PHOENIX--(BUSINESS WIRE)--June 9, 2006--Synovics Pharmaceuticals, Inc. (OTCBB:SYVC - News), a specialty pharmaceutical company with proprietary technologies for the development of controlled-release generic and branded oral drugs, today announced that its wholly owned subsidiary, Synovics Laboratories, Inc., has initiated the process for U.S. chemical, manufacturing and control (CMC) development of its third controlled-release generic drug candidate, SNG1003. The Company is developing three doses of SNG1003 (a, b and c), which together address a branded drug with annualized sales in excess of $500 million. Concurrently, the Company plans to conduct pivotal biostudies according to U.S. Food and Drug Administration (FDA) guidelines to demonstrate bioequivalency that provides confirmation of the successful formulation and biostudies data achieved in India. Following the successful completion of development efforts with SNG1003a, b and c, and the Company's previously announced drug candidates, SNG1001a and SNG1002a, Synovics Pharmaceuticals expects to file a series of Abbreviated New Drug Applications (ANDAs) with the FDA. There is currently no generic version nor ANDA filed with the FDA for the brand targeted by SNG1003. If this situation remains when Synovics files its intended ANDA, the Company could be awarded a period of marketing exclusivity.
