Merck's ($MRK) new, once-a-week treatment for diabetes measured up to the company's top-selling Januvia in its first Phase III test, setting the stage for a Japanese regulatory application and stoking the drugmaker's hopes of another blockbuster in the space.
In a Japanese study on 414 patients with Type 2 diabetes, Merck's omarigliptin (MK-3102) significantly beat out placebo in lowering blood glucose levels at 24 weeks, proving itself noninferior to the daily Januvia, which brought in $4 billion for the company last year. The two drugs, which work by blocking a protein called DPP-4, charted similar safety profiles in the study, Merck said, and both had similar rates of adverse events as the placebo arm.
The Phase III success marks the first victory in Merck's sweeping late-stage program for omarigliptin, which includes 10 Phase III studies involving about 8,000 patients. The trial results will support a Japanese filing by year's end, the company said, and Merck hasn't disclosed a U.S. timeline for its weekly treatment.
Omarigliptin is a major pillar of Merck's growing ambition in diabetes, as the company works to build a portfolio around the slowly receding Januvia. Last year, the New Jersey giant struck a $60 million deal with rival Pfizer ($PFE) to get its hands on the Phase III ertugliflozin, which works by forcing excess glucose out through the urine. That drug holds promise as a monotherapy, Merck said, but its brightest future may come as a fixed-dose partner to a DPP-4 blocker. The company has also shouldered its way into the diabetes biosimilar world with the late-stage MK-1293, a knockoff of Sanofi's ($SNY) $8 billion-a-year Lantus (insulin glargine).
But despite its leadership in DPP-4, Merck is holding up the rear among Big Pharmas competing in diabetes.
Novo Nordisk's ($NVO) daily Victoza injection, which works by amping up the hormone GLP-1 to spur insulin production, banked $2 billion in 2013 and is only expected grow. And the market is further crowding as GlaxoSmithKline ($GSK) launches its GLP-1 contender Tanzeum (albiglutide) and Eli Lilly ($LLY) awaits approval for dulaglutide, the only weekly offering that has measured up to Novo's once-a-day leader in pivotal studies. Meanwhile, Sanofi is at work on a moonshot approach to the space, this week disclosing plans to develop an oral GLP-1 therapy.
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