Merck has filed an innovative new diabetes treatment with the US regulator, and hopes the drug could be one of its major products of the future.

Januvia (sitagliptin phosphate) is one of a new class of drugs called DPP-4 inhibitors that enhance the body's incretin system, which lowers blood glucose when it is elevated.

The drug could be a step forward for treatment of type II diabetes, but a number of new treatments have failed in late stage development in recent years, with Merck suffering more than most.

The company suffered a major blow in late 2005 when the FDA demanded extensive additional safety data for another of its type II diabetes drugs, muraglitizar. The company and its co-developer Bristol-Myers Squibb now look likely to scrap the drug, which analysts had forecast for $1 billion plus peak sales.

Merck will hope Januvia can pick up the baton in diabetes, with analysts forecasting peak annual sales of around $1.4 billion, but the drug will face competition from a rival DPP-4 inhibitor.

Novartis' LAF-237 is in the same class and is also in phase III trials, and is expected to be filed later this year.

The drugs will not only be compared in terms of their effect on blood glucose, but also whether or not they cause weight gain or lower lipids.

Merck said its clinical studies of Januvia showed no sign of weight gain from baseline, and an incidence of hypoglycaemia similar to placebo, with no serious side-effects.

Novo Nordisk is hoping its drug can challenge Lilly's because of a number of claimed advantages, including a once rather than twice a day injection, with no peak in its action.

Another new class of diabetes drugs, called GLP-1 analogues, are also being developed. These include Lilly's Byetta, launched in 2005, and Novo Nordisk's liraglutide, currently in phase II development.

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Monday , January 16, 2006

pharmafocus@wiley.co.uk