Alexion submits Soliris marketing applications to FDA, EMA for aHUS treatment

Alexion Pharmaceuticals, Inc.Apr 7 2011

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that the company has submitted marketing applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Soliris^® (eculizumab) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS).

Both the US and EU filings include the positive data from the two 26-week Phase 2 studies of Soliris as a treatment for adult and adolescent patients with aHUS. Preliminary data from these two studies were presented at the American Society of Nephrology (ASN) annual meeting in November 2010. Primary endpoints in both studies were achieved with statistical significance. aHUS is an ultra-rare, chronic and life-threatening disease in which uncontrolled complement activation causes blood clots in small blood vessels throughout the body (thrombotic microangiopathy, or TMA) leading to kidney failure, stroke, heart attack and death.

"The US and EU regulatory submissions put us one step closer toward accomplishing our goal to transform the lives of patients suffering with aHUS," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "We recognize that patients with aHUS, a life-threatening and ultra-rare disorder, lack adequate treatment options, and we look forward to working with regulatory authorities as they review our applications."

Updated 2011 Revenue Guidance

Alexion is updating its 2011 revenue guidance, from the previously announced range of $715- $735 million, now to the higher range of $720 to $740 million. Other items of previously announced 2011 guidance are being reiterated at this time.

The upward revision in revenue guidance takes into account continued global growth of Soliris for PNH, and the potential for an earlier than previously expected US launch of Soliris for aHUS. The earlier launch could occur if the US regulatory submission is accepted for priority review by the FDA and if a positive decision is then received, making a launch possible late in the fourth quarter of 2011. Further, the upward revision takes into account the potential for disruptions in treatment for individual patients in Japan associated with the recent natural disasters in that country.