TARRYTOWN, N.Y. and
PARIS, July
24, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S.
Food and Drug Administration (FDA) approved Praluent®
(alirocumab) Injection, the first FDA-approved treatment in a new
class of drugs known as PCSK9 (proprotein convertase
subtilisin/kexin type 9) inhibitors. Praluent is indicated as an
adjunct to diet and maximally tolerated statin therapy for the
treatment of adults with heterozygous familial hypercholesterolemia
or clinical atherosclerotic cardiovascular disease (ASCVD) who
require additional lowering of low-density lipoprotein (LDL)
cholesterol. The effect of Praluent on cardiovascular morbidity and
mortality has not been determined.
Praluent is the first and only PCSK9 inhibitor approved in the
U.S. and is available in two different doses (75 mg and 150 mg).
Both doses of Praluent are available in a single 1 milliliter (mL)
injection delivered in a single-dose prefilled pen or syringe that
patients self-administer every two weeks.
"For patients with high LDL, or bad, cholesterol the primary
focus of treatment is to lower their levels, but many patients
today do not achieve recommended levels despite lifestyle
modifications and treatment with statins," said Christopher Cannon, M.D., Professor of Medicine
at Harvard Medical School,
Cardiovascular Division at Brigham and Women's Hospital, and a
member of the Steering Committee for the Phase 3 ODYSSEY clinical
trial program. "In the ODYSSEY clinical trial program, two doses of
alirocumab showed significant LDL cholesterol lowering in a variety
of patients who were not able to adequately lower their LDL
cholesterol with current standard of care alone. The majority
of patients achieved their LDL-lowering goals with the 75 mg dose,
when added to maximally tolerated dose of a statin, with a
generally acceptable safety profile."
Many patients in the U.S. face the challenge of achieving LDL
cholesterol levels recommended by healthcare providers, despite
treatment with standard of care including statins. These include
approximately 8-10 million patients with an inherited form of high
LDL cholesterol known as heterozygous familial hypercholesterolemia
and those with clinical ASCVD, defined as a build-up of plaque in
the arteries which can lead to reduced blood flow and a number of
conditions including heart attack, stroke, chest pain (stable or
unstable angina), transient ischemic attack, revascularization and
peripheral artery disease.
"Despite significant progress over the last decades, high
cholesterol remains a leading concern in the U.S. and globally,"
said Olivier Brandicourt, M.D.,
Chief Executive Officer, Sanofi. "Praluent demonstrates the power
of the Sanofi and Regeneron alliance to deliver a first-in-class
therapy in the U.S. for patients in need. Sanofi has a strong
cardiovascular heritage and dedication to these patients, and we
look forward to working with other regulatory authorities to make
Praluent available to patients worldwide."
"We are grateful to the thousands of patients and investigators
worldwide who participated in the ODYSSEY clinical trial program,"
said Leonard S. Schleifer, M.D.,
Ph.D., Founder, President, and Chief Executive Officer, Regeneron.
"Praluent represents the culmination of more than a decade of
tireless work to translate the genetic-based discovery of PCSK9
into an innovative medicine that brings meaningful value to
patients."
The approval of Praluent was based on data from the pivotal
Phase 3 ODYSSEY program, which showed consistent, positive results
compared to placebo, which included current standard of care
therapy (statins). In the ODYSSEY LONG TERM trial which evaluated
Praluent 150 mg every two weeks, Praluent reduced LDL cholesterol
by 58 percent versus placebo at week 24 when added to current
standard of care, including maximally tolerated statins. In ODYSSEY
COMBO I, Praluent 75 mg every two weeks as an adjunct to statins
reduced LDL cholesterol by an additional 46 percent compared to
placebo at week 12. At week 24 in the same trial, Praluent reduced
LDL cholesterol by 43 percent compared to placebo. In this study,
if additional LDL cholesterol lowering was required based on
pre-specified criteria at week 8, Praluent was up-titrated to 150
mg at week 12 for the remainder of the trial. Eighty-three percent
of patients remained on their initial 75 mg dose.
Praluent is generally well-tolerated with an acceptable safety
profile. Local injection site reactions including redness, itching,
swelling or pain/tenderness where the injection is given were the
most common events (7.2 percent with Praluent versus 5.1 percent
with placebo) and resulted in a low discontinuation rate that was
comparable to placebo (0.2 percent with Praluent versus 0.4 percent
with placebo). Patients receiving Praluent had a greater number of
injection site reactions, had more reports of associated symptoms,
and had reactions of longer average duration than patients
receiving placebo. Other common adverse events occurring more
frequently in patients with Praluent than placebo included symptoms
of the common cold and flu or flu-like symptoms.
The companies carefully considered the potential medical value
that Praluent offers patients in determining the Wholesale
Acquisition Cost (WAC). The U.S. WAC price of Praluent is
$40 per day ($1,120 every 28 days) for both the 75 mg and 150
mg doses, making Praluent the lowest priced patient-administered
monoclonal antibody therapy on an annualized basis. Actual costs to
patients, payers and health systems are anticipated to be lower as
WAC pricing does not reflect discounts or rebates. Out-of-pocket
costs to patients will vary depending on insurance status and
eligibility for patient assistance.
Sanofi and Regeneron are committed to ensuring that patients in
the U.S. who are prescribed Praluent are able to access the
medicine and receive the support they may need. The companies will
launch a comprehensive program that offers support, training and
follow up for patients at every step of the process. The program
will provide patient assistance to uninsured or underinsured
patients, including providing free medicine to eligible
patients, and can help identify coverage options for out-of-pocket
costs. Additional services include educational information,
clinical support for physicians, nurses and pharmacists, as well as
reimbursement services, including co-pay support for eligible
patients and information about insurance eligibility support. For
more information, please call 1-844-PRALUENT
(1-844-772-5836).
Earlier today, the companies announced that the European
Medicine Agency's (EMA's) Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion for the marketing
authorization of Praluent, recommending its approval for use in
certain adult patients with hypercholesterolemia. The European
Commission (EC) is expected to make a final decision on the
Marketing Authorization Application for Praluent in the European
Union in September 2015.
Investor Relations Conference Call on Praluent
Sanofi
and Regeneron will be hosting a conference call for the financial
community on Praluent® (alirocumab) Injection for the
treatment of high LDL cholesterol in adult patients. The conference
call will take place on Friday, July 24,
2015 (21:30 CET / 20:30 BST/ 15:30
EDT / 12:30 PDT).
The call will be available through audio webcast at
www.sanofi.com and www.regeneron.com and also via the following
telephone numbers:
France:
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+33 (0) 1 70 80 71 53
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UK:
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+44 (0) 203 107 0289
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U.S.:
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+1 888 660 6127
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Access code:
81662098
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ODYSSEY Program
The ODYSSEY Phase 3 program is one of
the most comprehensive clinical trial programs ever conducted for
an investigational LDL cholesterol lowering therapy. The program
includes 14 global Phase 3 trials evaluating more than 23,500
patients. The primary efficacy end point in all of the studies was
the mean percent reduction from baseline in LDL cholesterol at week
24 compared to placebo (maximally tolerated statin therapy); all of
the completed studies met their primary endpoint. A significantly
higher proportion of patients achieved LDL cholesterol of less than
70 mg/dL in the Praluent group as compared to placebo at both week
12 and week 24. The ongoing ODYSSEY OUTCOMES trial will
prospectively evaluate the cardiovascular benefits of Praluent in
approximately 18,000 patients.
Important Safety Information
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, an integrated global healthcare
leader, discovers, develops and distributes therapeutic solutions
focused on patients' needs. Sanofi has core strengths in the field
of healthcare with seven growth platforms: diabetes solutions,
human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. 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 and atopic
dermatitis. For additional information about the company, please
visit www.regeneron.com.
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,
the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies 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, 2014. 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
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"), 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; 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
evaluating Praluent; 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 evaluating Praluent; 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, including without limitation
Praluent; the impact of the opinion adopted by the European
Medicine Agency's Committee for Medicinal Products for Human Use
discussed in this news release on the European Commission's
decision regarding the Marketing Authorization Application for
Praluent in the European Union; 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; the potential for any license or collaboration agreement,
including Regeneron's agreements with Sanofi and Bayer HealthCare
LLC, to be cancelled or terminated without any further product
success; and risks associated with intellectual property of other
parties and pending or future litigation relating thereto. 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, 2014 and its Form 10-Q
for the quarterly period ended March 31,
2015. 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.
Contacts
Sanofi:
|
|
|
|
Media
Relations
Jack
Cox
Tel: +33 (0) 1 53 77
94 74
Mobile: +33 (0) 6 78
52 05 36
Jack.Cox@sanofi.com
Global
Communications, PCSK9 Development & Launch Unit
Elizabeth
Baxter
Tel: +1 (908)
981-5360
Mobile: +1 (908)
340-7811
Elizabeth.Baxter@sanofi.com
U.S.
Communications
Carrie
Brown
Tel: +1 (908)
981-6486
Mobile: +1 (908)
247-6006
Carrie.Brown@sanofi.com
|
Investor
Relations
Sebastien
Martel
Tel: +33 (0)1 53 77
45 45
IR@sanofi.com
|
Contacts
Regeneron:
|
|
|
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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
|
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SOURCE Regeneron Pharmaceuticals, Inc.