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Savient Shares Fall Ahead of Krystexxa Panel Review

By Pharmaceutical Processing | June 10, 2009

NEW YORK (AP) — Shares of Savient Pharmaceuticals Inc. sank Wednesday as analysts questioned whether the company’s gout drug candidate Krystexxa will receive a positive review at a regulatory panel meeting next week. An FDA panel is scheduled to review the drug on Tuesday. The drug is intended to improve the symptoms of treatment-failure gout, but two analysts said they don’t expect a positive review, and a third predicted slower sales growth for the drug. In afternoon trading, shares of the East Brunswick, N.J., company fell 44 cents, or 6.7 percent, to $6.12. Oppenheimer analyst John Newman said Wednesday he expects a negative review for Krystexxa because of evidence from clinical trails that links the drug to cardiovascular risks and increased death. He maintained an “Underperform” rating on the stock, and said he thinks the shares will fall to about $2 after the review. The FDA is not required to follow the recommendations of its advisory panels, but it often does so. Jefferies analyst Eun Yang wrote last week the panel ruling may not be favorable, and she said she does not think the FDA will approve the drug this summer. Wedbush Morgan analyst Kimberly Lee believes the drug will be approved, but she said in a note Wednesday sales may take longer to pick up than she initially thought. Lee thinks revenue from Krystexxa will peak at $400 million, but based on the slower growth, she slashed her price target on Savient stock to $15 per share from $31. Lee thinks Krystexxa, or pegloticase, will be approved because there is a significant need for the drug and it appears to be effective. She thinks the FDA will impose labeling restrictions and post-approval requirements.

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