Vertex Pharmaceuticals Inc. (
recently received a notice from the U.S. Food and Drug
Administration (FDA) informing the company about a partial
clinical hold on Vertex Pharma's ongoing phase II U.S. study of
its hepatitis C virus (HCV) candidate, VX-135. The news had a
negative impact on the company's stock price.
Vertex Pharma discontinued the 400 mg arm of the phase II
study of VX-135 in combination with ribavirin in Europe as
elevated liver enzymes were observed. Following this observation,
the FDA put a clinical hold on the 200 mg dose of VX-135 in
combination with ribavirin in a study in the U.S. The FDA has
asked Vertex Pharma to submit additional clinical, preclinical
and pharmacokinetic data in the fourth quarter. VX-135 is also
being evaluated in a 100 mg dose in combination with ribavirin in
a study in the U.S. This study will be continued as planned and
data is expected in the second half of 2013.
Besides this, Vertex Pharma also provided updates on other
all-oral studies conducted on VX-135.
Dosing of 100 mg and 200 mg of VX-135 in combination with
ribavirin as part of the 12-week, phase II study in Europe was
recently completed. Both doses were well tolerated with no
serious adverse events identified. Complete data is expected by
Dec 31, 2013.
Recently, as part of a phase II study, in New Zealand, 100 mg
and 200 mg doses of VX-135 in combination with
Bristol-Myers Squibb's (
daclatasvir were initiated. Data from this study is expected in
VX-135 is also being evaluated in a drug-drug interaction
clinical study in combination with
Johnson & Johnson's (
Vertex Pharma carries a Zacks Rank #3 (Hold). Right now,
Jazz Pharmaceuticals Public Limited Company (
looks well positioned with a Zacks Rank #1 (Strong Buy).
BRISTOL-MYERS (BMY): Free Stock Analysis
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