TARRYTOWN, N.Y. and
PARIS, Feb.
8, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi announced today that the United States Court of Appeals for the
Federal Circuit has stayed (suspended) the permanent injunction for
Praluent® (alirocumab) Injection pending the companies'
appeal. This ruling (available here) means that Sanofi and
Regeneron will continue marketing, selling and manufacturing
Praluent in the U.S. during the appeal process. Sanofi and
Regeneron remain committed to ensuring patients who can benefit
from Praluent continue to have access to this innovative
therapy.
"This decision is important for patients in the U.S. who will
continue to have access to Praluent during the appeal process
giving them a choice in PCSK9 inhibitor treatments to best meet
their individual needs," 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 look forward to moving forward
with the appeal process."
The companies are challenging both the injunction ruling and
validity judgment during the appeal process. The companies believe
Amgen's asserted patent claims for antibodies targeting PCSK9
(proprotein convertase subtilisin/kexin type 9) are invalid in the
ongoing U.S. patent infringement lawsuit.
"We continue to believe the facts and controlling law support
our position in this case," said Joseph
J. LaRosa, Senior Vice President, General Counsel and
Secretary, Regeneron. "We will continue to vigorously defend our
case through the appeal process."
Praluent was the first PCSK9 inhibitor 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
inhibitor that offers two 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. The effect of Praluent on
cardiovascular morbidity and mortality has not yet been
determined.
The injunction (which has been suspended as noted above) is not
applicable outside the U.S. or to clinical trials which are
continuing as planned. Outside the U.S., Praluent is marketed and
sold in 15 countries with anticipated launches in 15 additional
countries in 2017.
Important Safety Information for 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 science-based biopharmaceutical company
based in Tarrytown, New York that
discovers, invents, develops, manufactures, and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for high LDL cholesterol, eye
diseases, and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including oncology, rheumatoid arthritis, asthma, atopic
dermatitis, pain, and infectious diseases. 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, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
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, 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, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, 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, 2015.
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 discussed
in this news release, any future decision in such litigation by
the United States Court of Appeals
for the Federal Circuit, the ultimate outcome of such
litigation, and the impact it 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® (alirocumab) Injection; 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 and 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, 2015 and its Form 10-Q for the
quarterly period ended September 30,
2016. 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).
Contacts Sanofi:
Media
Relations
Ashleigh
Koss
Tel.: +1 (908)
981-8745
ashleigh.koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
|
|
Contacts 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
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/appeals-court-grants-stay-of-permanent-injunction-for-praluent-alirocumab-during-appeals-process-300404629.html
SOURCE Regeneron Pharmaceuticals, Inc.