Sanofi : Appellate Court Orders a New Trial and Vacates Permanent Injunction in Ongoing Patent Case Regarding Praluent® (alirocumab)
(Thomson Reuters ONE) -
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 (at)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
ir(at)sanofi.com
Ashleigh.Koss(at)sanofi.com
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 manisha.narasimhan(at)regeneron.com
Arleen.Goldenberg(at)regeneron.com
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
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