Alexion Receives FDA Approval of Rhode Island Manufacturing Facility for Soliris® Supply
-- Follows Earlier EMA Approval for Facility --
-- Provides Second Source for Commercial and Clinical Needs --
CHESHIRE, Conn., Aug 23, 2010 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the US
Food and Drug Administration (FDA) has approved Alexion's Rhode Island
manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second
source of commercial supply for Soliris(R) (eculizumab). Earlier this
year, Alexion reported that the European Medicines Agency had approved
ARIMF as a second source of supply for Soliris in the European Union
(EU). In addition to sourcing Soliris from ARIMF, the Company will
maintain its agreement with its long-time contract manufacturer; either
source can now meet all of the Company's forecasted commercial and
clinical needs for Soliris in the US and EU, which territories accounted
for more than 90% of the Company's 2009 revenues. Additionally, Alexion
has applied for regulatory approvals for ARIMF in other countries where
it has, or is establishing, commercial operations.
Soliris is the only drug specifically indicated for the treatment of
patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare,
debilitating and life-threatening blood disorder. Soliris was approved
by the FDA and the European Commission in 2007, as well as by the
regulatory authorities of other countries, including Japan's Ministry of
Health, Labour and Welfare (MHLW) in 2010. In addition, more than a
dozen clinical studies of Soliris as a treatment for patients with other
severe and ultra-rare disorders are currently underway in areas that
include nephrology and transplant. Among these are clinical studies with
Soliris treatment of two cohorts of patients with atypical hemolytic
uremic syndrome (aHUS) as well as transplant patients at elevated risk
of antibody-mediated graft rejection.
"Since before the launch of Soliris in 2007, we recognized the critical
importance of ensuring the continuity of treatment for patients with
ultra-rare and life-threatening diseases," said Stephen P. Squinto,
Executive Vice President and Head of Research and Development at
Alexion. "Uninterrupted world-wide supply of Soliris provides patients
with continued access to stable treatment regimens, and also supports
our growing clinical development programs."
About Soliris
Soliris (eculizumab) is a first-in-class terminal complement inhibitor
developed from the laboratory through regulatory approval by Alexion.
Soliris has been approved by the healthcare authorities in the U.S.,
European Union, Japan and other countries as the first treatment for
patients with PNH, an ultra-rare, debilitating and life-threatening
blood disorder defined by hemolysis, or the destruction of red blood
cells. Prior to these approvals, there was no therapy specifically
available for the treatment of PNH.
Patients with PNH in more than 20 countries now have access to Soliris
therapy through national or private healthcare providers. As the first
terminal complement inhibitor to be approved in countries around the
world, Soliris represents a long-sought breakthrough in medical
innovation. 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]
This news release contains forward-looking statements, including
statements related to regulatory approvals of Alexion's Rhode Island
Manufacturing Facility in different territories, and supplies of Soliris
for commercial and clinical purposes.. 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 global
regulatory authorities regarding ARIMF as an approved manufacturing
facility for Soliris or other products and Alexion's continued ability
to operate ARIMF in a compliant manner, regulatory compliance and
production capabilities of third party suppliers, the accuracy of
inventory forecasts, market conditions, 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 June 30,
2010 and in our 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
Kristie Kuhl, 212-508-9642
or
Investors:
Rx Communications
Rhonda Chiger, 917-322-2569
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