Shares of Savient Pharmaceuticals Inc. Soar Despite FDA Concern Over Drug Safety (SVNT)

By Douglas A. McIntyre Updated Apr 28, 4:41AM EDT · Published Jun 13, 6:22AM EDT

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under Shares of Savient Pharmaceuticals Inc. (Nasdaq: SVNT) climbed on Friday after an announcement by the FDA that the company’s drug Krystexxa appears to successfully treat gout, despite evidence of potentially deadly side effects.

Savient ended the day on Friday up 3.33 (56.16%) with a closing price of 9.26.

The FDA said that the drug appears to relieve swollen joints and pain flare- ups associated with gout, a condition caused by the buildup of uric acid in the body.

Krystexxa is an injectable enzyme designed to lower the body’s uric acid levels when administered either once or twice a month. Gout affects about 8 million Americans and is most commen in men over 40, according to the FDA.

Safety concerns were raised as side effects such as heart problems and allergic reactions were witnessed during clinical trials.

Dr. Bob Rappaport, head of the FDA division that handles rheumatology drugs, is quoted as saying, “The Food and Drug Administration’s review of two company studies raised several concerns, including a greater number of patients taking Krystexxa who suddenly died or had heart failure as well as allergic reactions.”

About 24 percent of patients taking Krystexxa suffered a serious side effect, compared with 12 percent of patients taking a placebo pill. There were six deaths among patients taking the drug compared with three among patients taking the placebo, though the FDA noted many of them had pre-existing heart conditions.

The FDA is scheduled to ask a panel of outside arthritis experts next Tuesday to weigh- in on the drug’s risks and benefits. The panel would determine whether additional studies would be needed to evaluate Krystexxa’s impact on the heart. A final decision on Savient’s drug is expected by the end of July.

Collins Stewart analyst Salveen Kochnover said that Savient’s drug can likely win approval so long as the company agrees to limit its use to the target patient population and closely monitors any negative side effects. Savient is specifically seeking an alternative for gout patients who are not receiving relief from other treatments.

Kochnover also noted that seven of the 16 panelists slated to vote on the drug are rheumatologists who are likely in favor of the new treatment.

Joshua Sherman

About the Author Douglas A. McIntyre →

Douglas A. McIntyre is the co-founder, chief executive officer and editor in chief of 24/7 Wall St. and 24/7 Tempo. He has held these jobs since 2006.

McIntyre has written thousands of articles for 24/7 Wall St. He is an expert on corporate finance, the automotive industry, media companies and international finance. He has edited articles on national demographics, sports, personal income and travel.

His work has been quoted or mentioned in The New York Times, The Wall Street Journal, Los Angeles Times, The Washington Post, NBC News, Time, The New Yorker, HuffPost USA Today, Business Insider, Yahoo, AOL, MarketWatch, The Atlantic, Bloomberg, New York Post, Chicago Tribune, Forbes, The Guardian and many other major publications. McIntyre has been a guest on CNBC, the BBC and television and radio stations across the country.

A magna cum laude graduate of Harvard College, McIntyre also was president of The Harvard Advocate. Founded in 1866, the Advocate is the oldest college publication in the United States.

TheStreet.com, Comps.com and Edgar Online are some of the public companies for which McIntyre served on the board of directors. He was a Vicinity Corporation board member when the company was sold to Microsoft in 2002. He served on the audit committees of some of these companies.

McIntyre has been the CEO of FutureSource, a provider of trading terminals and news to commodities and futures traders. He was president of Switchboard, the online phone directory company. He served as chairman and CEO of On2 Technologies, the video compression company that provided video compression software for Adobe’s Flash. Google bought On2 in 2009.