|Savient Up As Investors More Confident In Drug Approval|
Last update: 5/29/2009 2:53:16 PM
By Shara Tibken
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Shares of Savient Pharmaceuticals Inc. (SVNT) climbed as much as 14% Friday as analysts said investors were more confident the company's drug to treat gout would receive approval from a U.S. Food and Drug Administration panel on June 16.
Collins Stewart analyst Salveen J. Kochnover said in a note Friday that her firm recently hosted a dinner with a former FDA Arthritis Advisory Committee member and current Savient consultant, Dr. Lee Simon. She said he suggested Krystexxa, the company's drug to be used in treatment-failure gout patients, is approvable.
"In addition, SVNT has lined up a group of external, top-tier rheumatologists, immunologists and cardiologists with FDA experience to present on Krystexxa to the panel ..., which he believes should lend credibility to the data," Kochnover wrote.
A representative from Savient wasn't immediately available to comment Friday.
In recent trading, shares were up 9.2% to $6.28. Shares rose as high as $6.56 earlier Friday, up about 50% over the past three months. Shares have been hammered over the past 12 months as investors were concerned about the safety of Krystexxa.
The company said in October that seven people in the study died after taking the drug, raising concerns about cardiovascular side effects.
Several analysts said they believe the drug could receive a favorable FDA panel review, as the company has spent a significant amount of time preparing for the panel and as the FDA could determine the rewards of the drug outweigh the risks.
"We expect the FDA to determine the drug has a good risk benefit in a defined patient population of treatment failure gout patients," Leerink Swann analyst Joseph P. Schwartz told Dow Jones Newswires, adding investors are looking for Savient to deliver a "sound" REMS, or risk evaluation and mitigation strategy.
Schwartz said the REMS program is the FDA's new initiative to ensure safety of drugs with known risks. He said that by limiting what patients take the drug, the risk is minimized.
"They could prevent people with multiple cardiovascular risk factors from getting it, as well as people who don't respond to it any longer," Schwartz said, adding a similar gout drug developed by Takeda Pharmaceutical Co. (4502.TO) was approved earlier this year, though it has a less well-defined population and didn't clarify the cardiovascular risk profile.
"There is a limited number of people with a medical need for Krystexxa - about 15,000 in the U.S. - so the company should have a good chance of convincing the FDA there's a favorable risk benefit," Schwartz said.
Oppenheimer & Co. analyst John Newman, meanwhile, said he doesn't believe the drug will be approved by the FDA as the safety concerns are too high.
"The efficacy is good," Newman told Dow Jones Newswires. "But it could be killing patients."
-By Shara Tibken, Dow Jones Newswires; 201-938-2168; firstname.lastname@example.org;
(END) Dow Jones Newswires
May 29, 2009 14:53 ET (18:53 GMT)