FDA slams Bayer's anti-clotting drug; Pharmasset sees home run results Print E-mail
By Staff and Wire Reports   
Tuesday, 06 September 2011 10:21
fda calendarShares of drug developer Pharmasset (NASDAQ: VRUS) climbed early on Tuesday after the company hit a "home run" with results from a mid-stage study of a potential hepatitis C virus treatment.

The Princeton, N.J., based company said results from a study of the drug candidate labeled PSI-7977 showed that 91 percent of the subjects enrolled, or 43 out of 47 patients, had undetectable levels of the virus 12 weeks after their treatment stopped. The company is studying a 400-milligram dose of PSI-7977 used in combination with two other treatments in patients with a form of the hepatitis C virus who had not been treated previously.

In other news, officials at the FDA dropped a bombshell on the anti-clotting drug Xarelto this morning, noting in an agency review that Bayer (OTCBB: BAYZF.PK) and Johnson & Johnson (NYSE:JNJ) had offered insufficient data on safety as well as efficacy for preventing strokes among atrial fibrillation patients, urging an advisory committee to send researchers back to the clinic for another study. In a matter of minutes shares of Bayer dropped 12%, a substantial drop for a big pharmacutical company stock.

“There is a lack of substantial evidence that rivaroxaban will have its desired effect when used as recommended in labeling,” the FDA reviewers wrote. Also, “there is insufficient information about the drug to determine whether it is safe for use with its proposed labeling.”The staff reviewers are worried about Xarelto actually leading to future strokes or other risks.

On Thursday, the company faces a panel of medical experts advising the Food and Drug Administration on whether the blood thinner Xarelto should be marketed to ward off strokes in people with an abnormally fast heart rhythm.

Just days ago, many analysts believed the drug would get approval. "We think the FDA advisory panel will be concerned that there's a 'rebound' effect with discontinuing Xarelto," Wells Fargo analysts said in a research note last Thursday. "However, our consultants do not believe this will be a deal breaker."

Here is a look at some of the other movers in healthcare during early trading on Tuesday:

Gainers (% price change) Last Trade Change Mkt Cap
Corcept Therapeutics Inc. CORT 2.71 +0.11 (4.23%) 228.19M
Curis, Inc. CRIS 2.98 +0.10 (3.47%) 228.11M
RTI Biologics Inc. RTIX 3.33 +0.11 (3.42%) 183.68M
Pharmasset, Inc. VRUS 66.30 +2.10 (3.27%) 5.00B
DUSA Pharmaceuticals, Inc DUSA 4.07 +0.12 (3.04%) 100.32M
Losers (% price change)
Protalix BioTherapeutics PLX 4.50 -0.31 (-6.44%) 385.13M
Cytori Therapeutics Inc CYTX 2.95 -0.20 (-6.35%) 158.70M
China Medical Tech., Inc CMED 5.14 -0.29 (-5.34%) 165.86M
NPS Pharmaceuticals, Inc. NPSP 6.56 -0.37 (-5.34%) 564.41M
WuXi PharmaTech (Cayman WX 12.27 -0.65 (-5.03%) 871.19M
Most Actives (dollar volume)
Johnson & Johnson JNJ 63.50 -0.57 (-0.89%) 174.01B
Pfizer Inc. PFE 18.36 -0.10 (-0.54%) 143.25B
Bristol Myers Squibb Co. BMY 29.01 +0.00 (0.00%) 49.48B
Merck & Co., Inc. MRK 31.67 -0.70 (-2.16%) 97.57B
Cephalon, Inc. CEPH 80.60 -0.01 (-0.01%) 6.28B






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