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Last $141.11 USD
Change Today +5.75 / 4.25%
Volume 1.6M
As of 8:10 PM 02/12/16 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

352 Knotter Drive

Cheshire, CT 06410

United States

Phone: 203-272-2596

Fax: 203-271-8198

Alexion Pharmaceuticals, Inc., a biopharmaceutical company, focuses on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products. The company’s marketed product, Soliris, is the first therapeutic approved for patients with either of two severe and ultra-rare disorders resulting from chronic uncontrolled activation of the complement component of the immune system, such as paroxysmal nocturnal hemoglobinuria (PNH), a life-threatening and ultra-rare genetic blood disorder, and atypical hemolytic uremic syndrome (aHUS), a life-threatening and ultra-rare genetic disease. The company is also evaluating additional potential indications for Soliris in severe and devastating diseases in which uncontrolled complement activation is the underlying mechanism, and it is progressing in various stages of development with additional biotechnology product candidates as treatments for patients with severe and life-threatening ultra-rare disorders. Products and Development Programs The company focuses its product development programs on life-transforming therapeutics for severe and life-threatening ultra-rare diseases for which current treatments are either non-existent or inadequate. Eculizumab is a humanized antibody known as a C5 terminal complement inhibitor (C5 Inhibitor), which is designed to selectively block the cleavage of C5 and hence the production of the pro-inflammatory, pro-thrombotic and cytolytic proteins of the terminal complement cascade. In addition to PNH and aHUS, for which the use of eculizumab has been approved in the United States, Europe, Japan, and other countries, C5 Inhibitors might be useful in the treatment of various other serious diseases and conditions resulting from uncontrolled complement activation. Marketed Products PNH Soliris is the first therapy approved for the treatment of patients with PNH, a debilitating and life-threatening ultra-rare blood disorder in which an acquired genetic deficiency causes uncontrolled complement activation, which leads to life-threatening complications. The company continues to work with researchers to expand the base of knowledge in PNH and the utility of Soliris to treat patients with PNH. Soliris was approved for the treatment of PNH by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in 2007 and by Japan’s Ministry of Health, Labour and Welfare (MHLW) in 2010; and has been approved in various other territories. Additionally, Soliris has been granted orphan drug designation for the treatment of PNH in the United States, Europe, Japan, and various other territories. In 2013, the EC extended the Soliris label to include pediatric patients with PNH. Additionally, the company is sponsoring a multinational registry to gather information regarding the natural history of patients with PNH and the longer term outcomes during Soliris treatment. aHUS aHUS is a chronic and life-threatening ultra-rare genetic disease in which uncontrolled complement activation causes blood clots in small blood vessels throughout the body, or TMA (thrombotic microangiopathy), leading to kidney failure, stroke, heart attack, and death. Soliris is the first therapy approved for the treatment of pediatric and adult patients with aHUS. Pursuant to a post marketing requirement imposed by the FDA, the company has completed enrollment in a prospective open-label trial in adults with aHUS, and separately, enrollment has been completed in a prospective trial of pediatric patients with aHUS. In May 2014, based on data from these trials, the FDA approved conversion of Soliris accelerated approval in aHUS to regular approval for the treatment of adult and pediatric patients with aHUS to inhibit complement-mediated TMA. Clinical Development Program Soliris (eculizumab) Transplant Delayed Kidney Transplant Graft Function: Delayed graft function (DGF) is the term used to describe the failure of a kidney or other organs to function immediately after transplantation due to ischemia-reperfusion and immunological injury. Enrollment has been complete


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