Merck's Januvia powerhouse could feel the heat from device challenger

Merck & Co. ($MRK) has encountered a few roadblocks in recent years with its diabetes drug, Januvia as safety concerns took a bite out of sales. The company has worked hard to reverse this trend, and recently unveiled data on heart safety could do its part. But now Merck could be facing another threat, and not from a regulator or competing drugmaker--but a devicemaker.

Boston-based Intarcia is touting data showing its tiny, implantable drug pump worked better in a head-to-head comparison with Merck's top-selling Januvia, The Boston Business Journal reports. In a trial of 535 people with Type 2 diabetes, Intarcia's ITCA 650 implant reduced a type of hemoglobin linked to the disease twice as much as Merck's drug, and also spurred about four times the weight loss in patients.

The numbers could mean big things for Intarcia, which is trying to make its implant the new standard of care for Type 2 diabetes patients, a feat that would require it to unseat Januvia and other top treatments, CEO Kurt Graves told the BBJ earlier this year. The company plans to file for FDA device approval during the first half of 2016.

And that means the device could interfere with Merck's plans to reap top sales from the Januvia franchise in the years before its U.S. patent expires in 2022. The drug brought in more than $6 billion in revenue last year along with combo pill, Janumet, making it the company's best-selling franchise.

In the meantime, Merck could well capitalize on a boost from new safety data. Earlier this year, researchers revealed that the drug passed a critical heart safety test. According to results from the TECOS trial released at the American Diabetes Association meeting in June, there was no link between Januvia and heart failure in patients.

The way Bernstein & Co. analyst Tim Anderson figures, this could mean big things for sales. The data could boost 2020 numbers for Januvia and Janumet by up to 10%, Anderson said at the time, helping the drugs achieve $7.3 billion in sales. And the numbers could also give the drug more of a lead against AstraZeneca's ($AZN) rival med, Onglyza, which flagged higher numbers of heart failure hospitalizations in patients in outcomes trial testing.

- read the BBJ story

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