Updated March 23 at 9:23am

Alexion gets FDA approval for Soliris


SMITHFIELD – Alexion Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration to manufacture the drug Soliris at its Smithfield facility, the company announced last week.

The Smithfield facility will serve as a second supply source for Soliris, which is already manufactured under contract by Swiss chemical and biotechnology company Lonza Group. Alexion said it will continue to maintain its long-term agreement with the supplier.

“Since before the launch of Soliris in 2007, we recognized the critical importance of ensuring the continuity for patients with ultra-rare and life-threatening diseases,” said Stephen P. Squinto, executive vice president and head of research and development for Alexion. “Uninterrupted worldwide supply of Soliris provides patients with continued access to stable treatment regimens.”

Alexion’s Smithfield location gained approval from the European Union’s European Medicines Agency in February. The company is seeking additional approval for the Smithfield plant from other countries where it has commercial operations.

In July, Alexion reported year-over-year improvements in its second quarter financial results due to increased sales of Soliris. For the three months ended June 30, Alexion posted a profit of $21.8 million, or 24 cents per diluted share, compared with a profit of $16.8 million, or 19 cents per diluted share, a year earlier. Revenue rose 36.4 percent to $125.8 million.

Operating expenses grew to $79.8 million from $61 million a year ago, led by increases in selling, general and administrative expenses.

“Our achievements in the second quarter reflect clinical benefits provided by the innovative complement-blockade technology of Soliris, and the continued strengthening of our growing global operations,” said Alexion CEO Leonard Bell.

Soliris (eculizumab) is the Cheshire, Conn.-based company’s only product on the market. It has been approved by the U.S., European Union and other countries as a treatment for paroxysmal nocturnal hemoglobinuria, or PNH, a rare blood disorder that destroys red blood cells and causes anemia.

The biopharmaceutical company is currently conducting clinical trials to explore additional uses for Soliris, including the treatment of atypical Hemolytic Uremic Syndrome (aHUS), a rare genetic disorder that causes sudden clinical deterioration.

“We look forward to the opportunity to serve more patients with PNH in the coming quarters, while progressing our aHUS and transplant programs to serve patients with other sever and ultra-rare disorders in the years ahead,” Bell added.

Additional information is available at www.alxn.com.


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