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FDA asks for more data on Merck & Co's Zetia combo

While allergy immunotherapy clears phase III trial

The US FDA says it needs additional data before it can approve Merck & Co's new cholesterol-lowering drug MK-0653c, which combines its Zetia (ezetimibe) drug with generic atorvastatin.

The marketing application looks set to be delayed by a year or more as the agency has requested an additional clinical trial of the combination product. Meanwhile, a lawsuit filed by Pfizer, which sells the original Lipitor brand of atorvastatin, could delay a launch for even longer.

MK-0653c represents an attempt by Merck to inject some new momentum into its flagging ezetimibe franchise, which after a buoyant start has seen sales slide.

Merck said it plans to discuss next steps with the agency in the near future, including new data that are expected to be available later this year, which the company believes may address the FDA's comments.

Last year, Zetia saw its sales growth flatten to 2 per cent, bringing in $2.4bn in revenues, while Vytorin, a combination of ezetimibe with older statin drug simvastatin, shrank 7 per cent to $1.88bn.

Merck has been hoping that the inclusion of top-selling atorvastatin in MK-0653c would create a more powerful cholesterol-lowering drug and help patients with high cholesterol achieve greater reductions.

Analysts have suggested that MK-0653c could add another $500m to the franchise within three years of launch.


Allergy immunotherapy clears phase III trial

Meanwhile, there was better news for Merck after a phase III trial of its allergy immunotherapy tablet (AIT) for ragweed pollen allergy generated positive results, setting up a regulation submission in 2013.

The study results showed that the use of ragweed AIT significantly reduced a combined score that measured nasal and eye symptoms and use of rescue allergy medicines, compared to placebo, in ragweed-allergic adults with or without asthma.

Merck is also developing an AIT against grass pollen allergy which could also be filed in 2013. The company licenses US, Canadian and Mexican rights to the AITs from Denmark-based ALK Abello.

6th March 2012

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