TARRYTOWN, N.Y. and
PARIS, Oct.
5, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the U.S.
Court of Appeals for the Federal Circuit has ordered a new trial
and vacated the permanent injunction in the dispute concerning
Amgen's asserted patent claims for antibodies targeting PCSK9
(proprotein convertase subtilisin/kexin type 9). This ruling means
that Sanofi and Regeneron will continue marketing, selling and
manufacturing Praluent® (alirocumab) injection in the
U.S.
In the decision, the Federal Circuit ruled that the trial court
erred by (1) excluding evidence regarding written description; (2)
excluding evidence on enablement; (3) improperly instructing the
jury on written description, holding that the law requires "a
written description of the invention", meaning the claimed antibody
itself and not the antigen; and (4) improperly granting a permanent
injunction. The Federal Circuit affirmed the trial court's ruling
that Amgen's patents were non-obvious, which was one of Regeneron
and Sanofi's several challenges to the validity of Amgen's patents.
Because of the improper exclusion of evidence, the court considered
the record to be incomplete and concluded at this time that
Regeneron and Sanofi are not entitled to judgment as a matter of
law (JMOL) on the issues of written description and enablement.
The schedule for the new trial has not yet been determined. The
companies do not anticipate any new trial proceedings to start in
2017.
"We are pleased with the Federal Circuit's decision to remand
for a new trial that allows us to present our complete evidence to
the jury," said Karen Linehan,
Executive Vice President and General Counsel, Sanofi. "It is our
longstanding position that Amgen's asserted patent claims are
invalid, and we remain confident in the long-term availability of
Praluent for patients."
Praluent was the first PCSK9 antibody to be approved for use in
the U.S. It is indicated for use as 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 "bad" (LDL) cholesterol. Praluent is the only PCSK9
antibody that offers two biweekly doses (75 mg and 150 mg) with two
levels of efficacy, allowing healthcare providers the flexibility
to adjust the therapeutic dose based on their patient's LDL
cholesterol-lowering needs. Praluent is also available as a 300 mg,
once-monthly dosing option (every four weeks) in the U.S. The
effect of Praluent on cardiovascular morbidity and mortality has
not been determined.
"We continue to believe that the law and facts support our
position, and we look forward to presenting our complete evidence
at trial to a new jury," said Joseph J.
LaRosa, Senior Vice President, General Counsel and
Secretary, Regeneron. "Praluent represents an important medical
advancement for patients, and we remain confident in the meaningful
value that Praluent provides not only to patients, but to the
overall healthcare system."
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 Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
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 by physician-scientists for nearly 30 years, our
unique ability to repeatedly and consistently translate science
into medicine has led to six FDA-approved treatments and over a
dozen product candidates, all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its unique VelociSuite®
technologies, including VelocImmune® which yields
optimized fully-human antibodies, and ambitious initiatives such as
the Regeneron Genetics Center, 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.
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 and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
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, risks associated with intellectual property and any related
pending or future litigation and the ultimate outcome of such
litigation, including the patent litigation relating to Praluent,
the uncertainties inherent in research and development, future
clinical data and analysis, including post marketing, unexpected
safety, quality or manufacturing issues, decisions by regulatory
authorities, such as the FDA or the EMA, regarding whether and when
to approve any drug, device or biological application that may be
filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates or
Praluent, the absence of guarantee that the product candidates if
approved will be commercially successful, the future approval and
commercial success of therapeutic alternatives, Sanofi's ability to
benefit from external growth opportunities and/or obtain regulatory
clearances, trends in exchange rates and prevailing interest rates,
volatile economic conditions, the impact of cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those 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,
2016. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Regeneron Forward-Looking Statements and Use of Digital
Media
This news 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
relating to Praluent® (alirocumab) Injection, the ultimate outcome
of such litigation, 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; unforeseen safety issues and possible
liability resulting from the administration of products (including
without limitation Praluent) and product candidates in patients;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates in clinical trials,
such as the ODYSSEY OUTCOMES trial prospectively assessing the
potential of Praluent to demonstrate cardiovascular benefit;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products (such as Praluent), research and clinical
programs, and business, including those relating to the enrollment,
completion, and meeting of the relevant endpoints of post-approval
studies (such as the ODYSSEY OUTCOMES trial); 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; 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; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and 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 product candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; coverage and reimbursement determinations by
third-party payers, including Medicare and Medicaid; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its sales or other
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 HealthCare LLC, 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 United States Securities and Exchange Commission, including its
Form 10-K for the year ended December 31,
2016 and its Form 10-Q for the quarterly period ended
June 30, 2017. 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).
Contact
Sanofi:
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Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Mobile: +1 (908)
205-2572
Ashleigh.Koss@sanofi.com
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Investor
Relations
George
Grofik
Tel. +33 (0) 1 53 77
45 45
ir@sanofi.com
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Contact
Regeneron:
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Media
Relations
Arleen
Goldenberg
Tel: + 1 (914)
847-3456
Mobile: +1 (914)
260-8788
Arleen.Goldenberg@regeneron.com
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Investor
Relations
Manisha Narasimhan, Ph.D.
Tel.: +1 (914) 847-5126
manisha.narasimhan@regeneron.com
|
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content:http://www.prnewswire.com/news-releases/appellate-court-orders-a-new-trial-and-vacates-permanent-injunction-in-ongoing-patent-case-regarding-praluent-alirocumab-300531909.html
SOURCE Regeneron Pharmaceuticals, Inc.