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Januvia approved in the EU

Merck & Co's diabetes drug Januvia has been approved for two additional uses by the European Commission.

Merck & Co's diabetes drug Januvia has been approved for two additional uses by the European Commission.

Januvia is now the only DPP-4 inhibitor approved as an add-on therapy to a sulphonylurea (dual therapy) or a sulphonylurea plus metformin, and is the only DPP-4 inhibitor indicated for once-daily use. 

Januvia is the first in a new class of diabetes drugs which enhance the body's mechanisms for regulating blood sugar. 

Januvia posted sales of USD 185m in Q3 FY07. 

Januvia beat rivals to market by winning FDA approval in 2006 and EU approval in March 2007 for the treatment of type 2 diabetes in combination with either metformin or, in certain patients, with a PPAR? agonist (i.e. thiazolidinedione) when diet and exercise plus either agent do not provide adequate glycaemic control. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 

Januvia has been gaining prescriptions at the expense of GlaxoSmithKline's (GSK) Avandia (rosiglitazone), which has been linked to increased heart attacks, and a delay in US approval for Novartis' diabetes drug, Galvus (vildagliptin).

This is good news for Merck, which is relying on sustained growth of its key drugs such as cervical cancer vaccine Gardasil, Januvia, and asthma drug Singulair (montelukast), to combat generics competition in other areas of its portfolio. 

Merck & Co is targeting pre-tax savings of USD 4.5-5bn from 2006 through 2010, of which USD 2bn will be through the implementation of a manufacturing supply strategy.

The company will meet its target of cutting 7,000 jobs by the end of 2008. It already axed 6,000 positions by the end of September 2007.

The savings and projected sales growth should enable Merck & Co to return its gross margin, starting in 2008, to levels consistent with those seen prior to the loss of US patent exclusivity for Zocor (simvastatin).

22nd January 2008

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