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New Clinical Trial Data Show Substantial Improvement With Eculizumab (Soliris®) In Patients With STEC-HUS

Stocks in this article: ALXN

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. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.

[ALXN-G]

Safe Harbor Statement

This news release contains forward-looking statements, including statements related to anticipated clinical development, regulatory and commercial milestones and potential health and medical benefits of Soliris ® (eculizumab) for the potential treatment of patients with STEC-HUS. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Soliris for its current or potential new indications, and a variety of other risks set forth from time to time in Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended September 30, 2012, and in Alexion's other filings with the Securities and Exchange Commission. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

References

1.  

Stahl RA, on behalf of the STEC-HUS Study Group. Open-label, multi-center trial of eculizumab in patients with Shiga-toxin-producing E. coli hemolytic uremic syndrome (STEC-HUS). Presented at the American Society of Nephrology Kidney Week 2012, San Diego, Calif., November 3, 2012. Abstract SA-OR102.

2.

Stahl RA. Multi-center clinical study of eculizumab for Shiga-toxin-producing E. coli hemolytic uremic syndrome (STEC-HUS). Presented at the 44th Meeting of the American Society of Nephrology, Philadelphia, Pa., November 8–13, 2011.

3.

Orth D, Khan AB, Naim A, et al. Shiga toxin activates complement and binds factor H: evidence for an active role of complement in hemolytic uremic syndrome. J Immunol. 2009;182:6394-6400.

4.

Morigi M, Galbusera M, Gastoldi S, et al. Alternative pathway activation of complement by Shiga toxin promotes exuberant C3a formation that triggers microvascular thrombosis. J Immunol. 2011;187:172-80.

5.

Jacob A, Hensley LK, Safratowich BD, Quigg RJ, Alexander JJ. The role of the complement cascade in endotoxin-induced septic encephalopathy. Lab Invest. 2007;87(12):1186-94.

6.

Johnson S, Waters A. Is complement a culprit in infection-induced forms of haemolytic uraemic syndrome? Immunology. 2012;217(2):235-43.

7.

Palermo MS, Exeni RA, Fernandez GC. Hemolytic uremic syndrome: pathogenesis and update of interventions. Expert Rev Anti Infect Ther. 2009;7(6):697-707.

8.

Gallo EG, Gianantonio CA. Extrarenal involvement in diarrhea-associated haemolytic uraemic syndrome. Pediatr Nephrol. 1995;9(1):117-9.

9.

Noris M, Mescia F, Remuzzi G. STEC-HUS, atypical HUS and TTP are all diseases of complement activation. Nat Rev Nephrol. 2012;8(11):622-33.

10.

Tarr PI, Gordon CA, Chandler WL. Shiga-toxin-producing Escherichia coli and haemolytic uraemic syndrome. Lancet. 2005;365:1073-86.

11.

Bell BP, Griffin PM, Lozano P, Christie DL, Kobayashi JM, Tarr PI. Predictors of hemolytic uremic syndrome in children during a large outbreak of Escherichia coli O157:H7 infections. Pediatrics. 1997;100(1):E12.

12.

Oakes RS, Siegler RL, McReynolds MA, Pysher T, Pavia AT. Predictors of fatality in postdiarrheal hemolytic uremic syndrome. Pediatrics. 2006;117:1656-62.

13.

Garg AX, Suri RS, Barrowman N, et al. Long-term renal prognosis of diarrhea-associated hemolytic uremic syndrome: a systematic review, meta-analysis, and meta-regression. JAMA. 2003;290:1360-70.

14.

Rosales A, Hofer J, Zimmerhackl LB, et al. Need for long-term follow-up in enterohemorrhagic Escherichia coli-associated hemolytic uremic syndrome due to late-emerging sequelae. Clin Infect Dis. 2012;54(10):1413-21.

15.

Loirat C, Noris M, Fremaux-Bacchi V. Complement and the atypical hemolytic uremia syndrome in children. Pediatr Nephrol. 2008;23:1957-72.

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Benz K, Amann K. Thrombotic microangiopathy: new insights. Curr Opin Nephrol Hypertens. 2010;19:242-7.

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Zipfel PF, Heinen S, Skerka C. Thrombotic microangiopathies: new insights and new challenges. Curr Opin Nephrol Hypertens. 2010;19(4):372-8.





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