Press Releases
November 8, 2010 at 12:50 PM EST

Researchers to Present New Long-Term Data on Soliris® (eculizumab) in Patients with PNH at the ASH Annual Meeting

CHESHIRE, Conn.--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that researchers are scheduled to present new data relating to Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 52nd Annual Meeting of the American Society of Hematology (ASH), to be held December 4 — 7, 2010 at the Orange County Convention Center in Orlando. New data regarding Alexion's anti-CD200 antibody samalizumab will also be presented at the ASH meeting. Abstracts summarizing these presentations were published today on the ASH web site and can be accessed using the links provided below.

Soliris and PNH

The following abstract will be presented in an oral session on Monday, December 6, 2010 at 3:15 p.m. EST:

"Long Term Treatment with Eculizumab In Paroxysmal Nocturnal Hemoglobinuria (PNH): Sustained Efficacy and Improved Survival," Kelly, et al.


The following abstract will be presented in a poster session on Saturday, December 4, 2010 from 5:30 — 7:30 p.m., Eastern Standard Time (EST):

"Evaluation of Paroxysmal Nocturnal Hemoglobinuria Disease Burden: The Patient's Perspective. A Report from the International PNH Registry," Muus, et al.


The following abstract will be presented in a poster session on Sunday, December 5, 2010 from 6:00 — 8:00 p.m. EST:

"Use of Blood Transfusions in Paroxysmal Nocturnal Hemoglobinuria Patients with and without Aplastic Anemia Enrolled in the Global PNH Registry," Schrezenmeier, et al.


The following abstracts will be presented in a poster session on Monday, December 6, 2010 from 6:00 — 8:00 p.m. EST:

"Long Term Safety and Efficacy of Sustained Eculizumab Treatment In Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)," Brodsky, et al.


"Association Between Elevated Hemolysis at Diagnosis and Early Mortality and Risk of Thrombosis In Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients with Cytopenia," Kim, et al.



During the meeting, researchers are also scheduled to present results from a Phase 1 study investigating samalizumab, an anti-CD200 antibody developed by Alexion, in patients with treatment refractory chronic lymphocytic leukemia or multiple myeloma.

The following abstract will be presented in a poster session on Sunday, December 5, 2010 from 6:00 — 8:00 p.m. EST:

"First-in-Human Phase I Dose Escalation Study of a Humanized Anti-CD200 Antibody (Samalizumab) in Patients with Advanced Stage B cell Chronic Lymphocytic Leukemia (B-CLL) or Multiple Myeloma (MM)," Mahadevan, et al.


About Soliris

Soliris is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris has been approved in the U.S., European Union, Japan and other territories as the first treatment for patients with PNH, an ultra-rare, debilitating and life-threatening blood disorder defined by uncontrolled complement activation which causes chronic hemolysis, or the destruction of red blood cells. Prior to these approvals, there were no therapies specifically available for the treatment of patients with PNH. Eculizumab (Soliris) is not approved for the treatment of aHUS, transplant or other indications other than PNH. Alexion's innovative approach to complement inhibition has received some of the pharmaceutical industry's highest honors: the 2008 Prix Galien USA Award for Best Biotechnology Product with broad implications for future biomedical research and the 2009 Prix Galien France Award in the category of Drugs for Rare Diseases. More information on Soliris is available at

Important Safety Information

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established.

The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection. Prior to beginning Soliris therapy, all patients and their prescribing physicians are encouraged to enroll in the PNH Registry, which is part of a special risk-management program that involves initial and continuing education and long-term monitoring for detection of new safety findings.

About Alexion

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing treatments for patients with serious and life-threatening medical conditions. Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, other inflammatory disorders, and cancer. Soliris is Alexion's first marketed product, and the Company is pursuing potential new indications for Soliris beyond PNH, as well as early-stage development of other antibody product candidates. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at



Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director Corporate Communications
Makovsky & Company
Kristie Kuhl, 212-508-9642
Rx Communications
Rhonda Chiger, 917-322-2569

Source: Alexion Pharmaceuticals, Inc.



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