FDA asks Merck for more data on its new combination cholesterol drug

FDA asks Merck for more data on its new combination cholesterol drug

March 6th, 2012 // 1:46 pm @

Merck & Co. is trying to improve its place in the cholesterol drug market but its latest attempt faces another hurdle.

The U.S. Food and Drug Administration, according to Merck, said the company needed to provide more data before the agency could further consider an application for a new drug that combines Merck’s cholesterol drug Zetia and a generic version of Pfizer Inc.’s Lipitor.

So many people’s arteries are clogged with cholesterol-produced plaque that drug companies are looking for ways to retain revenue from established drugs, ward off generic competitors, and try new combinations that might yield future profits.

“We think that there is an opportunity for Zetia in the marketplace, particularly with generic Lipitor,” Adam Schechter, Merck executive vice president and president of global human health, said in a conference call with analysts on Feb. 2.

The drug combination is meant for people with especially high cholesterol.

“Merck 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 may address the FDA’s comments,” Merck said in a statement. It has large operations in the Philadelphia region.

Clinical studies involve a tablet that combines ezetimibe and atorvastatin, the generic names of Zetia and Lipitor, respectively. The combination does not have a brand name, though it has been in the works since 2007.

Zetia works in the digestive tract to inhibit the absorption of cholesterol, while other cholesterol-reducing drugs called statins work in the liver. Lipitor is a statin.

Merck’s Vytorin combines Zetia and the generic version of its own statin, Zocor (simvastatin). But Vytorin sales decreased 7 percent in 2011 to just under $1.9 billion, according to Merck.

Zetia’s global sales in 2011 grew to $2.4 billion, an increase of 6 percent. Merck’s best-selling product is the respiratory drug Singular, with $5.5 billion in sales in 2011, followed by the diabetes treatment Januvia at $3.3 billion.

The FDA is not Merck’s only hurdle in this project.

Pfizer sued Merck in 2011, alleging the combination drug would infringe on Pfizer’s Lipitor patents. Though it lost exclusive patent protection of Lipitor in the U.S. in November, Lipitor had $9.6 billion in global sales in 2011.

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