BRIDGEWATER, N.J. and
TARRYTOWN, N.Y., Feb. 11, 2019 /PRNewswire/
-- Praluent® (alirocumab) will be made available at
a new reduced U.S. list price of $5,850 annually, a 60% reduction from the
original price, for both the 75 mg and 150 mg doses, beginning in
early March.
The new lower-priced Praluent is expected to result in lower
patient out-of-pocket costs and represents another step in the
companies' efforts to help improve patient affordability and
access. This follows an earlier announcement in March 2018, when Sanofi and Regeneron committed
to lower the U.S. net price for payers in return for helping to
reduce burdensome access barriers for appropriate patients.
"We were encouraged to see
improvements in accessibility following our collaboration with
payers last year to provide more straightforward, affordable access
to Praluent, but only some patients had reduced out-of-pocket
costs," said Michelle Carnahan,
North America Head of Primary Care Business Unit at Sanofi.
"With today's announcement, we are looking to help bridge that
gap, and have now made Praluent available at a price that is
approximately 60% lower. We hope that payers will do their part to
help ensure savings are directly passed on to more patients,
through lower out-of-pocket costs."
With the new lower-priced Praluent, most Medicare Part D
patients are expected to pay between $25 to $150 per
month, a potential savings of up to $345*, depending on their insurance plan.
Eligible commercial patients will continue to have access to copay
assistance through MyPraluent®.
*For illustrative purposes only, this calculation of monthly
savings (e.g., 2 Praluent doses) assumes a scenario where Praluent
is on a specialty tier with 33% co-insurance and Praluent then
moves to preferred brand tier co-pay of $25. Individual savings will vary according
to plan.
"In 2018, we lowered the
Praluent net price for health plans that were willing to improve
patient access and affordability. While lowering the net cost to
payers did improve access, seniors who were prescribed Praluent
were often still unable to afford it due to high co-pay costs or
co-insurance at many Medicare Part D plans," said Leonard S. Schleifer, MD, Ph.D., President and
Chief Executive Officer, Regeneron. "Offering a lower-priced
Praluent will help lower seniors' out-of-pocket costs and thereby
remove another barrier to receiving this important
medicine."
The new, lower-priced Praluent is expected to be available for
pharmacies to order in early March, and the doses with the original
list price will remain on the market at least through 2019. The
lower-priced Praluent will be identical to the Praluent currently
available, other than the list price.
To learn more about these changes, U.S. physicians and patients
can contact 1-800-633-1610 (press option 7, then option 5).
About Praluent
Praluent® (alirocumab)
Injection 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
to clear LDL, which lowers LDL-C levels in the blood. Praluent was
developed by Regeneron and Sanofi under a global collaboration
agreement.
Praluent is approved in more than 60 countries worldwide,
including the U.S., Japan,
Canada, Switzerland, Mexico, Brazil and the European Union. 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 or clinical
atherosclerotic cardiovascular disease who require additional
lowering of LDL-C. 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/safety/medwatch/ or call
1-800-FDA-1088.
Please click here for the full
Prescribing Information.
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 for 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting 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.
About
Sanofi
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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.
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With more than 100,000
people in 100 countries, Sanofi is transforming scientific
innovation into healthcare solutions around the globe.
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Sanofi, Empowering
Life
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Sanofi Media
Relations Contact
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Sanofi Investor
Relations Contact
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Ashleigh
Koss
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George
Grofik
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Tel: +1 (908)
981-8745
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Tel: +33 (0)1 53 77
45 45
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ashleigh.koss@sanofi.com
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ir@sanofi.com
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Regeneron Media
Relations Contact
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Regeneron Investor
Relations Contact
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Sarah
Cornhill
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Mark
Hudson
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Tel: +1 (914)
847-5018
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Tel: +1 (914)
847-3482
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sarah.cornhill@regeneron.com
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mark.hudson@regeneron.com
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Sanofi
Forward-Looking Statements
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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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. 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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks 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.
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Regeneron
Forward-Looking Statements and Use of Digital
Media
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This press 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; uncertainty of
market acceptance and commercial success of Regeneron's products
(such as Praluent) and product candidates; the availability and
extent of reimbursement of the Company's products (such as
Praluent) from third-party payers, including private payer
healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; the likelihood of success of
relevant strategies relating to Regeneron's products, such as the
pricing approach for Praluent discussed in this press release; 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; unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the extent to which the results from
the research and development programs conducted by Regeneron or its
collaborators may be replicated in other studies and lead to
therapeutic applications; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as
Praluent), research and clinical programs, and business, including
those relating to patient privacy; 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, including without
limitation Praluent; 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;
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; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its financial projections or guidance and
changes to the assumptions underlying those projections or
guidance; risks associated with intellectual property of other
parties and pending or future litigation relating thereto,
including without limitation the patent litigation and other
proceedings relating to Praluent, EYLEA® (aflibercept)
Injection, and Dupixent® (dupilumab) Injection, the
ultimate outcome of any such proceedings, and the impact any of the
foregoing may have on Regeneron's business, prospects, operating
results, and financial condition; and the potential for any license
or collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, 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 U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31,
2018. 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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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).
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Source: Sanofi
(EURONEXT: SAN) (NASDAQ: SNY)
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SOURCE Sanofi