NEW HAVEN, Conn.--(BUSINESS WIRE)--
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced today that the
Japanese Patent Office (JPO) has issued patent No. 6224059, directed to
the composition of matter of eculizumab (Soliris®) and
pharmaceutical formulations of eculizumab, which will expire in 2027.
"Alexion is pleased that the JPO has granted an additional patent for
Soliris, enhancing our global portfolio of intellectual property
protection for this novel complement inhibitor," said Ludwig Hantson,
Chief Executive Officer of Alexion. "As we continue to serve patients in
Japan and invest in additional research and development for Soliris, we
look forward to working with other jurisdictions around the world to
further strengthen our patent portfolio."
As previously announced, the United States Patent and Trademark Office
(USPTO) issued three U.S. patents earlier this year directed to the
composition of matter of eculizumab, pharmaceutical formulations of
eculizumab, and methods of treating paroxysmal nocturnal hemoglobinuria
(PNH) with eculizumab. These patents will expire in 2027.
Alexion is pursuing corresponding patent applications for eculizumab in
other regions and countries, including Europe. In addition, Alexion is
pursuing patent applications for additional indications of Soliris,
including for the treatment of anti-acetylcholine receptor (AchR)
antibody-positive generalized myasthenia gravis (gMG).
About Soliris® (eculizumab)
Soliris® is a first-in-class complement inhibitor that works
by inhibiting the terminal part of the complement cascade, a part of the
immune system that, when activated in an uncontrolled manner, plays a
role in serious ultra-rare disorders like paroxysmal nocturnal
hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and
anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis
(MG). Soliris is approved in the U.S., EU, Japan and other countries as
the first and only treatment for patients with PNH and aHUS, in the EU
as the first and only treatment of refractory gMG in adults who are
anti-AchR antibody-positive, and in the U.S. for the treatment of adult
patients with gMG who are anti-AchR antibody-positive. Alexion's new
drug application in Japan for Soliris as a treatment for patients with
anti-AchR antibody-positive refractory gMG has been accepted for review
by the Japanese Ministry of Health, Labour and Welfare (MHLW). Soliris
is not indicated for the treatment of patients with Shiga-toxin E.
coli-related hemolytic uremic syndrome (STEC-HUS).
Soliris has received Orphan Drug Designation (ODD) for the treatment of
patients with PNH in the U.S., EU, Japan and many other countries, for
the treatment of patients with aHUS in the U.S., EU and many other
countries, for the treatment of patients with MG in the U.S. and EU, and
for the treatment of patients with refractory gMG in Japan. Alexion and
Soliris have received some of the pharmaceutical industry's highest
honors for the medical innovation in complement inhibition: the Prix
Galien USA (2008, Best Biotechnology Product) and France (2009, Rare
Disease Treatment).
For more information on Soliris, please see full prescribing information
for Soliris, including BOXED WARNING regarding risk of serious
meningococcal infection, available at www.soliris.net.
Important Soliris Safety Information
The U.S. prescribing information for Soliris includes the following
warnings and precautions: Life-threatening and fatal meningococcal
infections have occurred in patients treated with Soliris. Meningococcal
infection may become rapidly life-threatening or fatal if not recognized
and treated early. Comply with the most current Centers for Disease
Control (CDC)'s Advisory Committee on Immunization Practices (ACIP)
recommendations for meningococcal vaccination in patients with
complement deficiencies. Immunize patients with meningococcal vaccines
at least two weeks prior to administering the first dose of Soliris,
unless the risks of delaying Soliris therapy outweigh the risk of
developing a meningococcal infection. Monitor patients for early signs
of meningococcal infections and evaluate immediately if infection is
suspected. Soliris is available only through a restricted program under
a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris
REMS, prescribers must enroll in the program. Enrollment in the Soliris
REMS program and additional information are available by telephone:
1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.
Patients may have increased susceptibility to infections, especially
with encapsulated bacteria. Aspergillus infections have occurred in
immunocompromised and neutropenic patients. Children treated with
Soliris may be at increased risk of developing serious infections due to Streptococcus
pneumoniae and Haemophilus influenza type b (Hib). Soliris
treatment of patients with PNH should not alter anticoagulant management
because the effect of withdrawal of anticoagulant therapy during Soliris
treatment has not been established. Administration of Soliris may result
in infusion reactions, including anaphylaxis or other hypersensitivity
reactions.
In patients with PNH, the most frequently reported adverse events
observed with Soliris treatment in clinical studies were headache,
nasopharyngitis, back pain and nausea. In patients with aHUS, the most
frequently reported adverse events observed with Soliris treatment in
clinical studies were headache, diarrhea, hypertension, upper
respiratory infection, abdominal pain, vomiting, nasopharyngitis,
anemia, cough, peripheral edema, nausea, urinary tract infections, and
pyrexia. In patients with gMG who are anti-AchR antibody-positive, the
most frequently reported adverse reaction observed with Soliris
treatment in the placebo-controlled clinical study (≥10%) was
musculoskeletal pain.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases through the innovation,
development and commercialization of life-changing therapies. Alexion is
the global leader in complement inhibition and has developed and
commercializes the first and only approved complement inhibitor to treat
patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical
hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR)
antibody-positive generalized myasthenia gravis (gMG). In addition,
Alexion has two highly innovative enzyme replacement therapies for
patients with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). As
the leader in complement biology for over 20 years, Alexion focuses its
research efforts on novel molecules and targets in the complement
cascade, and its development efforts on the core therapeutic areas of
hematology, nephrology, neurology, and metabolic disorders. This press
release and further information about Alexion can be found at: www.alexion.com.
[ALXN-G]
Forward-Looking Statement
This news release contains forward-looking statements, including
statements related to Soliris intellectual property, and the strength
and scope of Soliris intellectual property protection. 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 the adequacy of our research, marketing
approval or material limitations on the marketing of our products,
delays, interruptions or failures in the manufacture and supply of our
products and our product candidates, failure to satisfactorily address
matters raised by the FDA and other regulatory agencies, the possibility
that results of clinical trials are not predictive of safety and
efficacy results of our products in broader patient populations, the
possibility that current rates of adoption of Soliris in PNH, aHUS or
other diseases are not sustained, the possibility that clinical trials
of our product candidates could be delayed, the adequacy of our
pharmacovigilance and drug safety reporting processes, the risk that
third party payors (including governmental agencies) will not reimburse
or continue to reimburse for the use of our products at acceptable rates
or at all, uncertainties surrounding legal proceedings, company
investigations and government investigations, including investigations
of Alexion by the U.S. Securities and Exchange Commission (SEC) and U.S.
Department of Justice, the risk that anticipated regulatory filings are
delayed, the risk that estimates regarding the number of patients with
PNH, aHUS, gMG, HPP and LAL-D are inaccurate, the risks of changing
foreign exchange rates, risks relating to the potential effects of the
Company's restructuring and relocation of its corporate headquarters,
and a variety of other risks set forth from time to time in Alexion's
filings with the SEC, including but not limited to the risks discussed
in Alexion's Quarterly Report on Form 10-Q for the period ended
September 30, 2017 and in our other filings with the SEC. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171106005129/en/
Alexion Pharmaceuticals, Inc.
Media
Kim Diamond, 475-230-3775
Executive
Director, Corporate Communications
or
Investors
Elena
Ridloff, CFA, 475-230-3601
Vice President, Investor Relations
or
Catherine
Hu, 475-230-3599
Director, Investor Relations
Source: Alexion Pharmaceuticals, Inc.
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