Merck gets Keytruda fast-track in Japan, eyes DPP-4 market

Merck ($MRK) noted some developments in Japan central to two key drug franchises in oncology and diabetes on the Oct. 27 third quarter earnings call.

Adam Schechter, president of Global Human Health, stressed that there's a commitment to grow in the DPP-4 class abroad in diabetes.

"In the international markets, which represent nearly half of our diabetes business, Januvia franchise sales reached approximately $675 million, and grew 12%. We drove double-digit growth in Europe and emerging markets, which was partially offset by slight declines in Japan," he said.

Roger Perlmutter, president of Merck Research Laboratories, noted that Keytruda was also one of 6 drugs named by Japan for special fast-track designation.

Merck's Roger Perlmutter

"Earlier today, the Ministry of Health, Labor and Welfare in Japan announced the first set of so-called sakigake products, those given fast-track review status, which included Keytruda for the treatment of advanced unresectable gastric cancer," he said. "Clearly, the spectrum of activity of Keytruda appears to be extraordinarily broad."

On the diabetes front in Japan, MHLW granted final approval to Merck's once-weekly DPP-4 inhibitor Marizev in October and the prospects for sales growth in that market were highlighted by Schechter.

"Japan remains a very important market," Schechter said. "In fact, if you look at DPP-4 inhibitors, it's one of the few markets in the world where DPP-4 inhibitors actually have more patient days of therapy than metformin does, or sulphonylureas."

But he said that growth in that market will first have to clear a reimbursement process hurdle and noted DPP-4 sales were down about 2% in the third quarter versus prior year in Japan.

"We are launching our once weekly, and we think that could be a very important product," Schechter said. "It's on a two-week prescription limit right now, but that, over time, will be removed. And we think that that will help us potentially expand the DPP-4 class."

- here's the release

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