Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that researchers are scheduled to present data from clinical studies of Soliris ® (eculizumab) in patients with atypical hemolytic uremic syndrome (aHUS) and Shiga toxin-producing E. Coli hemolytic uremic syndrome (STEC-HUS), two severe and life-threatening ultra-rare disorders caused by uncontrolled complement activation, at the annual meeting of the American Society of Nephrology (ASN). Abstracts summarizing these presentations were published today on the ASN website and can be accessed using the links below. The ASN annual meeting will be held October 30 – November 4, 2012 in San Diego, California. Soliris is approved in the US, European Union, Japan and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is also approved in the United States as the first and only treatment for patients with atypical hemolytic uremic syndrome (aHUS), a debilitating, ultra-rare, life-threatening and chronic genetic disorder characterized by complement-mediated thrombotic microangiopathy (blood clots in small vessels). Soliris is not indicated for the treatment of patients with Shiga toxin-producing E. Coli hemolytic uremic syndrome (STEC-HUS). Soliris and aHUS The following abstract will be presented in a poster presentation on Thursday, November 1, 2012 from 10:00 a.m. – 12:00 p.m., Pacific Daylight Time (PDT): Abstract TH-PO442: “Eculizumab Is Effective in Patients with Atypical Hemolytic Uremic Syndrome (aHUS) Regardless of Underlying Genetic Mutations or Complement Factor H (CFH) Auto-Antibodies,” Goodship, et al. Accessible at: http://www.abstracts2view.com/asn_2012/view.php?nu=5648&terms=&type=abstract The following abstract will be presented in a poster session on Saturday, November 3, 2012 from 10:00 a.m. – 12:00 p.m., PDT: Abstract SA-PO1039: “Eculizumab Therapy in an Atypical Hemolytic Uremic Syndrome (aHUS) Patient with Long-Term Renal Failure and Posterior Reversible Encephalopathy Syndrome (PRES),” Povey, et al.
In patients with PNH, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of patients with PNH should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were hypertension, upper respiratory tract infection, diarrhea, headache, anemia, vomiting, nausea, urinary tract infection, and leukopenia. Please see full prescribing information for Soliris, including boxed WARNING regarding risk of serious meningococcal infection.About Alexion Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris ® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 40 countries for the treatment of PNH, and in the United States and the European Union for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is developing four other highly innovative biotechnology product candidates, which are being investigated across eight severe and ultra-rare disorders beyond PNH and aHUS. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com. [ALXN-G]