Savient Pharmaceuticals Said It May Not Need New Trials Of Gout Drug Candidate (SVNT)

Wed. September 16, 2009; Posted: 09:30 AM

Sep 16, 2009 (SmarTrend(R) News Watch via COMTEX) -- SVNT | Quote | Chart | News | PowerRating -- 9/16/2009 - Savient Pharmaceuticals Inc. (NASDAQ:SVNT) said Wednesday that it does not think it will have to run new trials of Krystexxa, a chronic gout drug candidate, and believes that it will complete a new regulatory submission for the drug candidate in early 2010. The FDA declined to approve Krystexxa in August due to Savient changing the way the drug was manufactured, among other issues. After a meeting with the FDA on Monday, the company said the FDA does not expect to require another late stage test because the drug is essentially the same regardless of the manufacturing process. The FDA also told the company that it will need to correct problems at a manufacturing facility in Israel and will accept a safety update on Krystexxa.

Write to Chip Brian at cbrian@tradethetrend.com

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For full details on Savient Pharmaceuticals Inc (SVNT) click here. Savient Pharmaceuticals Inc (SVNT) has Short Term PowerRatings of 4. Details on Savient Pharmaceuticals Inc (SVNT) Short Term PowerRatings is available at This Link.

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