| Sanofi
and Regeneron announce plans to make Praluent® more accessible and
affordable for patients with the greatest health risk and unmet
need Precision medicine approach will focus efforts on
high-risk patients, such as those who have had heart attacks or
unstable angina and cannot reduce their LDL-C below 100 mg/dL
despite maximally-tolerated statins For U.S. payers willing
to reduce access barriers for high-risk patients, companies will
offer net price within a cost-effective range, leveraging a new
ICER analysis Paris, France and Tarrytown, NY - March 10,
2018 - To help ensure more affordable and timely access to
patients most in need, Sanofi 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 PraluentPraluent
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.About RegeneronRegeneron (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 www.regeneron.com or follow @Regeneron on
Twitter. |
| Sanofi Forward-Looking StatementsThis 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
MediaThis 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. |