Business Briefs: Merck, CMS and Sucampo

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Merck today gained fast-track status for lambrolizumab, a drug being developed for advanced skin cancer. FDA designated the experimental treatment as a “breakthrough therapy.” Mid-stage trials are in progress to determine the drug's efficacy and safety profile. FDA's new breakthrough status is meant to give treatments which could potentially treat an unmet need a faster pathway to approval. Gary Gilliland, SVP and oncology franchise head for Merck's research division, noted: “It opens up opportunities and lines of communication with the agency for creative ways to move development forward as quickly as possible,” as reported by the Wall Street Journal.

Marilyn Tavenner received a nod from the Senate Finance Committee yesterday, but then this afternoon saw her appointment indefinitely blocked by Sen. Tom Harkin (D-Iowa), reported. Harkin's spokeswoman declined to specify why he blocked Tavenner's next step, a full Senate vote, but alluded to concerns raised at an earlier hearing. CMS has not had a confirmed head since Mark McClellan left in October 2006.

A new survey from Ernst & Young, reported by Pharmalot, says biotechs are not doing enough to win over payers. While 60% of respondents cite payers as being very important, most of the executives who responded indicated that they were more focused on achieving efficiencies than catering to payers. Only 11% of respondents said they have added payer or reimbursement expertise to their management teams. In addition, 45% noted that it was unlikely that they would add someone with payer or reimbursement expertise to their management team. That said, only 21% said they would discontinue product candidates which do not exceed the current standard of care.

Sucampo's Amitiza was cleared for an additional indication today. The treatment's uses were expanded to now include opioid-induced constipation in patients with non-chronic cancer pain. Amitiza is now the first oral drug available for opioid-induced constipation. Cantor Fitzgerald Analyst Irina Rivkind, as reported in Bloomberg, estimated this new indication will create a market opportunity of $200 million. The American Journal of Gastroenterology noted in May 2011 that 40% of patients on opioids experience constipation.

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