) recently announced mixed news on the pipeline front. While the
company received support from the US Food and Drug
Administration's (FDA) Central Nervous System Drugs Advisory
Committee for its insomnia candidate, suvorexant, Merck said that
it will not pursue regulatory filings for its Parkinson's disease
The company's decision regarding preladenant was based on an
initial review of data from three phase III studies which did not
show evidence of efficacy compared to placebo.
As a result, Merck decided that it will not continue with the
extension phases of these studies or pursue regulatory filings.
Results from these studies will be presented at an upcoming
Meanwhile, positive news came in the form of the FDA's
advisory panel voting in favor of approving suvorexant. Although
the FDA is not required to follow the panel's advice, it usually
does so. A response from the agency should be out by
Once it is approved, the Drug Enforcement Administration (DEA)
will assess and assign the schedule for suvorexant before it is
Merck currently carries a Zacks Rank #3 (Hold). While the
preladenant news is disappointing, we are encouraged by the
positive opinion received by suvorexant. Suvorexant belongs to a
new class of medicines called orexin receptor antagonists which
target and block orexins.
Approval would make suvorexant the first orexin receptor
antagonist to reach the market. However, we note that the
insomnia market is highly competitive and genericized especially
given the presence of generic versions of
Companies that currently look well-positioned include
Salix Pharmaceuticals, Ltd.
). Both are Zacks Rank #1 (Strong Buy) stocks.
MERCK & CO INC (MRK): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
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