TARRYTOWN, N.Y. and
PARIS, Feb.
25, 2019 /PRNewswire/ --
Praluent® (alirocumab) continues
to be available in the U.S.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
announced they strongly disagree with certain aspects of today's
jury verdict from the U.S. District Court for the District of
Delaware. The jury upheld the
validity of three of the five asserted claims of two Amgen U.S.
patents covering antibodies targeting PCSK9 (proprotein convertase
subtilisin/kexin type 9). The jury agreed with Regeneron and Sanofi
for two of the five asserted claims, finding they were invalid
based on lack of written description. The verdict does not impact
U.S. physicians' and patients' access to Praluent®
(alirocumab).
"We will continue to vigorously defend our positions against
Amgen's overly broad patent claims," said Joseph LaRosa, Executive Vice President, General
Counsel and Secretary, Regeneron. "We are considering our next
steps in this important case and continue to believe in the
differentiated clinical profile of Praluent."
Regeneron and Sanofi intend to file post-trial motions with the
District Court over the next few months, seeking to overturn the
jury verdict and also requesting a new trial. In addition, if
necessary the companies plan to appeal to the U.S. Court of Appeals
for the Federal Circuit. On February 8,
2019, the District Court dismissed Amgen's claim for willful
infringement.
"We are disappointed in today's verdict," said Karen Linehan, Executive Vice President and
General Counsel, Sanofi. "It is our longstanding belief that all of
Amgen's asserted U.S. patent claims are invalid and we believe the
law and the facts support our positions."
About Praluent
Praluent® (alirocumab) Injection 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-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., Japan,
Canada, Switzerland, Mexico, Brazil and the European Union. In the U.S.,
Praluent is approved for use as an adjunct to diet and
maximally-tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease who require additional
lowering of LDL-C. The effect of Praluent on cardiovascular
morbidity and mortality has not been determined.
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, neuromuscular diseases, infectious diseases 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 the patent litigation discussed in this press release,
the ultimate outcome of such litigation, and the impact it may have
on Regeneron's business, prospects, operating results, and
financial condition; the likelihood of success of any post-trial
motions or other appeals relating to the jury verdict discussed in
this press release; 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®
(alirocumab) Injection; 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. 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 future 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,
2017. 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
Sarah
Cornhill
Tel: +1 (917)
297-1522
sarah.cornhill@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914)
847-3482
mark.hudson@regeneron.com
|
Media
Relations
Nicolas
Kressmann
Tel: +1 (732)
532-5318
nicolas.kressman@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.