Alexion Pharmaceutical’s (ALXN) Rhode Island manufacturing facility (ARIMF) should be up and running shortly as a second source of supply for the drug Soliris (eculizumab). The company recently received good news with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issuing a positive opinion related to the final approval of the facility by the European Commission, which is expected in early 2010.

Soliris, Alexion’s only US Food and Drug Administration (FDA) approved (approval received in March 2007) product, is a humanized monoclonal antibody complement inhibitor used for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare genetic blood disorder.

Alexion also announced its intention to seek FDA approval for this facility. The company will meet with the FDA to provide additional information, and to discuss its request for test production runs.

The Rhode Island facility does not yet provide Soliris for commercial use in any market. For the past few years, Alexion has been developing this facility as a second source of supply of Soliris as well as other antibody products.

Along with the US , Soliris is approved in the European Union, Canada , Latin America and Australia . With the intention of entering the Japanese market, Alexion submitted a New Drug Application (NDA) to the Pharmaceutical and Medical Devices Agency (PMDA), the Japanese regulatory authority, in April 2009 for Soliris. The company expects to launch Soliris in Japan in 2010.

We believe Soliris has strong growth potential – increased penetration in existing markets and contributions from new territories should help drive product sales. Although Soliris’ performance has been encouraging so far, we remain concerned about the company’s dependence on a single product for growth. Given the absence of any late-stage pipeline candidates, we are concerned about the company’s long term growth prospects. Given the circumstances, we are Neutral on the stock.

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