InKine Announces Agreement With FDA to Proceed With First Pivotal Trial of Colirest in Patients With Crohn's Disease.

Business Editors, Health/Medical Writers

BLUE BELL, Pa.--(BUSINESS WIRE)--Feb. 27, 2001

InKine Pharmaceutical Company, Inc, (NASDAQ: INKP) today announced that the U.S. Food and Drug Administration (FDA) has agreed that InKine may proceed with its planned pivotal study of Colirest(TM) in patients with active Crohn's disease (CD). FDA determined that the planned randomized, double blind, placebo-controlled dose ranging study fulfills the requirements for the design of a pivotal study and with positive results could count as one of the two pivotal studies required for the approval of Colirest. FDA reviewed the data from InKine's completed Phase II trial in patients with CD and the pivotal study protocol. FDA agreed with InKine's endpoints and statistical analysis plan for the pivotal study, including its strategy to perform an interim analysis of the study data to plan the second pivotal trial of Colirest in patients with CD. The initial pivotal trial, powered at 90%, will enroll approximately 250 patients and will evaluate Colirest at a total daily dose of 400 mg and 1000 mg vs. placebo for 8 weeks. The Company plans to launch the trial of Colirest in CD by the end of next quarter.

Colirest, formulated as tablets for oral administration, is a steroid molecule that is under development by InKine for the treatment of inflammatory bowel disease (IBD), including the closely related conditions of CD and ulcerative colitis (UC). Colirest differs structurally and pharmacologically from the glucocorticoid class of steroids that include prednisone and other agents commonly used to treat a variety of inflammatory conditions, including CD and UC. Data from several sources suggest that Colirest may provide the anti-inflammatory effects of conventional glucocorticoids with fewer and less severe glucocorticoid side effects. These sources include InKine's pilot studies in patients with CD and UC, its 3-month study of ITP, and several independent preclinical studies. Prednisone and other glucocorticoids are among the most effective and widely used drugs for the treatment of acute flares of CD and UC, but their use is frequently limited by the occurrence of significant side effects such as osteoporosis, diabetes, and psychic disturbances.

CD affects approximately 500,000 persons in the U.S. CD often produces significant morbidity, including hospitalization, surgery, and days lost from school or work. UC, the other common form of IBD, affects another 500,000 persons in the U.S. and also causes significant morbidity.

Martin Rose, M.D., J.D., InKine's Executive Vice President for Research and Development, said, "Our agreement with FDA on the details of Colirest's first pivotal study marks the attainment of a critical milestone in the Colirest development program. Since FDA has agreed that we can proceed with the study and perform an interim analysis of the study data to plan our second pivotal trial, we have the potential to significantly accelerate the development of Colirest."

Leonard S. Jacob, M.D., Ph.D., Chairman and CEO of InKine, said, "I am very pleased that we were able to reach agreement with FDA to start pivotal trials of Colirest in patients with Crohn's disease. Experts in IBD have informed us that if our clinical trials confirm the available evidence that Colirest has glucocorticoid-like efficacy with a superior side effect profile, Colirest would have great value as a treatment for Crohn's disease, ulcerative colitis, and other forms of IBD. I am excited about Colirest's potential to improve the health of patients who suffer from these debilitating conditions."

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. Support of early-stage product opportunities comes through its university-based sponsored research. The Company's lead product, Visicol(TM), was launched in January 2001 and is the first and only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. In February 2001 InKine announced a co-promotion agreement with Procter & Gamble Pharmaceuticals for Visicol. InKine's portfolio also includes three late-stage product candidates, IBStat(TM) in development for the treatment of spasm in the colon, Hematrol(TM), in Phase III trials for the treatment of idiopathic thrombocytopenic purpura and Colirest(TM), in Phase II trials for the treatment of inflammatory bowel disease. In addition, the Company is developing preclinical compounds from its two platform technologies, including Angiocidin(TM), a potent and specific angiogenesis inhibitor for potential use in cancer patients. For further information, please visit InKine on their web site http://www.inkine.com.

THIS ANNOUNCEMENT CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS THAT ARE SUBJECT TO RISKS AND UNCERTAINTIES, INCLUDING IN PARTICULAR THE STATEMENTS REGARDING COLIREST'S POTENTIAL TO IMPROVE THE HEALTH OF PATIENTS WHO SUFFER FROM THESE DEBILITATING CONDITIONS. SUCH STATEMENTS REFLECT MANAGEMENT'S CURRENT VIEWS AND ARE BASED ON CERTAIN ASSUMPTIONS. ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE CURRENTLY ANTICIPATED AS A RESULT OF A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, THE RISKS AND UNCERTAINTIES DISCUSSED UNDER "OTHER FACTORS TO BE CONSIDERED" AND "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS" IN THE COMPANY'S ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED JUNE 30, 2000, AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.