Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that
the United States Patent and Trademark Office (USPTO) has issued
U.S. Patents No. 9,732,149; 9,718,880; and 9,725,504, which are
directed to the composition of matter of eculizumab (Soliris®),
pharmaceutical formulations of eculizumab, and methods of treating
paroxysmal nocturnal hemoglobinuria (PNH) with eculizumab,
respectively, and which will expire in 2027.
“Alexion is the leader in complement biology and has invested
decades of ground-breaking research and development in Soliris. We
continue to strengthen our patent portfolio around this unique
complement inhibitor,” said Ludwig Hantson, Chief Executive Officer
of Alexion. “These new patents work in concert with other patents
and regulatory exclusivities to protect Soliris in all
indications.”
The new composition of matter patent is directed to the
full-length amino acid sequence of eculizumab and covers molecules
that contain the same sequence. The new formulation patent is
directed to pharmaceutical compositions that contain eculizumab,
independent of their intended use. The new method of use patent is
directed to treating PNH with eculizumab, and supplements other
patents that are directed to treating atypical hemolytic uremic
syndrome (aHUS) and other complement-mediated diseases with
eculizumab.
Alexion is pursuing corresponding patent applications in other
regions and countries, including Europe and Japan. In addition,
Alexion is pursuing patent applications for pending additional
indications of Soliris, such as for the treatment of refractory
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) and atypical hemolytic uremic
syndrome (aHUS).
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
addition, Alexion has submitted applications in the U.S., EU and
Japan for Soliris as a potential treatment of refractory gMG in
patients who are anti-acetylcholine receptor (AChR)
antibody-positive. In June 2017, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) adopted a positive opinion for this new indication. Soliris
is not indicated for the treatment of patients with Shiga-toxin E.
coli-related hemolytic uremic syndrome (STEC-HUS). 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.
About Alexion
Alexion is a global biopharmaceutical company focused on
developing and delivering life-transforming therapies for patients
with devastating and rare disorders. 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) and atypical hemolytic
uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
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, the risks and uncertainties of drug
development, decisions of regulatory authorities regarding the
adequacy of our research, marketing approval or material
limitations on the marketing of eculizumab, 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 clinical trials of our product candidates
could be delayed, the adequacy of our pharmacovigilance and drug
safety reporting processes, the risk that third party payers
(including governmental agencies) will not reimburse or continue to
reimburse for the use of our products at acceptable rates or at
all, the outcome of challenges and opposition proceedings to our
intellectual property, assertion or potential assertion by third
parties that the manufacture, use or sale of our products infringes
their intellectual property, risks regarding government
investigations, including investigations of Alexion by the SEC and
DOJ, the risk that anticipated regulatory filings are delayed, the
risk that estimates regarding the number of patients with the
diseases our products treat are inaccurate, and a variety of other
risks set forth from time to time in Alexion's filings with the
U.S. 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, 2017 and in our other filings with
the U.S. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170815006031/en/
Alexion Pharmaceuticals, Inc.MediaArne Naeveke, PhD,
475-230-3774Executive Director, Product
CommunicationsorInvestorsElena Ridloff, CFA, 475-230-3601Vice
President, Investor RelationsorCatherine Hu, 475-230-3599Director,
Investor Relations
Alexion Pharmaceuticals (NASDAQ:ALXN)
Historical Stock Chart
From Apr 2024 to May 2024
Alexion Pharmaceuticals (NASDAQ:ALXN)
Historical Stock Chart
From May 2023 to May 2024