) recently announced that its New Drug Application (NDA) for its
anti-thrombotic candidate, vorapaxar, was accepted by the U.S.
Food and Drug Administration (FDA) for standard review.
Merck is looking to get vorapaxar approved in the U.S. for the
secondary prevention of cardiovascular events in patients with a
history of heart attack and no history of stroke or transient
ischemic attack (TIA). With the FDA granting standard review, a
response should be out in the first half of 2014.
We note that Merck recently suffered a pipeline-related
setback with the FDA cancelling an advisory panel meeting for
sugammadex. Merck is looking to get sugammadex approved for the
reversal of neuromuscular blockade (NMB) induced by rocuronium or
Merck said that the FDA cancelled the Anesthetic and Analgesic
Drug Products Advisory Committee (AADPAC) meeting which was
scheduled to be held on July 18. The agency said that it needs
more time to evaluate the results of a recently completed
inspection of a clinical trial site. The site is one of four
sites where a hypersensitivity study was conducted as per the
Merck is currently in discussions with the FDA regarding the
path forward. The delay in sugammadex's approval is
disappointing. We note that Merck had failed to gain U.S.
approval for sugammadex earlier in 2008. At that time, the FDA
had asked for additional data related to hypersensitivity
reactions and bleeding events.
Sugammadex, however, is marketed in 40 countries other than
the U.S. under the trade name Bridion. Bridion sales were $261
million in 2012, up 29.9%.
The delay in sugammadex's U.S. approval is the second
regulatory setback for Merck this month. Earlier in July, Merck
had received a complete response letter (CRL) from the agency for
its insomnia candidate, suvorexant.
Merck currently carries a Zacks Rank #3 (Hold). The company
has been facing headwinds in the form of Singulair's loss of
exclusivity, unfavorable currency movement and pipeline setbacks.
We believe Merck will look towards cost-cutting initiatives and
share buybacks to drive the bottom-line.
At present, companies like
Johnson & Johnson
) look well-positioned. While Jazz is a Zacks Rank #1 (Strong
Buy) stock, Johnsons & Johnson and Auxilium are Zacks Rank #2
AUXILIUM PHARMA (AUXL): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
MERCK & CO INC (MRK): Free Stock Analysis
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