svnt info...
Some in the room bought this one Monday, seems to be a conflict between what the analyst downgraded and the PR sent out by the company. Watch for a correction pr in the morning, I have emailed IR and will post when I get a response.
Savient Shares Tumble on Safety Data from Extension
By Anette Breindl
Science Editor
Shares of Savient Pharmaceuticals Inc. tumbled 73.5 percent Monday after the company presented data on its pegloticase (Puricase) for treatment-resistant gout. Even though the drug has met its endpoint in two Phase III studies, analysts were skeptical about a key safety issue, its prospects for approval, and the size of its market if it is approved.
Gout is a form of arthritis caused by an accumulation of uric acid in the joints that can result from making too much urea, or not metabolizing it properly. More than 1 million Americans have a gout attack each year, most of them males older than 40.
In data unveiled at the American College of Rheumatology, researchers presented data on two Phase III studies, GOUT1 and GOUT2. Topline results of both studies were first presented late last year. In both studies, the drug hit its endpoint, normalizing plasma uric acid levels during month 3 and month 6 of the trials. (See BioWorld Today, Dec. 14, 2007.)
New data presented at ACR showed that gout flares - acute gout attacks - decreased by about 40 percent in patients receiving pegloticase every two weeks compared to those receiving placebo. Gout tophi - deposits of crystallized uric acid in soft tissue - showed a complete response in patients receiving pegloticase every two weeks, as well as in the pooled response from patients receiving the drug every two weeks and every four weeks. But the third time was the charm for Puricase. The data included an uncontrolled open-label extension study known as GOUT 3 that failed to convince analysts of the drug's prospects.
The company's take on the data was positive: In a press release, Savient described the results as showing that "a substantial subset of patients who completed the Phase III clinical trials and enrolled in the [open-label extension] continued to show improvements in the resolution of their signs and symptoms of treatment-failure gout with continuing pegloticase treatment, extending the positive clinical results seen in Phase III. The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an increasing proportion of patients with favorable response over time."
The East Brunswick, N.J.-based company said that the drug has "an acceptable safety and tolerability profile" when administered every two or every four weeks, and that "the emerging safety profile of long-term pegloticase therapy is consistent with that observed in the six double-blind studies, with no apparent new safety concerns related to long-term exposure."
On this point, however, some analysts disagreed.
Rachel McMinn of Cowen & Co. wrote in a note that "The surprising new information for investors is that Puricase in Phase III was associated with cardiovascular adverse events in 5 percent of patients vs. 0 percent for placebo patients."
Savient itself reported one cardiovascular death in the placebo group, but that patient died before receiving any placebo. Both Cowen, which downgraded Savient on Monday, and Jeffries & Co., which lowered its price target on the company, cited the higher rate of cardiac adverse events in the treatment group as cause for concern.
Analysts also said it is unlikely that pegloticase will win FDA approval on its first attempt, given that the company said it plans to file a biologics licensing application by the end of this month and expects approval in the first half of 2009. But Cowen's report cited a "lack of conviction" that pegloticase will receive first-pass FDA approval as one reason for the downgrade. Cowen noted that cardiovascular events as well as adverse infusion reactions, including anaphylactic shock-like reactions, "complicate the risk-reward profile of the drug."
And Jefferies and Co. noted that trouble could await from "an overly cautious FDA," particularly its division of anesthesia, analgesia and rheumatology, which was burned by the Vioxx episode.
Credit Suisse analysts, however, were more positive, saying that because of the small size of the study, 4:1 randomization, and patient comorbidities, it is impossible to ascertain any statistically significant imbalance.
One dual-edged sword for the company is that its drug is aimed at treatment-refractory patients who have exhausted other treatment options and are, on the average, very ill. While that makes side effects more acceptable than with a milder disease, it also means that the potential market is fairly small - another reason cited by analysts for their skepticism. Savient will present further data on the immune response of patients receiving long-term treatment with pegloticase at the conference tomorrow, and will conduct a conference call on Wednesday.
Shares of Savient (NASDAQ:SVNT) dropped $8.51, to close at $3.07.
Savient wasn't the only company presenting gout data at the ACR. San Diego-based Ardea Biosciences presented Phase I data at the meeting showing that its RDEA594, for hyperuricemia and gout, showed what the company termed "a favorable pharmacokinetic profile with low systemic clearance, favorable absorption and a half-life supporting once-daily dosing." 100 mg daily of the drug also significantly increased the excretion of uric acid.
And Xoma, Inc., of Berkeley, Calif., presented data showing that its XOMA052 blocks inflammation in a mouse model of gout.
The following data were presented at the American College of Rheumatology Annual Scientific Meeting in San Francisco.
• Amgen Inc.,
