April 10, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Kenilworth, N.J.-based Merck & Co. has yet to see much value from its $50 billion buyout of Schering-Plough in 2009, as the company is expected to get yet another rejection later this month from the U.S. Food and Drug Administration (FDA) for its perennial failure sugammadex, also sold as Bridion.
“It wasn’t supposed to be this way,” wrote columnist Peter Loftus over at the Wall Street Journal‘s Pharmalot blog on Friday. “You might remember Bridion as one of five drugs, or ‘stars,’ in the research pipeline at Schering-Plough.”
Those stars have now apparently dimmed. Originally listed as antipsychotic Saphris; anticlotting drug vorapaxar; rheumatoid-arthritis therapy golimumab (with Johnson & Johnson; hepatitis C drug boceprevir; and Bridion. But now, six years later, its clear that almost all have either had much lower sales than expected (Bridion, Saphiris) or been parceled off (golimumab during a contract dispute).
“Well, that five-star constellation hasn’t shined as brightly as originally expected, as the Bridion experience illustrates,” wrote Loftus. “But at least one other pipeline drug from the Schering deal has emerged from the dark matter as an unexpected bright spot—and there could be more.”
Now, all Merck can do is look towards some “hidden gems” in that former pipeline, including cancer drug Keytruda, approved by the FDA in September, or experimental Alzheimer’s disease drug MK-8931.
Merck struggle with Bridion has been Sisyphean at best. The company said last month that the 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. (MRK) “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. (GILD)’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 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 last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
