Merck can't get the sugammadex curse lifted, faces 3rd FDA rejection

Merck's anesthesia drug sugammadex has been cited repeatedly over the years as one of the top experimental meds in the pharma giant's ($MRK) pipeline, a trophy obtained in its megamerger with Schering. But the treatment has racked up a painful series of setbacks over the years, starting with its first rejection at the hands of the FDA 7 years ago and continuing now with a third looming rejection over unresolved questions surrounding a hypersensitivity study performed for its pitch to the agency.

After the markets closed on Friday, Merck put out a brief announcement saying that the FDA had decided to scrap an advisory committee review of sugammadex slated for next week.

"The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101)," noted Merck. "The agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review."

The news comes 21 months after the FDA scrapped the last adcomm meeting for sugammadex, citing the agency's desire to review a site involved in the troubled hypersensitivity study. Even with 7 years of discussions and applications with the FDA, Merck still can't overcome the agency's concerns about the allergic reactions that triggered the first rejection.

Merck's second rejection for this therapy in 2013 came during a particularly fallow period for the pharma giant, serving as a painful reminder of its inability to score significant new drug approvals. Roger Perlmutter's arrival as R&D chief, followed by Merck's big OK for the immuno-oncology drug Keytruda, helped dispel the bad rep that triggered a major R&D reorganization. But Perlmutter recently vowed--incorrectly--that sugammadex was back on track. The R&D chief also had to deal with the agency's decision to strip breakthrough drug status for a closely-watched hep C program now that the first two game-changing therapies from Gilead ($GILD) and AbbVie ($ABBV) are already on the market. Perlmutter clearly found that a bitter pill to swallow. And Bristol-Myers Squibb ($BMY) recently leapfrogged Merck with its IO drug Opdivo, gaining a stunningly fast approval for lung cancer--a big market in the field.

Add it all up, and Merck's big R&D operation has had a rough start to the year.

- here's the release

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