Merck (MRK - Analyst Report) 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 vecuronium.
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 FDA’s requirements.
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 (JNJ - Analyst Report) , Auxilium Pharmaceuticals and Jazz Pharmaceuticals (JAZZ - Analyst Report) look well-positioned. While Jazz is a Zacks Rank #1 (Strong Buy) stock, Johnsons & Johnson and Auxilium are Zacks Rank #2 (Buy) stocks.