PARIS and TARRYTOWN, N.Y., March
10, 2018 /PRNewswire/ -- To help ensure more affordable
and timely access to patients most in need, Sanofi (EURONEXT: SAN)
(NYSE: SNY) and Regeneron Pharmaceuticals, will offer U.S.
payers that agree to reduce burdensome access barriers for
high-risk patients a further reduced net price for Praluent®
(alirocumab) Injection in alignment with a new value assessment for
high-risk patients from the U.S. Institute for Clinical and
Economic Review (ICER).
The companies will take a precision medicine approach, to
address the burden of cardiovascular disease, focusing efforts on
high-risk patients most vulnerable for future cardiovascular (CV)
events, such as those who have suffered a previous coronary event
and are unable to reduce their LDL cholesterol (LDL-C) below 100
mg/dL despite maximally-tolerated statin therapy.
In keeping with ICER's established "in confidence" procedures,
Sanofi and Regeneron provided early access to data from the ODYSSEY
OUTCOMES trial to ICER, an independent organization that evaluates
the value of prescription drugs and other health care innovations,
to enable a revised assessment of alirocumab value incorporating
the ODYSSEY OUTCOMES results.
"Inventing innovative medicines
only matters if the people who need these products are able to
access them – and that is unfortunately not the case with Praluent
today," said Leonard S. Schleifer,
MD, PhD, President and Chief Executive Officer of Regeneron.
"We believe a new paradigm is needed in how all members of the
healthcare community collaborate to ensure that patients are able
to affordably access medical treatments they need. We commit to
working with all health plans that agree to remove access barriers
for high-risk patients to offer a more cost-effective net price for
Praluent. We hope that our unprecedented approach to collaborating
with payers and other stakeholders demonstrates that it is possible
to bring major innovation to patients at a price that aligns with
the value delivered."
"Too many patients in urgent
need of additional treatment options on top of statins have faced
tremendous hurdles to gain access to this important medicine. We
are prepared to improve access and affordability, eliminating
burdensome barriers for high-risk patients in need," said
Olivier Brandicourt, MD, Chief
Executive Officer of Sanofi. "We will begin working with payers to
ensure that high-risk patients have appropriate access. This is the
right thing to do for patients."
Sanofi and Regeneron will be meeting with U.S. health plans to
discuss potential net pricing adjustments for those that agree to
provide straightforward access for high-risk patients. The
companies plan to work with cardiology healthcare professionals to
define best practices in terms of reducing barriers to access in
order to ensure that patients in need have their prescriptions
filled quickly and efficiently.
About Praluent
Praluent inhibits the binding of PCSK9
(proprotein convertase subtilisin/kexin type 9) to the LDL receptor
and thereby increases the number of available LDL receptors on the
surface of liver cells, which lowers LDL-C levels in the
blood. The use of Praluent to reduce the risk of major
adverse CV events is investigational and has not been evaluated by
any regulatory agency.
Praluent is approved in more than 60 countries worldwide,
including the U.S., Japan,
Canada, Switzerland, Mexico and Brazil, as well as the European Union
(EU).
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 (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD) who require
additional lowering of LDL-C.
In the EU, Praluent is approved for the treatment of adult
patients with primary hypercholesterolemia (HeFH and non-familial)
or mixed dyslipidemia as an adjunct to diet: a) in combination with
a statin, or statin with other lipid-lowering therapies in patients
unable to reach their LDL-C goals with the maximally-tolerated
statin or b) alone or in combination with other lipid-lowering
therapies for patients who are statin intolerant, or for whom a
statin is contraindicated.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions.
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
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 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, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary VelociSuite®
technologies, including VelocImmune® to yield 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
http://www.regeneron.com or follow @Regeneron on Twitter.
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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
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Sanofi Media
Relations Contact
Ashleigh
Koss
Tel: +1 (908) 981
8745
mr@sanofi.com
Regeneron Media
Relations Contact
Sarah
Cornhill
Mobile: +1 (917)
297-1522
Sarah.Cornhill@regeneron.com
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Sanofi Investor
Relations Contact
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
Regeneron Investor
Relations Contact
Manisha Narasimhan,
Ph.D.
Tel: 1 (914)
847-5126
Manisha.Narasimhan@regeneron.com
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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, 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
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,
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; the
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), including the ODYSSEY OUTCOMES trial
referenced in this news release, on the commercial success of
Regeneron's products and product candidates; coverage and
reimbursement determinations by third-party payers (such as
Medicare and Medicaid), including those impacting further
commercialization of Praluent; the likelihood of success of
relevant strategies relating to Regeneron's products, such as the
new precision-medicine approach for Praluent discussed in this news
release; 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; 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; 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; the ability of Regeneron to manufacture and manage
supply chains for multiple products and product candidates;
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; 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 canceled or terminated without any
further product success; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto, including the patent litigation proceedings relating to
Praluent, the ultimate outcome of any such litigation proceedings,
and the impact any of the foregoing may have on Regeneron's
business, prospects, operating results, and financial condition. 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, 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.
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SAUS.PRL.18.03.1548
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