TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ --
Upholds decision by U.S. District Court to invalidate Amgen's
patent claims directed to PCSK9 antibodies
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the United States Court of
Appeals for the Federal Circuit upheld the decision by the U.S.
District Court for the District of Delaware that Amgen's asserted patent claims
directed toward PCSK9 (proprotein convertase subtilisin/kexin type
9) antibodies are invalid based on lack of enablement. The Federal
Circuit ruling means that Regeneron and Sanofi have successfully
invalidated all five of Amgen's asserted claims relevant to
Praluent® (alirocumab).
"We are pleased with today's decision by the Federal Circuit,
which affirms our longstanding position that Amgen's patents
claiming PCSK9 antibodies purely by their function are overly broad
and invalid," said Joseph LaRosa,
Executive Vice President, General Counsel and Secretary, Regeneron.
"Praluent was developed using Regeneron's proprietary technology,
and the Federal Circuit validated that Amgen has no claim to
Praluent or its development, helping to provide closure on this
matter."
This decision follows the October
2020 ruling by the European Patent Office's (EPO) Technical
Board of Appeal that also invalidated certain functional claims of
Amgen's European patent directed to PCSK9 antibodies.
Regeneron has sole rights for Praluent inside the U.S. and
Sanofi possesses sole rights for Praluent outside the U.S. Each
party is solely responsible for funding development and
commercialization expenses in their respective territories.
About Praluent (alirocumab)
Praluent (alirocumab)
inhibits the binding of PCSK9 to the low-density lipoprotein (LDL)
receptor and thereby increases the number of available LDL
receptors on the surface of liver cells to clear LDL, which lowers
LDL cholesterol (LDL-C) levels in the blood. Praluent was developed
by Regeneron and Sanofi under a global collaboration agreement and
invented by Regeneron using the company's proprietary
VelocImmune® technology that yields optimized
fully-human monoclonal antibodies.
Praluent is approved in more than 60 countries worldwide,
including the U.S., European Union (EU), Japan, Canada, Switzerland, Mexico and Brazil. In the U.S., Praluent is approved to
reduce the risk of heart attack, stroke and unstable angina
requiring hospitalization in adults with established cardiovascular
disease. Praluent is also approved as an adjunct to diet, alone or
in combination with other lipid-lowering therapies (e.g., statins,
ezetimibe), for the treatment of adults with primary hyperlipidemia
(including heterozygous familial hypercholesterolemia) to reduce
LDL-C.
Important Safety Information for the
U.S.
Do not use Praluent if you are allergic to
alirocumab or to any of the ingredients in Praluent.
Before you start using Praluent, tell your healthcare provider
about all your medical conditions, including allergies, and if you
are pregnant or plan to become pregnant or if you are breastfeeding
or plan to breastfeed.
Tell your healthcare provider or pharmacist about any
prescription and over-the-counter medicines you are taking or plan
to take, including natural or herbal remedies.
Praluent can cause serious side effects, including allergic
reactions that can be severe and require treatment in a hospital.
Call your healthcare provider or go to the nearest hospital
emergency room right away if you have any symptoms of an allergic
reaction including a severe rash, redness, severe itching, a
swollen face, or trouble breathing.
The most common side effects of Praluent include: redness,
itching, swelling, or pain/tenderness at the injection site,
symptoms of the common cold, and flu or flu-like symptoms. Tell
your healthcare provider if you have any side effect that bothers
you or that does not go away.
Talk to your doctor about the right way to prepare and give
yourself a Praluent injection and follow the "Instructions for Use"
that comes with Praluent.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing
Information.
About Regeneron
Regeneron (NASDAQ: REGN)
is a leading biotechnology company that invents life-transforming
medicines for people with serious diseases. Founded and led for
over 30 years by physician-scientists, our unique ability to
repeatedly and consistently translate science into medicine has led
to nine FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, infectious
diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
such as VelocImmune, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please
visit www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, risks associated with
intellectual property of other parties and pending or future
litigation relating thereto, including without limitation the
patent litigation pertaining to Praluent® (alirocumab)
discussed in this press release (as well as other patent litigation
and related proceedings pertaining to Praluent, EYLEA®
(aflibercept) Injection, Dupixent® (dupilumab), and
REGEN-COVTM (casirivimab and imdevimab)), the ultimate
outcome of any such proceedings, and the impact any of the
foregoing may have on Regeneron's business, prospects, operating
results, and financial condition; the impact of SARS-CoV-2 (the
virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized by
Regeneron and/or its collaborators (collectively, "Regeneron's
Products"), and the global economy; the nature, timing, and
possible success and therapeutic applications of Regeneron's
Products and product candidates being developed by Regeneron and/or
its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation Praluent; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's Product Candidates and new indications for Regeneron's
Products; uncertainty of market acceptance and commercial success
of Regeneron's Products (such as Praluent) and Regeneron's Product
Candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products and Regeneron's Product
Candidates; safety issues resulting from the administration of
Regeneron's Products and Regeneron's Product Candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and Regeneron's
Product Candidates in clinical trials; determinations by regulatory
and administrative governmental authorities which may delay or
restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and Regeneron's Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron's Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron's Products (such as Praluent)
from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to, or
more cost effective than, Regeneron's Products (including without
limitation Praluent) and Regeneron's Product Candidates; the extent
to which the results from the research and development programs
conducted by Regeneron and/or its collaborators may be replicated
in other studies and/or lead to advancement of product candidates
to clinical trials, therapeutic applications, or regulatory
approval; the ability of Regeneron to manufacture and manage supply
chains for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's Products and Regeneron's Product Candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; and the potential for any
license, collaboration, or supply agreement, including Regeneron's
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), to
be cancelled or terminated. A more complete description of these
and other material risks can be found in Regeneron's filings with
the U.S. Securities and Exchange Commission, including its Form
10-K for the year ended December 31,
2020. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contacts:
Media Relations
Joseph Ricculli
Tel: +1 (914) 418-0405
Joseph.Ricculli@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
Mark.Hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.