Regulatory Setback for Merck - Analyst Blog


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The FDA has issued a complete response letter for Merck's ( MRK ) 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 FDA's requirements.

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 Roche ( RHHBY ), Bayer ( BAYRY ) and Novo Nordisk ( NVO ) look attractive. While Roche is a Zacks Rank #1 (Strong Buy) stock, both Bayer and Novo Nordisk are Zacks Rank #2 (Buy) stocks.

BAYER A G -ADR (BAYRY): Free Stock Analysis Report

MERCK & CO INC (MRK): Free Stock Analysis Report

NOVO-NORDISK AS (NVO): Free Stock Analysis Report


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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