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Sanofi : Appellate Court Orders a New Trial and Vacates Permanent Injunction in Ongoing Patent Case Regarding Praluent® (alirocumab)

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10/05/2017 | 06:30pm CEST

 Appellate Court Orders a New Trial and Vacates Permanent Injunction in Ongoing
                Patent Case Regarding Praluent(®) (alirocumab)



         - Praluent continues to be available to patients in the U.S. -



Paris,  France  and  Tarrytown,  N.Y.,  October  5, 2017 -  Sanofi and Regeneron
Pharmaceuticals,  Inc. today  announced that  the U.S.Court of Appeals for the
Federal  Circuit has ordered a new trial and vacated the permanent injunction in
the  dispute concerning Amgen's asserted  patent claims for antibodies targeting
PCSK9  (proprotein convertase  subtilisin/kexin type  9). This ruling means that
Sanofi   and  Regeneron  will  continue  marketing,  selling  and  manufacturing
Praluent(®) (alirocumab) injection in the U.S.

In  the decision, the  Federal Circuit ruled  that the trial  court erred by (1)
excluding  evidence  regarding  written  description;  (2) excluding evidence on
enablement;  (3) improperly instructing the jury on written description, holding
that  the law  requires "a  written description  of the  invention", meaning the
claimed  antibody  itself  and  not  the  antigen; and (4) improperly granting a
permanent injunction. The Federal Circuit affirmed the trial court's ruling that
Amgen's  patents  were  non-obvious,  which  was  one  of Sanofi and Regeneron's
several  challenges  to  validity  of  Amgen's  patents. Because of the improper
exclusion  of evidence,  the court  considered the  record to  be incomplete and
concluded at this time that Sanofi and Regeneron are not entitled to judgment as
a matter of law (JMOL) on the issues of written description and enablement.

The schedule for the new trial has not yet been determined. The companies do not
anticipate any new trial proceedings to start in 2017.

"We  are pleased with the  Federal Circuit's decision to  remand for a new trial
that  allows  us  to  present  our  complete  evidence  to the jury," said Karen
Linehan,  Executive  Vice  President  and  General  Counsel,  Sanofi. "It is our
longstanding  position that Amgen's  asserted patent claims  are invalid, and we
remain confident in the long-term availability of Praluent for patients."

Praluent  was the first PCSK9 antibody to  be approved for use in the U.S. It is
indicated  for use 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  "bad" (LDL) cholesterol. Praluent is the only PCSK9 antibody that offers two
biweekly  doses  (75  mg  and  150 mg)  with  two  levels  of efficacy, allowing
healthcare  providers the  flexibility to  adjust the  therapeutic dose based on
their  patient's LDL cholesterol-lowering needs. Praluent is also available as a
300 mg,  once-monthly dosing option (every four weeks) in the U.S. The effect of
Praluent on cardiovascular morbidity and mortality has not been determined.

"We continue to believe that the law and facts support our position, and we look
forward to presenting our complete evidence at trial to a new jury," said Joseph
J.  LaRosa,  Senior  Vice  President,  General Counsel and Secretary, Regeneron.
"Praluent  represents  an  important  medical  advancement  for patients, and we
remain  confident in  the meaningful  value that  Praluent provides  not only to
patients, but to the overall healthcare system."



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 Consumer Healthcare. Sanofi
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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 by
physician-scientists  for nearly 30 years, our  unique ability to repeatedly and
consistently  translate  science  into  medicine  has  led  to  six FDA-approved
treatments  and over a dozen product candidates,  all of which were homegrown in
our  laboratories. Our medicines and pipeline are designed to help patients with
eye  disease, heart disease,  allergic and inflammatory  diseases, pain, cancer,
and infectious and rare diseases.

Regeneron is accelerating and improving the traditional drug development process
through  its unique VelociSuite(®)  technologies, including VelocImmune(®) which
yields  optimized fully-human antibodies, and  ambitious initiatives such as the
Regeneron Genetics Center, 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.


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, risks
associated  with  intellectual  property  and  any  related  pending  or  future
litigation  and the  ultimate outcome  of such  litigation, including the patent
litigation  relating  to  Praluent,  the  uncertainties inherent in research and
development,  future  clinical  data  and  analysis,  including  post marketing,
unexpected  safety,  quality  or  manufacturing  issues, 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  or  Praluent,  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,  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, 2016. 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, risks associated with intellectual property
of  other parties and  pending or future  litigation relating thereto, including
the patent litigation relating to Praluent® (alirocumab) Injection, the ultimate
outcome  of such  litigation, and  the impact  any of  the foregoing may have on
Regeneron's business, prospects, operating results, and financial condition; 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;  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;  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;   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;  and the  potential for  any license  or collaboration
agreement,  including Regeneron's agreements with  Sanofi, Bayer HealthCare LLC,
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 United States Securities and
Exchange  Commission,  including  its  Form  10-K  for  the  year ended December
31, 2016 and  its Form  10-Q for  the quarterly  period ended June 30, 2017. 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).

Contact Sanofi:

  Media Relations
                              Investor Relations
  Ashleigh Koss
                              George Grofik
  Tel: +1 (908) 981-8745
                              Tel. +33 (0) 1 53 77 45 45
  Mobile: +1 (908) 205-2572
                              [email protected]
  [email protected]





Contact 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         [email protected]

  [email protected]









Press release (PDF): 
http://hugin.info/152918/R/2139808/819210.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
    
Source: Sanofi  via GlobeNewswire

 
  

© InPublic, source European Press Releases

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