Synovics Pharmaceuticals intends to acquire exclusive, worldwide rights to the development and commercialization of PharmPro's OTC version of omeprazole, proton pump inhibitors (PPI) that block the production of acid by the stomach.
PPIs are used to treat ulcers, gastroesophagel reflux disease, and Zollinger-Ellison Syndrome. The U.S. market for the branded omeprazole OTC is greater than $600 million, according to Synovics.
Fluid Air, PharmPro’s parent company, will receive certain milestone payments together with a royalty on gross revenue upon approval and product launch.
Initial development work for the omeprazole OTC drug product is complete and utilizes Fluid Air's DuraGran process as an integral element of the manufacturing procedure for the product. Following finalization of due diligence, Synovics expects to move into production of the required registration batches and pivotal bioequivalence clinical trials followed by submission of an ANDA in the second half of 2007.
"Following the completion of our clinical trials,” says Ronald H. Lane, Ph.D., Synovics chairman and CEO, “Fluid Air will manufacture and deliver the product in bulk to our subsidiary, Kirk Pharmaceuticals, to facilitate cost-effective packaging, shipping, and distribution."