Researchers to Present Additional Data on Soliris® (eculizumab) for the Treatment of Patients With PNH at the ASH Annual Meeting
Physician Experience with Eculizumab in Patients with Atypical
Hemolytic Uremic Syndrome Also to be Presented
CHESHIRE, Conn., Nov 10, 2009 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that
researchers are scheduled to present data relating to Soliris(R)
(eculizumab) as a treatment for patients with paroxysmal nocturnal
hemoglobinuria (PNH) during the 51st Annual Meeting of the American
Society of Hematology (ASH), to be held December 5 - 8, 2009 at the
Ernst N. Morial Convention Center in New Orleans. Physicians are also
scheduled to report on their experience with eculizumab in patients with
atypical Hemolytic Uremic Syndrome (aHUS) during the meeting. Abstracts
summarizing these presentations were published today on the ASH web site
and can be accessed using the links provided below. Soliris is a
complement inhibitor approved for the treatment of PNH to reduce
hemolysis. Soliris is currently under investigation for the treatment of
aHUS.
The following abstract will be presented in a poster session on
Saturday, December 5, 2009 from 5:30 - 7:30 p.m., Central Standard Time
(CST):
"Chronic Renal Insufficiency in Japanese Patients with Paroxysmal
Nocturnal Hemoglobinuria (PNH): Improvement with Eculizumab Treatment in
the Long-Term Follow-up of the AEGIS Study," Kanakura, et al.
Abstract: http://ash.confex.com/ash/2009/webprogram/Paper16844.html.
The following abstracts will be presented in a poster session on Sunday,
December 6, 2009 from 6:00 - 8:00 p.m. CST:
"Successful Treatment of aHUS Recurrence and Arrest of Plasma Exchange
Resistant TMA Post-Renal Transplantation with the Terminal Complement
Inhibitor Eculizumab," Legault and Boelkins.
Abstract: http://ash.confex.com/ash/2009/webprogram/Paper16845.html.
"Effects of Eculizumab Therapy in Patients with Paroxysmal Nocturnal
Hemoglobinuria (PNH) Receiving Concurrent Immunosuppressive Therapy for
Bone Marrow Insufficiency," Schrezenmeier, et al. Poster II-979.
Abstract: http://ash.confex.com/ash/2009/webprogram/Paper16843.html.
"Identification and Clinical Significance of Type II Granulocytes Among
Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Identified Using
Multiparameter High-Sensitivity Flow Cytometry," Movalia, et al.
Abstract: http://ash.confex.com/ash/2009/webprogram/Paper24600.html.
The following abstracts will be presented in a poster session on Monday,
December 7, 2009 from 6:00 - 8:00 p.m. CST:
"Clinical Impact of Unregulated Terminal Complement Activity in
Never-Transfused Patients with Paroxysmal Nocturnal Hemoglobinuria,"
Muus, et al.
Abstract: http://ash.confex.com/ash/2009/webprogram/Paper18021.html.
"Terminal Complement Inhibitor Eculizumab Improves Complement-Mediated
Platelet Consumption and Thrombocytopenia in Patients with Paroxysmal
Nocturnal Hemoglobinuria (PNH)," Socie, et al.
Abstract: http://ash.confex.com/ash/2009/webprogram/Paper18023.html.
About Soliris
Soliris has been approved by the U.S. Food and Drug Administration
(March 2007), the European Commission (June 2007), Health Canada
(January 2009) and Australia's Therapeutic Goods Administration
(February 2009) as the first treatment for all patients with PNH, an
ultra-rare, debilitating and life-threatening blood disorder defined by
chronic hemolysis, or the destruction of red blood cells. Prior to these
approvals, there were no therapies specifically available for the
treatment of PNH. More information on Soliris is available at www.soliris.net.
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 drug therapies 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, cancer, and
autoimmune disorders. Soliris is Alexion's first marketed product.
Alexion is evaluating other potential indications for Soliris as well as
other formulations of eculizumab for additional clinical indications,
and is pursuing development of other antibody product candidates in
early stages of development. This press release and further information
about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
[ALXN-G]
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director Corporate Communications
or
Makovsky & Company
Media:
Kristie Kuhl, 212-508-9642
or
Rx Communications
Investors:
Rhonda Chiger, 917-322-2569
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