PARIS and TARRYTOWN, N.Y., Oct.
5, 2017 /PRNewswire/ -- Sanofi and Regeneron
Pharmaceuticals, Inc. 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
Sanofi and Regeneron's several challenges to 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:
|
|
|
|
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Mobile: +1 (908)
205-2572
Ashleigh.Koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel. +33 (0) 1 53 77
45 45
ir@sanofi.com
|
Contact
Regeneron:
|
|
|
|
Media
Relations
Arleen
Goldenberg
Tel: + 1 (914)
847-3456
Mobile: +1 (914)
260-8788
Arleen.Goldenberg@regeneron.com
|
Investor
Relations
Manisha Narasimhan, Ph.D.
Tel.: +1 (914) 847-5126
manisha.narasimhan@regeneron.com
|
SAUS.PRL.17.07.5688
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SOURCE Sanofi