CPEX Pharmaceuticals, and privately held Serenity Pharmaceuticals has formed collaboration on an intranasal drug candidate for a urology indication. New York-based Serenity's drug candidate will be delivered using CPEX's patented drug delivery technology. Serenity believes the drug targets a potential worldwide market of $2 - $3 billion.

The collaboration between Serenity and CPEX began in September 2007 as a feasibility study and advanced to the signing of a development and license agreement in February 2008. Serenity has filed an Investigational New Drug (IND) application with the FDA to initiate phase-I clinical testing. "We are delighted to be working with Serenity in a truly collaborative manner," said John Sedor, CPEX Pharmaceuticals' president and chief executive officer. "CPEX provided access to its intellectual property, developed the formulations, produced a pilot scale manufacturing process and prepared clinical and stability supplies. Our expertise in product and process development and Serenity's clinical expertise in specialty areas have quickly proven to be a complementary fit."

Dr Samuel Herschkowitz, Serenity Pharmaceuticals' CEO, said, "We have been consistently impressed with CPEX's platform technology, its expertise and its infrastructure. From the beginning, we found CPEX to be an excellent partner, and we have made progress in advancing our drug from concept into phase-I development with their assistance. Based on the profile of their delivery platform and our current R&D pipeline, we are hopeful that we can collaborate with CPEX on additional drug candidates in the future."

Sedor said, "Including the launch of Serenity's phase-I trial, our CPE-215 drug delivery platform has formed the basis for the filing of three separate INDs, all of which represent diverse therapeutic areas: testosterone replacement, diabetes and urology. This diversity speaks to the broad applicability of our technology and its potential to effectively deliver pharmaceutically active peptides, peptidomimetics and proteins across a variety of membranes."

"Today's announcement also demonstrates how we can capitalize on the value of our technology in ways that can increase our shareholder value," Sedor continued. "We received a patent in late July 2007 that extended the coverage for our intranasal drug delivery technology utilizing CPE-215 beyond insulin. We signed an agreement to begin working with Serenity less than three months later we believe this partnership is indicative of how platform can generate opportunities for future potential revenue streams."

Serenity Pharmaceuticals is a privately held, New-York based start-up urology company.

CPEX Pharmaceuticals is a specialty pharmaceutical company focused on the development, licensing and commercialization of pharmaceutical products utilizing CPEX's validated drug delivery technology.