Alexion Pharmaceuticals has provided updates on the regulatory review and approval of Alexion’s Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of supply for Soliris (eculizumab).
The company reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a ‘positive opinion’ recommending final approval of the facility by the European Commission, which is expected in early 2010.
Separately, the company expects to meet with the FDA to provide additional available information, and to discuss their request for a limited number of production runs in connection with their pre-approval inspection process.
Stephen Squinto, executive vice president and head of research and development at Alexion, said: “We are pleased to receive the positive opinion from the CHMP, which would give us the option to use ARIMF as a second source to supply Soliris to European countries following final EU approval. We now look forward to progressing our discussions and satisfying the requirements of the FDA, which would give us the additional option of using our Rhode Island facility as a second source to serve the US market as well.”
Alexion also reported that regulatory authorities have now permitted release to the marketplace of all batches of Soliris that were filled by this external vialer. The previously described contingent liability associated with these batches has now been completely resolved at no loss to the company.
Since 2006, Alexion has been developing ARIMF to become a second source of supply of Soliris and to manufacture other antibody products. The facility does not yet provide Soliris for commercial use in any market. As a result of the company’s previously described multi-source strategy, Alexion has existing supplies of Soliris sufficient to serve all anticipated clinical and commercial needs, while continuing to source product from its primary provider.