OsmoPrepTreatment for Bowel Preparation
InKine Announces the Acceptance for Filing of Its New Drug Application (NDA) for Its Next Generation Purgative Product -- INKP-102
BLUE BELL, Pa., July 26, 2005 - InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced that the United States Food and Drug Administration (FDA) has accepted for filing InKine's New Drug Application (NDA) for INKP-102, the Company's next-generation purgative product. The successful filing of the NDA denotes that the FDA has determined that the application is sufficiently complete to permit a substantive review. FDA also notified InKine that clinical audits of its Phase III trial sites will commence shortly.
"This filing by the FDA is an important milestone in commercialization of INKP-102," stated Chairman and CEO Leonard S. Jacob, M.D., Ph.D. "We believe that, if approved, INKP-102 will represent a substantial improvement for adult patients undergoing colonic cleansing for diagnostic procedures such as colonoscopy."
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 provide protection for INKP-102 until 2024.
InKine submitted the NDA for INKP-102 during the second quarter of 2005. 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. These trials indicate that INKP-102 may have important advantages over Visicol tablets in efficacy, safety and acceptance by patients.
The Company anticipates that, if approved, the commercial launch of INKP-102 will occur in the first half of 2006. However, there can be no assurance INKP-102 will receive FDA approval. Without FDA approval, the Company cannot market or sell INKP-102.
Posted: July 2005
- InKine Announces Submission of a New Drug Application -NDA- for Its Next Generation Purgative Product - INKP-102 - May 3, 2005