NEW HAVEN, Conn.--(BUSINESS WIRE)--
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
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
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
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.
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.
Arne Naeveke, PhD,
Executive Director, Product Communications
Ridloff, CFA, 475-230-3601
Vice President, Investor Relations
Director, Investor Relations
Source: Alexion Pharmaceuticals, Inc.
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