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Lilly diabetes pill recommended for EU approval

June 24, 2011

Eli Lilly and Co. and Boehringer Ingelheim GmbH’s Trajenta medicine for Type 2 diabetes has been recommended for approval in Europe, putting the drug on track to enter the region’s market this year.

The European Medicines Agency’s Committee for Medicinal Products for Human Use said Trajenta should be used in patients whose diabetes can’t be controlled by diet and exercise alone and who can’t take the older medication metformin, Boehringer said in a statement Friday.

Known chemically as linagliptin, the pill was approved in May by regulators in the U.S., where it’s marketed under the spelling Tradjenta. The drug is among four diabetes treatments Indianapolis-based Lilly and Ingelheim, Germany-based Boehringer agreed in January to develop and sell jointly, sharing equally in costs and margins from the products.

The drug can be an “important new treatment option” for patients with Type 2 diabetes, Enrique Conterno, president of Lilly’s diabetes division, said in the prepared statement.

The Boehringer partnership may contribute to earnings by 2014, Lilly said when the deal was announced. Sales of each drug may be about $2.84 billion, and combined peak sales may reach $14.2 billion, Engelbert Tjeenk Willink, the Boehringer executive responsible for human pharmaceutical products’ sales and marketing, said at the time.

More than 220 million people worldwide have diabetes, and about 90 percent have the Type 2 version, according to the World Health Organization. Obese people are among the most at risk for the disease, which prevents the body from using insulin properly to control blood glucose levels. Left untreated, Type 2 diabetes can lead to heart attack, stroke and blindness.

The European Medicines Agency, based in London, provides initial regulatory authorization for treatments from companies seeking regionwide approval in all European Union countries plus Iceland, Liechtenstein and Norway. The European Commission, the EU’s executive arm, gives final approval based on the agency’s recommendation.

Lilly stock fell 29 cents Friday morning, to $36.90 per share.

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