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Regeneron Pharmaceuticals : Sanofi : and Regeneron Announce 18,000-Patient ODYSSEY OUTCOMES Trial of Praluent® (alirocumab) Injection Fully Enrolled

11/24/2015 | 01:01am US/Eastern

                         Sanofi and Regeneron Announce
18,000-Patient ODYSSEY OUTCOMESTrial of Praluent(®) (alirocumab) Injection Fully

Paris  and  Tarrytown,  New  York  -  November  24, 2015 -  Sanofi and Regeneron
Pharmaceuticals,   Inc.  today  announced  that  the  companies  have  completed
enrollment  in the global Phase 3 ODYSSEY OUTCOMES trial, which is prospectively
evaluating   the   potential   cardiovascular   (CV)   benefits  of  Praluent(®)
(alirocumab)  Injection  after  an  acute  coronary  syndrome (ACS). The 18,000-
patient ODYSSEY OUTCOMES trial is expected to be completed in 2017.

ODYSSEY  OUTCOMES is designed  to determine whether  the addition of Praluent to
intensive statin therapy reduces major adverse cardiac events among patients who
had  previously experienced an ACS,  such as a heart  attack or unstable angina.
The  primary endpoint evaluates  the time to  first occurrence of coronary heart
disease death, acute myocardial infarction, hospitalization for unstable angina,
or  fatal and non-fatal ischemic stroke.  Patients with recent ACS were selected
as the study population because they face a higher risk of recurrent events than
patients with stable cardiovascular disease.

Praluent  is  currently  approved  in  the  U.S.  and  EU  to  reduce  bad (LDL)
cholesterol  in some patients with significant  unmet need, including those with
established  cardiovascular disease, or  an inherited form  of high cholesterol,
called heterozygous familial hypercholesterolemia (HeFH). The effect of Praluent
on CV morbidity and mortality has not been determined.

The  global ODYSSEY  program includes  16 Phase 3 trials  conducted at more than
2,000 study centers, around the world, and once complete will evaluate more than
25,000 patients.   Data   from   this  program  helped  form  one  of  the  most
comprehensive  data  sets  ever  used  for  the  initial  regulatory filing of a
cholesterol-lowering   therapy.   In  completed  trials,  Praluent  reduced  LDL
cholesterol  by up to an additional 62 percent versus placebo, and was generally
well-tolerated with an acceptable safety profile.

The ODYSSEY OUTCOMES trial design was published in the American Heart Journal in
November 2014.

About Praluent
In  July, the companies announced that Praluent was approved for use in the U.S.
Praluent  is a  PCSK9 (proprotein  convertase subtilisin/kexin type 9) inhibitor
indicated  as adjunct  to diet  and maximally  tolerated statin  therapy for the
treatment  of  adults  with  HeFH  or  clinical atherosclerotic CVD, who require
additional  lowering of LDL cholesterol. The  effect of Praluent on CV morbidity
and mortality has not been determined.

In  September, the European Commission  approved the marketing authorization for
Praluent.  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.

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 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

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

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 has core strengths in
diabetes  solutions,  human  vaccines,  innovative  drugs,  consumer healthcare,
emerging  markets,  animal  health  and  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,  atopic  dermatitis,  pain,  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, 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 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
evaluating   Praluent   discussed  in  this  news  release;  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 discussed in this news
release  prospectively  assessing  the  potential  of  Praluent  to  demonstrate
cardiovascular   benefit);   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; 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 September
30, 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.

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

Contacts Sanofi:

  Media Relations                 Investor Relations
  Jack Cox                        Sébastien Martel
  Tel: +33 (0) 1 53 77 94 74      Tel: +33 (0)1 53 77 45 45
  Mobile: +33 (0) 6 78 52 05 36   IR@sanofi.com

Global Communications, PCSK9 Development & Launch Unit
Elizabeth Baxter
Tel: +1 (908) 981.5360
Mobile: +1 (908) 340-7811

Contacts Regeneron:

  Media Relations                   Investor Relations
  Arleen Goldenberg                 Manisha Narasimhan, Ph.D.
  Tel: + 1 (914) 847-3456           Tel: +1 (914) 847-5126
  Mobile: +1 (914) 260-8788         manisha.narasimhan@regeneron.com

Press release (PDF): 

This announcement is distributed by GlobeNewswire on behalf of 
GlobeNewswire clients. The owner of this announcement warrants that: 
(i) the releases contained herein are protected by copyright and 
    other applicable laws; and 
(ii) they are solely responsible for the content, accuracy and 
     originality of the information contained therein. 
Source: Sanofi  via GlobeNewswire


© Thomson Reuters, source European Press Releases

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