TARRYTOWN, N.Y. and
BRIDGEWATER, N.J., Nov. 11, 2016 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that data from the Praluent® (alirocumab)
Injection ODYSSEY clinical trial program will be presented at the
American Heart Association's (AHA) Scientific Sessions 2016 in
New Orleans, Louisiana, from
November 12-16.
Analyses of pooled data from the pivotal Phase 3 ODYSSEY
clinical trial program include a presentation on the ability for
patients to attain their LDL cholesterol goals with Praluent versus
ezetimibe. An analysis from the ODYSSEY CHOICE I trial evaluating
Praluent as a monthly (every four weeks) dose will also be
presented. Other data presentations evaluate the real world
use or potential health impact of PCSK9 inhibitors and other
lipid-lowering therapies.
Praluent is a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type
9) inhibitor antibody indicated 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 LDL-C. The effect of Praluent on cardiovascular
morbidity and mortality has not been determined. Praluent is
contraindicated in patients with a history of a serious
hypersensitivity reaction to Praluent. Reactions have included
hypersensitivity vasculitis and hypersensitivity reactions
requiring hospitalization.
Sanofi and Regeneron data is featured in 16 abstracts at the AHA
Scientific Sessions 2016. Key data highlights include:
Praluent data:
1) ORAL PRESENTATION
- Metabolic Syndrome, Dysglycemia, and Dyslipidemia:
Diagnostic, Prognostic, and Therapeutic Aspects
- Pharmacodynamic Relationship Between PCSK9, Alirocumab, and
LDL-C Lowering in the ODYSSEY CHOICE I Trial (Roth)
- Abstract # 685
- Monday, November 14, 2:00-2:05 p.m. CT (Science and Technology Hall,
Population Science Theater)
2) POSTER PRESENTATIONS
- Preventive Interventions: Population and Clinical Trials
- Treatment Effect of Alirocumab in Patients With Heterozygous
Familial Hypercholesterolemia With Baseline Low-density Lipoprotein
Cholesterol Levels >130 mg/dL Receiving High Intensity Statin
(Kastelein)
- Abstract # M2013
- Monday, November 14, 10:45 a.m.-12:00 p.m. CT (Science and Technology
Hall, Population Science Section)
- Comparison of Low-density Lipoprotein Cholesterol Threshold
Attainment With Alirocumab versus Ezetimibe Treatment in the
ODYSSEY Program (Cannon)
- Abstract # M2014
- Monday, November 14, 10:45 a.m.-12:00 p.m. CT (Science and Technology
Hall, Population Science Section)
Additional data of interest:
1) ORAL PRESENTATION
- Risk Assessment and Prevention
- Impact of Communication Format and Risk Horizon on Patient
Perceptions of CVD Risk: Findings From the PALM Registry (Navar)
- Abstract # 781
- Tuesday, November 15,
12:20-12:25 p.m. CT (Science and
Technology Hall, Population Science Theater)
2) POSTER PRESENTATIONS
- Epidemiology and Population Studies in Cardiovascular
Disease Session I
- From Clinical Trial to Clinical Setting: What are the Observed
Prescribing Behaviors in the United
States Since the Launch of PCSK9 Inhibitors? (Karalis)
- Abstract # S2167
- Sunday, November 13, 3:45-5:00 p.m. CT (Science and Technology Hall,
Population Science Section)
- Epidemiology and Population Studies: Statins and Statin
Adherence
- Simulation of Impact on Cardiovascular Events With
Lipid-lowering Treatment Intensification in Patients With
Atherosclerotic Cardiovascular Disease in the US (Cannon)
- Abstract # T2014
- Tuesday, November 15,
10:45 a.m.-12:00 p.m. CT (Science and
Technology Hall, Population Science Section)
Further information on AHA Scientific Sessions 2016 is available
on the congress website.
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 results in lower LDL cholesterol
levels in the blood. Praluent is the only PCSK9 inhibitor available
in two dosages with two levels of efficacy (75 mg and 150 mg),
allowing physicians to select the dose based on a patient's LDL
cholesterol lowering needs.
Praluent is approved in approximately 40 countries worldwide,
including the U.S., Japan,
Canada, Switzerland, Mexico, Brazil and the European Union (EU). In the
U.S., Praluent is approved for use as adjunct to diet and maximally
tolerated statin therapy for the treatment of adults with HeFH or
clinical atherosclerotic CV disease, who require additional
lowering of LDL cholesterol. In the E.U., 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
cholesterol 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. The effect of Praluent on CV morbidity and
mortality has not yet been determined. ODYSSEY OUTCOMES is
prospectively evaluating the effect of Praluent on the occurrence
of CV events in approximately 18,000 patients who have experienced
an acute coronary syndrome.
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.
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 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 Merial. 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
that discovers, invents, develops, manufactures and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, high LDL
cholesterol and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including rheumatoid arthritis, atopic dermatitis, asthma,
pain, cancer 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, 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; coverage and reimbursement determinations
by third-party payers, including Medicare, Medicaid, and pharmacy
benefit management companies; 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; 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 (or their respective affiliated
companies, as applicable), 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, 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
Katherine Hamlet
Tel: +1 (908) 981-5848
Mobile: +1 (215) 219-9087
Katherine.Hamlet@sanofi.com
Contacts Regeneron:
Media Relations
Arleen Goldenberg
Tel: + 1 (914) 847-3456
Mobile: +1 (914) 260-8788
Arleen.Goldenberg@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.