Merck's fast and furious MK-3475 immunotherapy team guns for a quick approval

Merck R&D chief Roger Perlmutter

Roger Perlmutter has made no secret of the fact that he plans to rapidly execute on the pharma giant's closely watched PD-1 cancer program for MK-3475. The new R&D chief at Merck ($MRK) has carved out the resources and the team needed to put the drug on the shortest path possible to the FDA. And today he spelled out plans to launch a rolling submission to the agency in a race to complete its application in the first half of this year.

"Initiation of this rolling submission represents an important milestone in the MK-3475 clinical development program for patients suffering from malignant melanoma," Perlmutter said in a statement.

More important, perhaps, is the drug's potential for rehabilitating the reputation of an R&D organization that earned considerable criticism for its slow-motion research efforts under Peter Kim. MK-3475 quickly emerged as one of the pharma giant's--and Perlmutter's--hottest prospects. Merck engineered an early-stage study with more than 1000 patients and earned breakthrough status at the FDA. Now it plans to prove that it has what it takes to really hustle, pushing for a landmark approval in a race against Bristol-Myers Squibb ($BMY) and Roche ($RHHBY).

MK-3475 is in three studies for advanced melanoma, including a late-stage head-to-head study that pits the experimental therapy against ipilimumab.

ISI's Mark Schoenebaum called the regulatory news from Merck "encouraging," adding that a bigger opportunity awaits Merck in lung cancer and for other tumors. MK-3475 has produced some startling results in the clinic, working on the theory that if you can take the biological foot off the immune system's brakes, you can fundamentally change the way cancer is treated.

Merck has now clearly marked the goal posts on clinical development. It should be interesting to see how Roche and BMS respond.

- here's the statement

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