Merck eyes opportunity for omarigliptin filing with Japan's PMDA

Merck's ($MRK) July 28 second-quarter earnings call said bon voyage to Joseph Romanelli, vice president of investor relations, as he heads over to run Hong Kong and Taiwan as managing director. It also included a bit about filing plans in Japan and the outlook for China.

His replacement to handle investor relations is Teri Loxam.

Of note from Roger Perlmutter, executive vice president for Merck Research Laboratories, was that the company had "good discussions" with Japan's Pharmaceutical and Medical Devices Agency (PMDA) regarding our filing for omarigliptin, a once weekly DPP-4 inhibitor for the control of hyperglycemia in patients with type 2 diabetes.

But he did not give a timeframe for Japan with U.S. filing for approval of omarigliptin in the United States seen before the end of the year.

Adam Schechter, executive vice president for Global Human Health, also provided some figures on the Japan business of particular interest because they compare to a second quarter there last year that saw a sales tax hike crimp business for companies across the board. He also gave some detail on overall emerging markets and China.

"Japan sales declined 13% primarily from ophthalmology product divestitures and declines in older diversified products," Schechter said. "Pneumovax grew on a continued rollout of a national immunization program. Emerging markets sales grew 4%. If you exclude divestitures, sales would have grown 6%. China grew 8% this quarter driven by sales increases in Hospital Acute Care."

Schechter discussed China overall in response to a question from UBS analyst Marc Goodman, and like other companies before noted that a slowdown is evident.

"If you look at China, we had 8% growth and we saw growth across our hospital acute care business and diversified brands, he said.

"There is no doubt that we are seeing some macro trends of a slowdown, but I still believe there's significant opportunity there. We have good traction with multiple key products that we have, the products that you would think of, but we are also pursuing innovation and we are looking forward to having NRDL (National Reimbursement Drug List) pricing approval for products like Januvia and Zetia in the future, which I think could be growth drivers for us in that market. So despite the macro trends, I do believe over time that China can remain an important market for us."

- here's the Merck earnings release