UPDATE 1-Alexion manufacturing unit gets positive CHMP opinion

Wed Dec 2, 2009 7:38am EST

* Sees Rhode Island unit approval in early 2010

* To discuss limited production runs with FDA

Dec 2 (Reuters) - Alexion Pharmaceuticals Inc (ALXN.O) said an advisory committee of European health regulators has recommended final approval of the biopharmaceutical company's Rhode Island manufacturing facility by the European Commission.

Alexion said the Committee for Medicinal Products for Human Use (CHMP) gave a "positive opinion" to approve the facility as a second source to develop the company's drug Soliris, which is expected in early 2010.

Soliris is a drug to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare genetic disorder that can lead to anemia, fatigue, pain and difficulty in breathing.

Alexion's Smithfield, Rhode Island facility does not yet provide Soliris for commercial use in any market, the company said.

Also, Alexion expects to meet with the U.S. Food and Drug Administration to provide additional information and to discuss their request for a limited number of production runs in connection with their pre-approval inspection process.

Shares of the company closed at $46.10 Tuesday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Kavita Chandran) ((anuradha.ramanathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800: Reuters Messaging: anuradha.ramanathan.reuters.com@reuters.net))

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