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Synovics Pharmaceuticals Finalizes Agreement to In-License OTC Generic Version of Omeprazole New Drug Application Targeted for Second Half of 2007 PHOENIX -- Synovics Pharmaceuticals, Inc. (OTCBB:SYVC), a specialty pharmaceutical company, today announced it has finalized a definitive agreement for a previously announced binding letter of intent for exclusive, world-wide rights to develop and commercialize the PharmPro Division of Fluid Air Inc.'s proprietary over-the-counter (OTC) version of omeprazole. The U.S. market for the branded omeprazole OTC is greater than $600 million. There is presently no approved omeprazole OTC product competitive to the brand for the U.S. market. Synovics plans to submit an application to the U.S. Food and Drug Administration (FDA) for approval to manufacture and sell omeprazole OTC in the second half of 2007. In conjunction with the in-license agreement, Synovics made front-end payments totaling $500,000 to Fluid Air. The Company has milestone payment obligations to Fluid Air during the development and launch of the drug. Upon approval by the FDA for product manufacture and launch, Synovics will have an ongoing obligation to make payments of royalties based on gross revenue. "Having a drug with the market potential of omeprazole OTC is a very significant event for the Company and we are pleased to partner with Fluid Air," said Synovics President and COO, David Coffin-Beach. "Fluid Air will undertake the chemical, manufacturing and control (CMC) development work for the product using its state-of-the-art manufacturing facilities and patented DuraGran process as an integral element of the manufacturing procedure. Following successful manufacture of the requisite drug registration batches, Synovics will move into pivotal bioequivalence clinical trials. We are currently targeting the second half of 2007 to file a product registration dossier with the FDA. Omeprazole OTC is the first in a series of potential drug candidates to be introduced to Synovics through our marketing and consulting partnership with VCG & A, Inc. (VCG)." Mike Schultz, Managing Partner of VCG, stated, "Obtaining rights to omeprazole OTC represents the first milestone in our relationship with Synovics. Our projections indicate that if trends continue through the rest of the year, the branded omeprazole OTC could have a continuing growth of sales in 2007. The timely filing and approval of this drug by the FDA could be defining events for Synovics as this drug candidate has substantial upside potential revenue generation, as well as its strategic effect on Synovics' position in the generic market. Omeprazole OTC also fits well with Synovics' new strategic direction and planned drug development program. VCG is assisting Synovics in creating and implementing a sales and marketing plan as part of their overall product development program for omeprazole OTC." About Omeprazole Omeprazole is in a class of drugs called proton pump inhibitors (PPI), which block the production of acid by the stomach. Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophagel reflux disease (GERD), and the Zollinger-Ellison Syndrome, which are all caused by stomach acid. As a PPI, omeprazole blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, which allows the stomach and esophagus to heal. About Synovics Synovics is a specialty pharmaceutical company engaged in the development, manufacturing and commercialization of prescription Oral Control Release (ORC) generic and Immediate Release (IR) drugs, improved formulations of previously approved drugs and OTC drugs. The Company has two operating subsidiaries, Kirk Pharmaceuticals, Inc. and ANDAPharm, Inc., which manufacture and sell OTC and prescriptions private label drugs respectively. In July 2006 Synovics announced the approval of its first ANDA by the FDA, 500 mg metformin XR. In March 2007, the Company announced that it had entered into a binding letter of intent for exclusive, world-wide rights to the development and commercialization of the PharmPro Division of Fluid Air Inc.'s proprietary OTC version of omeprazole. |
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For further information, please contact: Betty B. Bender |
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