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Data support MSD's Januvia diabetes treatment

New data presented at the American Diabetes Association (ADA) have shown that MSD's diabetes treatment Januvia improves glycaemic control

New data presented at the American Diabetes Association (ADA) 67th Annual Scientific Sessions on 25 June have shown that Merck, Sharp & Dohme's (MSD) diabetes treatment Januvia (sitagliptin) improves glycaemic control and has a favourable tolerability profile as add-on therapy over one year.

Januvia is the first dipeptidyl peptidase-4 (DPP-4) inhibitor available in the UK as an add-on therapy to metformin or a thiazolidinedione (TZD), in patients with type 2 diabetes when the single agent alone plus diet and exercise do not provide adequate glycaemic control. It is a novel approach to treating type 2 diabetes, working with the body's own way of controlling blood glucose.

The study examined the tolerability and efficacy of Januvia, when added to metformin in an extension to a phase III trial giving 54 weeks of data. It concluded that sitagliptin leads to clinically meaningful and significant reductions in glycated hemoglobin and fasting plasma glucose. The data also demonstrated a low incidence of hypoglycaemia and a low risk of weight gain.

Professor Anthony Barnett, Professor of Medicine, Birmingham Heartlands & Solihull NHS Trust, comments: "Sitagliptin is the first in a new class of type 2 diabetes medicines available in the UK and these new data provide further evidence that this treatment provides substantial glucose lowering for patients with type 2 diabetes and has a good side-effect profile."

The FDA approved Januvia in the US in October 2006 and could be a blockbuster. Raymond James analysts say that US sales will exceed USD 500m (EUR 367.1m) in FY07 and could reach an annual peak of USD 2.5bn (EUR 1.8bn).

Galvus hot on Januvia's heels
Januvia faces competition from Novartis' Galvus (vildagliptin), as both are similar in many ways, including their once daily pill form and ability to lower blood-sugar levels in diabetics while helping them to lose weight.

Galvus' road to approval has been far from smooth, however, as the FDA delayed its decision on the drug and called for more data, including a further clinical study to show its safety and efficacy in patients with kidney impairment.

New data presented in June 2007 at the annual American Diabetes Association meeting in Chicago, showed that Galvus demonstrated efficacy and tolerability both as a monotherapy and when added to many commonly used diabetes medicines.

No evidence has been seen of overall weight gain or dangerously low blood sugar levels, side effects commonly associated with some type 2 diabetes medications, in the Galvus clinical programme, Novartis has said.

A G Edwards analysts project that Galvus global sales could top USD 1.7bn (EUR 1.3bn) by 2011, with Januvia sales reaching USD 2bn (EUR 1.5bn) in the same year.

4th July 2007

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