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Merck & Co says Januvia follow-up looking good

Diabetes drug shows promise in phase II as once-weekly treatment

Merck & Co has reported positive phase IIb data with experimental diabetes drug MK-3102 suggesting it could be a valuable addition to its $6bn-a-year diabetes franchise headed by Januvia.

MK-3102 is a dipeptidyl peptidase-4 (DPP-4) inhibitor - in the same class as Januvia (sitagliptin) - but has a profile which suggests it could be dosed just once a week rather than once-daily.

The new compound significantly lowered blood sugar in a 12-week study compared with placebo, with an incidence of symptomatic hypoglycaemia that was similar to placebo, according to data presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany.

The 685-patient study tested a range of doses of MK-3102 - from 0.25mg to 25mg - given over a 12-week period.

The results showed that levels of HbA1c - a measure of blood glucose levels over time - were reduced in a dose-dependent manner and at all doses tested were significantly improved compared to control.

At 25mg per week the benefits of the drug on blood glucose were equivalent to that seen in Januvia's studies, and Merck said it would take this dose forward into phase III trial both as a monotherapy and in combination with other anti-diabetic drugs, according to a Reuters report.

Januvia is the market leader in the DPP-4 category, which also includes Novartis' Galvus (vildagliptin), Eli Lilly/Boehringer Ingelheim's Tradjenta (linagliptin), AstraZeneca and Bristol-Myers Squibb's Onglyza (saxagliptin), and Victoza (liraglutide) from Novo Nordisk.

In the first six months of 2012 Januvia and line extension Janumet (sitagliptin plus metformin) added a little under $2bn and $1bn, respectively, and could see additional momentum added to an already-impressive growth rate if the results of the TECOS cardiovascular outcome study in diabetics - due in 2014 - prove positive. Some analysts have predicted that the franchise could reach $12bn at peak.

The favourable dosing of MK-3102 could see it carve another large slice of the type 2 diabetes market, given that DPP-4 inhibitors are predicted to overtake sulfonylureas as the biggest single drug class in the oral category within the next few years.

4th October 2012

From: PME

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