OsmoPrep

Treatment for Bowel Preparation

InKine Announces Submission of a New Drug Application -NDA- for Its Next Generation Purgative Product - INKP-102

BLUE BELL, Pa., May 3, 2005 - InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced that on April 29, 2005 the Company submitted an electronic New Drug Application (NDA) for the United States marketing approval of its next generation sodium phosphate tablet, INKP-102.

The NDA is based on data from two randomized, multicenter, investigator-blinded clinical trials comparing INKP-102 to 40 Visicol tablets, including a Phase 2 dose-ranging trial and a Phase 3 pivotal trial. Based on the results of these trials, the dose of INKP-102 proposed for marketing is 32 tablets (48 g), compared to the approved dose of 40 tablets (60 g) for Visicol tablets. The clinical trials indicated that the 32 tablet INKP-102 dose was comparable or significantly superior to 40 Visicol tablets in all tested efficacy parameters, and met the primary efficacy endpoint of non-inferiority for the overall colon cleansing response rate in the Phase 3 trial. In the combined safety database, the 32 tablet INKP-102 dose was significantly superior to Visicol tablets in several key safety parameters. In the Phase 3 trial, patient acceptance was significantly greater with INKP-102 compared to patients who took Visicol tablets. Significantly more patients who took 32 INKP-102 tablets indicated that they would be willing to take the same preparation again for a future colonoscopy compared to those who took Visicol tablets. Results in the Phase 2 trial were supportive.

"The data in this NDA support our original belief that our new MCC-free sodium phosphate tablet would result in improved colon cleansing compared to currently marketed Visicol tablets," said Martin Rose, M.D., J.D., Executive Vice President for Research and Development at InKine. "In our studies, INKP-102 was given at a lower dose with fewer tablets than Visicol. It has a better safety profile and is better accepted by patients," added Dr. Rose.

"We are pleased to report that we have submitted our NDA for review by FDA two months ahead of our internal forecasted timeline'" said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executive Officer of InKine. "Based on the improved efficacy, safety and patient acceptance attributes, we believe that INKP-102, if approved by FDA, will be the best purgative on the market and should significantly expand InKine's share of the market for colon cleansing products," added Dr. Jacob.

INKP-102 tablets are smaller in size and easier to swallow than the Company's currently marketed sodium phosphate tablet product, Visicol. 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.

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 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 is developing INKP-102, an advanced generation purgative, which we recently submitted a new drug application to FDA for bowel cleansing prior to colonoscopy and studying Visicol for use as a laxative in treating patients with chronic constipation.
For further information, please visit www.inkine.com.

Posted: May 2005

Related Articles

OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) FDA Approval History

View comments

Hide
(web5)