TARRYTOWN, N.Y. and
PARIS, Aug.
28, 2019 /PRNewswire/ --
Court rules in favor of Regeneron and Sanofi in ongoing
Praluent® (alirocumab) patent
litigation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi announced today that the U.S. District Court for the
District of Delaware ruled in
their favor and found as a matter of law that Amgen's asserted
patent claims for antibodies targeting PCSK9 (proprotein convertase
subtilisin/kexin type 9) are invalid based on lack of
enablement.
"Today's decision by the U.S. District Court for the District of
Delaware validates our position
that Amgen's patents are overly broad and invalid," said
Joseph LaRosa, Executive Vice
President, General Counsel and Secretary, Regeneron. "Praluent was
developed using Regeneron's proprietary science and technology and
the judge has confirmed our position by issuing this ruling."
Today's ruling overturned portions of an earlier jury verdict
upholding the validity of three claims. On February 25, 2019, a jury previously found in
Regeneron and Sanofi's favor that two other asserted Amgen patent
claims are invalid. This means that Regeneron and Sanofi have
successfully invalidated all five asserted Amgen patent
claims.
"It has been our longstanding belief that all of Amgen's
asserted U.S. PCSK9 patent claims are invalid, and we are pleased
today's decision reaffirms this," said Karen Linehan, Executive Vice President and
General Counsel, Sanofi.
About Praluent
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 Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, 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, infectious diseases,
pain and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Regeneron 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)
Injection discussed in this press release (as well as other patent
litigation and related proceedings pertaining to Praluent), 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 nature, timing, and possible
success and therapeutic applications of Regeneron's products,
product candidates, and research and clinical programs now underway
or planned, including without limitation Praluent; uncertainty of
market acceptance and commercial success of Regeneron's products
(such as Praluent) and product candidates; the availability and
extent of reimbursement of the Company'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; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for
marketed products; unforeseen safety issues resulting from the
administration of products and product candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron's product candidates in clinical trials; the
extent to which the results from the research and development
programs conducted by Regeneron or its collaborators may be
replicated in other studies and lead to therapeutic applications;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products (such as Praluent), research and clinical
programs, and business, including those relating to patient
privacy; 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 product candidates, including without limitation
Praluent; the impact of studies (whether conducted by Regeneron or
others and whether mandated or voluntary) on the commercial success
of Regeneron's products and product candidates; competing drugs and
product candidates that may be superior to Regeneron's products and
product candidates; 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 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 or collaboration 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 without any further product success. 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, 2018 and its Form 10-Q for the
quarterly period ended June 30, 2019.
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 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).
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related litigation and the ultimate
outcome of such litigation, and volatile economic conditions, as
well as those risks discussed or identified in the public filings
with the SEC and the AMF made by Sanofi, including those listed
under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2018.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
Regeneron
Contacts:
|
Sanofi
Contacts:
|
|
|
Media
Relations
Joe
Ricculli
Tel: +1 (914)
847-0405
joseph.ricculli@regeneron.com
Investor
Relations
Justin
Holko
Tel: +1 (914)
450-3514
justin.holko@regeneron.com
|
Media
Relations Nicolas Kressmann
Tel: +1 (732) 532-5318
nicolas.kressmann@sanofi.com
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.