Bli medlem
Bli medlem

Du är här


Sanofi : Sanofi and Regeneron Announce Praluent® (alirocumab) Cardiovascular Outcomes Trial will Continue as Planned Following Interim Analysis

Sanofi and Regeneron Announce Praluent®(alirocumab) Cardiovascular Outcomes
Trial will Continue as Planned Following Interim Analysis



is designed to prospectively assess the effect of Praluent on cardiovascular
events in high-risk patients -

Paris, France and Tarrytown, New York - November 17, 2016
SanofiandRegeneron Pharmaceuticals, announced that the ongoing
Praluent®(alirocumab) ODYSSEY OUTCOMES trial will continue as planned, based
on the recommendation of an independent Data Monitoring Committee (DMC) after
it completed a second pre-specified interim analysis. The DMC will continue
to monitor the ongoing safety and efficacy of Praluent as planned.

The Phase 3, multi-center, randomized, double-blind, placebo-controlled
ODYSSEY OUTCOMES trial involves more than 18,000 patients from 57 countries.
All patients who entered the trial had experienced a heart attack or unstable
angina requiring hospitalization within a year of entering the trial, and
were unable to control their LDL cholesterol despite receiving
maximally-tolerated statins and potentially other lipid-lowering therapies.
Patients receiving maximally-tolerated statin therapy were randomized to
receive either Praluent 75 milligrams (mg) every two weeks or placebo.
Patients on Praluent had their dose increased to 150 mg every two weeks at
week 8 if their LDL cholesterol remained above 50 milligrams/deciliter


1 Schwartz GG, Bessac L, Berdan LB, et al. Effect of alirocumab, a monoclonal
antibody to PCSK9, on long-term cardiovascular outcomes following acute
coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial.
American Heart Journal. November 2014; 168 (5):682-689

About Praluent

Praluent is a human monoclonal antibody that 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 currently 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
heterozygous familial hypercholesterolemia (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 orb)
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.

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.

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 visitwww.regeneron.comor follow @Regeneron on

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 regarding the clinical development of and
potential marketing approvals for sarilumab. Forward-looking statements are
generally identified by the words "expects", "anticipates", "believes",
"intends", "estimates", "plans", "would be" 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 of sarilumab, 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 sarilumab or biological application
that may be filed for sarilumab as well as their decisions regarding
labeling and other matters that could affect the availability or commercial
potential of sarilumab, the absence of guarantee that sarilumab if approved
will be commercially successful, risks associated with intellectual property,
future litigation, the future approval and commercial success of therapeutic
alternatives, 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, 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 discussed in this news release, which is prospectively
assessing the potential of Praluent to demonstrate cardiovascular benefit;
the timing of completion of the ODYSSEY OUTCOMES trial; 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; risks associated with
intellectual property of other parties and pending or future litigation
relating thereto; 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; and 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. 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 s...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.