The fourth time proved to be the charm for Merck & Co. ($MRK) on sugammadex, the anesthesia-reversal drug that won FDA approval Tuesday. Rejected three times before, the drug will be sold under the brand name Bridion, and targeted at hospitals.
The question now is whether potential side effects will deter doctors, hampering Bridion's long-awaited debut on the U.S. market. Merck is counting on the drug to beef up its hospital-focused business, which executives have tagged as one of four major growth opportunities for the company.
Used to reverse the effects of neuromuscular-blocking drugs that freeze vocal cords and muscles during surgery, Bridion allows patients to come off breathing machines and go back to breathing on their own sooner, the FDA says. But the agency warned doctors to monitor for slowing heart rates that could trigger cardiac arrest and to keep an eye out for signs of severe allergic reactions that could be fatal.
Bridion is already used in dozens of other countries, despite the potential side effects, and as FierceBiotech reports, some analysts believe the FDA nod could fuel a big increase in sales--past the $700 million mark.
Others aren't convinced, with some consensus estimates pegged at $210 million. Thomson Reuters' analyst poll came up with a more optimistic figure of $557 million at peak.
Bridion will join the lineup of Merck's hospital drugs, which also includes the high-powered antibiotics it acquired along with Cubist Pharmaceuticals in an $8.4 billion deal last year. The hospital business brought in $985 million during the third quarter and $2.5 billion for the first 9 months of this year. Bridion delivered $262 million of that 9-month total, up slightly from $245 million for the same period of 2014.
|Merck's Adam Schechter|
The company is marketing the hospital range together, using its stronger or more entrenched drugs to help pump up the newer or slower-growing products. Bridion and the former Cubist drug Entereg make up the surgery and post-op slice of the product line. "We drove growth for Bridion in a portfolio of antibiotic and antifungal treatments," said Adam Schechter, Merck's president of global human health, during the quarterly earnings call. "We continue to see this segment as a growth driver."
A couple of other drugs have joined that lineup over the past year or so; the Cubist pipeline med Zerbaxa scored an FDA nod last December, with estimates of $560 million in sales by 2018. But the business faces a setback on Cubicin, its top seller; last month, an appeals court backed only one of the drug's 5 patents, and that one expires in June. Drugmakers such as Hospira, now owned by Pfizer ($PFE), are revved up to launch copycat versions. Merck says it's weighing further legal action, including an appeal to the U.S. Supreme Court.
- see the release from the FDA
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