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UPDATE 1-EU backs Gilead once-daily HIV pill, other drugs

Thu Oct 18, 2007 1:56pm EDT

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(Adds further details on products, Gilead shares)

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LONDON, Oct 18 (Reuters) - The European Medicines Agency said on Thursday it recommended approval of four new drugs -- including the first once-daily HIV tablet -- and two biosimilars, or copies of biotech medicines.

Shares in U.S. drugmaker Gilead Sciences (GILD.O) rose nearly 2 percent on Nasdaq following news of the positive opinion for its AIDS medicine Atripla, which is partnered with Bristol-Myers Squibb (BMY.N) and Merck & Co (MRK.N).

Also recommended for approval at the monthly meeting of the agency's main medicines committee were GlaxoSmithKline's (GSK.L) hayfever treatment Avamys, Abraxis BioScience's ABBI.O cancer drug Abraxane and pain drug Nevanac from Alcon (ACL.N).

The European watchdog also backed two biosimilar EPO anaemia products from generic drugmakers Stada (STAGn.DE) and Hospira (HSP.N), adding to its reputation as a pioneer in approving cheaper copy versions of costly biotech treatments.

The agency decided to turn down, however, an application from Actelion (ATLN.VX) for a new use of its established medicine Zavesca in treating Niemann-Pick type C disease, an inherited neurodegenerative disease of childhood and adolescence.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.



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