The U.S. Food and Drug Administration has approved Alexion Pharmaceuticals Inc.’s Smithfield, R.I.-based manufacturing facility as a second source of commercial supply its drug Soliris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH).
The Rhode Island site already has approval from the European Medicines Agency as a second source of Soliris supply in the European Union. The U.S. and the E.U. account for 90 percent of Alexion’s 2009 revenue, the company reported. Further applications for regulatory approval of the Rhode Island manufacturing site are in the works with other countries where Alexion is planning to commercialize Soliris.
PNH is a rare blood disorder that is potentially fatal. Currently, Soliris is the only drug approved specifically to treat PNH, Alexion officials noted in a press release, and it’s also being tested as a treatment for other rare disorders associated with nephrology and transplants.
Cheshire, Conn.-based Alexion Pharmaceuticals reported in July that its revenue and profits rose in the second quarter of the year, buoyed by the climb in revenue from Soliris.
In January, 2009, Alexion resolved an ongoing patent dispute with PDL BioPharma Inc. over Soliris. It paid $25 million to PDL BioPharma for rights to use some of PDL’s patent portfolio called the Queen in Soliris.