The FDA has issued a complete response letter for
) resubmitted New Drug Application for sugammadex sodium
injection. Merck is looking to get sugammadex approved in the
U.S. for the reversal of neuromuscular blockade (NMB) induced by
rocuronium or vecuronium.
The CRL issued by the FDA has raised concerns regarding the
operational aspects of a hypersensitivity study that the agency
had asked the company to conduct. 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.
Then, this year, the FDA had cancelled an Anesthetic and
Analgesic Drug Products Advisory Committee (AADPAC) meeting which
was scheduled to be held on Jul 18. The agency had said that it
needs more time to evaluate the results of a recently completed
inspection of a clinical trial site. The site was one of four
sites where the hypersensitivity study was conducted as per the
Merck is currently evaluating the CRL and will determine the
future regulatory path. The delay in sugammadex' approval is
disappointing. Sugammadex, however, is marketed in more than 50
countries other than the U.S. under the trade name Bridion.
Bridion sales were $261 million in 2012, up 29.9%.
The sugammadex CRL is the second one to be received by Merck
in the recent past. In Jul 2013, the company received a CRL for
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
) look attractive. While Roche is a Zacks Rank #1 (Strong Buy)
stock, both Bayer and Novo Nordisk are Zacks Rank #2 (Buy)
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