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UPDATE 1-Merck's Erbitux gets green light for head cancer

Fri Oct 24, 2008 7:13am EDT

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FRANKFURT, Oct 24 (Reuters) - A committee of experts advising the European Commission said on Friday it backed Merck KGaA's (MRCG.DE) Erbitux drug for a second use to combat head and neck cancer, bolstering its sales potential in the region.

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The Committee for Medicinal Products for Human Use (CHMP), whose assessments guide the Commission's drug approval decisions, recommended Erbitux as an initial treatment of recurrent or metastatic squamous-cell cancer of the head and neck in combination with platinum-based chemotherapy.

A potential clearance would mark the second for the Erbitux injection in Europe to combat head and neck tumours as the drug is already cleared for use in combination with radiotherapy for locally advanced head and neck tumours since 2006.

Commission rulings normally follow within a couple of months of the initial endorsement of London-based CHMP.

Merck has said it expected the new use in head and neck cancer to raise the annual number of the drug's target patients by about 100,000 in Europe. It foresees as many as 570,000 patients per year in the region that could stand to benefit from Erbitux across all potential uses.

Erbitux was originally discovered by U.S. biotech company ImClone IMCL.O, which sold the marketing and development rights to the drug outside the United States and Canada to Merck.

ImClone's Erbitux partner in North America is Bristol-Myers Squibb (BMY.N).

Merck has said it expects full-year sales of Erbitux, based on the active ingredient cetuximab, to reach about 600 million euros in 2008 and to rise to blockbuster status in the next decade. (Reporting by Ludwig Burger; Editing by Victoria Main)



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