events). In the Phase 3 study, and in the combined ISS database, the reduced-dose of INKP-102 was significantly superior or comparable to Visicol(R) (and in some cases, superior to the comparator dose of INKP-102) in terms of the transient changes in blood chemistry parameters that are known to occur with sodium phosphate colon cleansing products.

INKP-102 tablets are smaller in size and easier to swallow than the Company's currently marketed Visicol(R) tablets. The new INKP-102 tablets contain no microcrystalline cellulose (MCC), an inert, but highly insoluble, tablet binder. The Company has filed a patent application that, if granted, would protect INKP-102 until 2024.

FDA had previously reviewed the study protocol under its "Special Protocol Assessment" procedure, and had approved every major design feature of this study. FDA has indicated to the Company that a New Drug Application (NDA) for INKP-102 could be submitted with data from a Phase I, a single Phase 2 and a single Phase 3 study, if the Phase 2 study were supportive and the Phase 3 study convincing. The Company believes these criteria have been met, and plans to submit the NDA for INKP-102 in the second quarter of 2005. There can be no assurance the FDA will accept the NDA for filing or that INKP-102 will receive FDA approval. Without FDA approval, the Company cannot market or sell INKP-102.

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(R) is the only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat(R), is an oral hyoscyamine spray for the treatment of a variety of indications. Additionally, the Company is developing INKP-102, an advanced generation purgative, which recently completed Phase III clinical trials for bowel cleansing prior to colonoscopy and studying Visicol(R) for use as a laxative in treating patients with chronic 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 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.