Savient Pharmaceuticals Inc (fka SVNTQ)

[surf1944]

PREVIEW-Marketing, not approval, a worry for Savient gout drug
Thu Jul 30, 2009 1:05pm EDT

* What: FDA verdict due on gout drug Krystexxa by Aug 1

* Approval expected, but post-marketing trials likely

* Analysts concerned about co's ability to market drug

By Esha Dey

BANGALORE, July 30 (Reuters) - Savient Pharmaceuticals Inc's (SVNT.O) potential gout drug, Krystexxa, is expected to have a smooth path to U.S. regulatory approval, even though adverse events reported during trials may result in the company being required to conduct post-approval studies.

But analysts are more concerned about the company's ability to take the drug to market and see a strong likelihood of the company being bought out. The drug, known generically as pegloticase, has been under close scrutiny after the company reported several serious adverse cardiovascular events from trials that led to the U.S. Food and Drug Administration extending the drug's review by three months.

However, analysts say that this time around the company has made a good case for the drug, which they estimate has about a 70 percent to 80 percent chance of getting approved by the FDA action date of Aug. 1.

"The remaining 20 percent to 30 percent chance is that they could get a complete response letter, needing maybe a couple of months to finish their risk management program (REMS)," Cowen and Co analyst Craig Gordon said.

The cardiology events seen during the study are not being considered a serious threat to approval as they are not completely unusual and occurred in patients with existing heart-related problems.

"At most, Savient will have to do post-approval trials to follow up (the cardiovascular) concern," Cowen's Gordon said.

On June 16, an FDA advisory panel had voted 14-1 in favor of the drug's approval, saying that the dramatic results seen in nearly half the patients studied in the trial were encouraging despite risks of heart problems and allergic reactions.

"From the comments of the panel members it sounds like there is probably no possibility of requesting (an additional) trial as this is an orphan population," Wedbush PacGrow analyst Kimberly Lee said.

"Even if they run a new trial, there aren't enough patients to make the data statistically significant."

An orphan designation is given to a treatment that will benefit fewer than 100,000 people in the United States.

About 5 million Americans have gout, in which a build up of uric acid causes swollen joints.

Of those, about 40,000 to 60,000 see no improvement with other therapies, according to the company, which is trying to get the infused drug approved for patients who do not respond to, or cannot take, alternative treatments. Continued...


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