Merck’s big PhIII drive for diabetes drug omarigliptin grinds to a stop

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You can 86 one of Merck’s late-stage clinical catalysts for 2016. The company ($MRK) quietly put out a release late Friday saying that it has decided to drop plans to file its once-weekly DPP-4 drug omarigliptin, once seen as a key player in its late-stage pipeline.

At one stage, Merck had 9 studies going with more than 7,000 patients for the once-weekly version of Januvia, a linchpin in the pharma giant’s drug portfolio. Omarigliptin was positioned as a very similar drug with an easier dosing regimen that could help carve out market share in the hypercompetitive diabetes market. 

For Merck, omarigliptin represented a chance to help shore up eroding sales of its blockbuster Januvia/Janumet franchise, which have started to decline as competitors muscle in. That was good enough for Bernstein’s Tim Anderson to assign omarigliptin $429 million in prospective revenue for 2020, factoring in a 2016 launch. 

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Those numbers will now have to come out as Merck walks away from filing the drug for the big U.S. and European markets.

“The company will not proceed with submitting marketing applications for omarigliptin (MK-3102), an investigational, once-weekly DPP-4 inhibitor, in the United States or Europe,” Merck noted in a press release that evidently dropped right after the market closed Friday, a favorite time for burying dead drugs with a minimum of attention. “This decision did not result from concerns about the efficacy or safety of omarigliptin.” The drug is approved and sold in Japan.

While Merck isn’t saying just what objections were raised to the drug, one big hint may nevertheless come from a new report from healthcare analytics firm Advera Health Analytics, which compared head-to-head trial data on omarigliptin (sold as Marizev) and found that the weekly therapy had more serious side effects than Januvia in two studies. Marizev turned up higher rates of prostate cancer and cardiovascular and hepatobiliary issues, or problems with the liver, pancreas or digestive system, according to a report in FiercePharma today. And that could be enough to make the drug hard to market, once approved.

Whatever the case, Merck R&D chief Roger Perlmutter said it is time to switch focus to other experimental diabetes drugs, “including ertugliflozin, an investigational SGLT-2 inhibitor that we are developing in collaboration with Pfizer. We are also placing greater emphasis on our early pipeline, which includes GLP-1/glucagon co-agonists, novel insulins, and programs that employ novel mechanisms of action to improve the management of diabetes.” 

It’s not unusual for Big Pharma companies to pivot away from failure, but it is unusual to see them simply drop a Phase III drug that has been in the clinic for years. It is not, however, unheard of. Just two weeks ago Johnson & Johnson ($JNJ) punted its big Phase III program for an anti-NGF pain drug called fulranumab, which was steered back into human studies after a safety scare put the whole field on ice for several years.

- here's the release

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