"We are excited about this collaboration with bioRASI and the strategy we set forth in this agreement," said Jeffrey Davis, Access Pharmaceuticals' President and CEO.  He continued, "Capitalizing on bioRASI's distinct expertise in developing drugs for diabetes and in obtaining necessary regulatory approvals provides Access with a solid foundation for accelerated and cost-effective development of our Cobalamin oral insulin product and future Cobalamin-based products.  We believe our Cobalamin drug delivery technology has been an undervalued part of our portfolio and we look forward to demonstrating its true value."

bioRASI is a full-service global CRO specializing in the accelerated development of novel therapeutics through its close collaboration with the Russian Academy of Sciences and extensive experience with Russian and other Eastern European regulatory systems.  In addition, through its partnership with The Diabetes Research Institute at the University of Miami Miller School of Medicine, bioRASI has considerable expertise in the areas of development of drugs for the treatment of diabetes.  bioRASI is primarily focused on the development and approval of pharmaceutical products under 505(b)(2) and 505(j) NDA regulatory pathways. The Cobalamin-based oral insulin product approval path is expected to be a 505(b)(2) process.

Boris Reznik, PhD, President and CEO of bioRASI commented, "This program is a great fit for the capabilities of both bioRASI and our established partners.  Given the well understood clinical utility of insulin, establishing the human oral bioavailability of Access' product could be a huge step forward for both the oral insulin product and the broader Cobalamin formulation technology platform.  Following initial success in the oral insulin program, we look forward to expanding this collaboration to several other promising Cobalamin-based products."

SOURCE Access Pharmaceuticals, Inc.