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FDA Approves Nuflexxa for Osteoarthritis of the Knee

EAST BRUNSWICK, N.J., Dec 7, 2004 (BUSINESS WIRE) -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today it received approval from the U.S. Food and Drug Administration (FDA) for its premarket approval application (PMA) for Nuflexxa(TM) (1% Sodium Hyaluronate). Nuflexxa is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). The product is also approved in Europe where it will be marketed under the brand name Euflexxa(TM).

Nuflexxa is the first and only non-avian derived HA approved in the U.S. It is a product of Bio-Technology General (Israel) Ltd., Savient's wholly-owned subsidiary.

Savient is in the process of completing a supplement to the labeling to support room temperature storage versus the refrigerated expiration dating approved by the FDA. The supplement is expected to be submitted early in the first quarter of 2005.

The Company is in late-stage negotiations with a global marketing partner for both Nuflexxa in the United States and Euflexxa in Europe. These negotiations are expected to conclude early in 2005.

"We are pleased to have reached this milestone in the development of Nuflexxa. We believe its commercialization in 2005 represents additional value to our previously announced potential divestiture of our subsidiary Bio-Technology General (Israel) Ltd.," said Christopher G. Clement, President and CEO of Savient Pharmaceuticals, Inc.

The US CDC and the Arthritis Foundation report that the number of Americans with arthritis or chronic joint symptoms in 2002 was estimated at 70 million (1 in 3 adults), twice the prevalence of 1985. According to a study recently published by Millennium Research Group, in 2004 the U.S. market for hyaluronic acid (HA) treatments of osteoarthritis is approximately $350 million, an increase of 11% from 2003.

Source: Savient Pharmaceuticals

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