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Bayer, Onyx launch Phase III trial of Nexavar to treat lung


dadstimeon

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drug UPDATE

http://www.forbes.com/business/feeds/af ... 32309.html

02.16.2006, 11:11 AM

(updating to add further details)

FRANKFURT (AFX) - Bayer AG said it and its partner Onyx Pharmaceuticals Inc are launching a phase III trial of their drug Nexavar to treat non-small cell lung cancer in combination with chemotherapeutic agents carboplatin and paclitaxel.

The company previously said this indication will raise peak sales potential for Nexavar, previously known as Sorafenib, to more than 1 bln eur.

Some 900 patients are expected to enrol in the randomised, double-blind, placebo-controlled phase III study, which is to be conducted at more than 130 sites in North America, South America, Europe and the Asia Pacific region.

The two companies also said the US Food and Drug Administration has completed a Special Protocol Assessment (SPA) for the NSCLC trial.

An SPA is a written agreement on the design and size of clinical trials that is intended to form the basis of a new drug application.

There are nearly 175,000 new cases of lung cancer in the United States each year, of which about 75 pct are due to NSCLC.

Annual deaths in the US due to lung cancer are estimated at 160,000, according to Bayer.

maria.sheahan@afxnews.com

ms/joy/har

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