Research to be Presented at the American Transplant Congress Examines the Role of Terminal Complement Inhibition in the Treatment of Kidney Transplantation Patients
Investigators To Report Additional Results from Clinical Trial of
Soliris(R) (eculizumab) for the Prevention of
Antibody-Mediated Rejection
CHESHIRE, Conn., Apr 30, 2010 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that
researchers are scheduled to present clinical and laboratory research on
the role of terminal complement inhibition therapy in kidney
transplantation patients at high risk for antibody-mediated rejection
(AMR) at the American Transplant Congress, being held May 1 to 5, 2010,
in San Diego. This research includes interim results from an
investigator-initiated study of Soliris(R) (eculizumab) for the
prevention of AMR in kidney transplantation patients.
Abstracts listed below can be accessed at: http://www.abstracts2view.com/atc/index.php.
Abstract #1 will be presented during a plenary session on Sun., May 2 at
8:30 a.m.:
-
"Terminal Complement Inhibition Decreases Early Acute Humoral
Rejection in Sensitized Renal Transplant Recipients," Dr. Mark D.
Stegall, et al.
Abstract #1510 will be presented during a poster session on Mon., May 3
from 5:30 - 6:30 p.m.:
-
"Renal Transplantation in a Patient with Catastrophic Antiphospholipid
Antibody Syndrome (CAPS)," Dr. Bonnie E. Lonze, et al.
Abstract #1509 will be presented during a poster session on Mon., May 3
from 5:30 - 6:30 p.m.:
-
"New Therapies and Nontraditional Modalities Can Be Combined To
Salvage Sensitized Patients with Exhausted Venous Access," Dr. Bonnie
E. Lonze, et al.
Abstract #288 will be presented during a concurrent session on Mon., May
3 at 5:00 p.m.
-
"Chronic Humoral Rejection Despite C5 Inhibition after
Positive-Crossmatch Kidney Transplantation (+XMKTx)," Dr. Lynn D.
Cornell, et al.
Abstract #LB15 will be presented during a poster session on Tues., May 4
from 5:30 - 6:30 p.m.:
-
"Complement Inhibitors for Treatment of Antibody-Mediated Renal
Allograft Injury," Dr. Bonnie E. Lonze, et al.
About Soliris
Soliris is not approved for the treatment of antibody-mediated rejection
(AMR) in kidney transplantation patients and is being provided to
patients in clinical studies on an investigational basis. Soliris is a
first-in-class terminal complement inhibitor developed from the
laboratory through regulatory approval by Alexion. Soliris has been
approved in the United States, European Union, Japan and other countries
as the first treatment for patients with paroxysmal nocturnal
hemoglobinuria (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 patients with 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 www.soliris.net.
Important Safety Information
Soliris is generally well tolerated in patients with PNH. The most
frequent adverse events observed in clinical studies of patients with
PNH were headache, nasopharyngitis (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 PNH 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, other
inflammatory disorders, and cancer. 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]
Safe Harbor Statement
This news release contains forward-looking statements, including
statements related to anticipated clinical development milestones and
potential health and medical benefits of Soliris (eculizumab) for the
potential treatment of patients with antibody mediated rejection (AMR)
of transplant organs. 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, delays in
arranging satisfactory manufacturing capability and establishing
commercial infrastructure, the possibility that results of published
reports or clinical trials are not predictive of safety and efficacy
results of Soliris in broader patient populations, the risk that
clinical trials may not be completed successfully, the possibility that
initial results of commercialization are not predictive of future rates
of adoption of Soliris, the risk that third parties won't agree to
license any necessary intellectual property to Alexion on reasonable
terms or at all, the risk that third party payors will not reimburse for
the use of Soliris at acceptable rates or at all, 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 Annual Report on Form 10-K for the period
ended December 31, 2009, 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.
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director Corporate Communications
or
Media:
Makovsky & Company
Mark Marmur, 212-508-9670
or
Investors:
Rx Communications
Rhonda Chiger, 917-322-2569
Copyright Business Wire 2010