March 16, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Kenilworth, N.J.-based Merck & Co. announced Friday that the U.S. Food and Drug Administration (FDA) had canceled its March 18 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee. The meeting had originally been expected to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection.
Sugammadex injection is an investigational compound reverses neuromuscular blockade induced by rocuronium or vecuronium. In other words, sugammadaex reverses the effects of several anesthetics after surgery. It has been approved in more than 50 countries under the name Bridion.
In 2008 the FDA rejected sugammadex because of concerns about allergic reactions and bleeding. In the most recent statement, the FDA said it planned to conduct more site inspections related to a 2008 hypersensitivity study known as Protocol 101. Friday’s announcement indicated that Merck & Co. “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.”
The drug has pulled in $340 million in 2014 sales. Approval in the U.S. is projected to bring in annual sales of $550 million in 2020.
In 2013 the FDA sent Merck a Complete Response Letter regarding a resubmission of the NDA for sugammadex. In this letter the FDA expressed concerns about operational aspects of the hypersensitivity study the FDA had requested in 2008.
“We believe sugammadex is an important innovation,” said David Michelson, head of Merck’s global neuroscience clinical development in a statement at the time, “and will work closely with the FDA to bring this product to hospitals, surgeons, anesthesia professionals and patients in the United States.”
Merck appears to be off to a rough start this year. Earlier in February, the FDA announced it was dropping its breakthrough therapy designation for Merck’s Hepatitis C treatment of grazoprevir/elbasvir (MK-5172/MK-8742), which would compete with Gilead Sciences, Inc. ’s Harvoni and AbbVie’s Viekira Pak. Those two companies appear to be in an intense price war over their own Hepatitis C drugs.
Alternately, Merck has been working to streamline its research and development processes and refocus on the immuno-oncology and Hepatitis C markets. Its diabetes business is also strong. Analysts suggest that the company’s Hepatitis C drug may still be competitive and new approvals for cancer drug Keytruda are promising. Keytruda has been approved for the treatment of advanced melanoma and is projected to bring in as much as $5 billion annually if it can slip into the U.S. and European market pools.
BioSpace Temperature Poll
After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? Tell us your thoughts.
