Synovics begins development of third generic controlled-release drug

By E. Janene Geiss

Philadelphia, June 9 - Synovics Pharmaceuticals, Inc. said Friday that its wholly owned subsidiary, Synovics Laboratories, Inc., has begun the process for U.S. chemical, manufacturing and control development of its third controlled-release generic drug candidate, SNG1003.

The company said it is developing three doses of SNG1003, which together address a branded drug with annualized sales in excess of $500 million, according to a company news release.

Concurrently, the company said it plans to conduct pivotal biostudies according to Food and Drug Administration guidelines to demonstrate bioequivalency that provides confirmation of the successful formulation and biostudies data achieved in India.

Following successful completion of development efforts with SNG1003, and the company's previously announced drug candidates, SNG1001 and SNG1002, Synovics said it expects to file a series of abbreviated New Drug Applications with the FDA.

There is no generic version or aNDA filed with the FDA for the brand targeted by SNG1003.

If this situation remains when Synovics files its intended aNDA, the company said it could be awarded a period of marketing exclusivity.

Synovics is a Phoenix specialty pharmaceutical company that develops controlled-release generic drugs and improved formulations of previously approved drugs.

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