Sanofi and Regeneron Launch Major New Immuno-Oncology Collaboration
(Thomson Reuters ONE) -
Sanofi and Regeneron Launch Major New Immuno-Oncology Collaboration
- Companies agree to jointly advance PD-1 and other new immuno-oncology
antibodies -
- Sanofi commits to an initial investment of up to $2.17 billion in the
exclusive collaboration, including $640 million in upfront payments to Regeneron
and a potential sales milestone of $375 million -
Paris and Tarrytown, New York - July 28, 2015 - Sanofi and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a new global
collaboration to discover, develop and commercialize new antibody cancer
treatments in the emerging field of immuno-oncology. As part of the agreement,
the two companies will jointly develop a programmed cell death protein 1 (PD-1)
inhibitor currently in Phase 1 testing, and plan to initiate clinical trials in
2016 with new therapeutic candidates based on ongoing, innovative preclinical
programs.
"The field of immuno-oncology has shown the potential to dramatically improve
outcomes for patients with certain types of cancer - however, the field is still
in its very early days," said George D. Yancopoulos, MD, PhD, Chief Scientific
Officer, Regeneron and President, Regeneron Laboratories. "We believe the
approaches most likely to deliver the best results to patients will combine
multiple innovative therapies acting on different pathways and targets both in
the tumor and the body's immune response - and precisely target these medicines
to the right patient. The efficiency and power of our suite of technologies,
such as VelocImmune(®) and VelociGene(®), combined with our human genetics
capabilities, uniquely positions the Alliance to accelerate the development of
potential new immuno-oncology treatment options for cancer patients."
Sanofi will make an upfront payment to Regeneron of $640 million and the
companies will invest $1 billion for discovery through proof of concept (POC)
development (usually a Phase 2a study) of monotherapy and novel combinations of
immuno-oncology antibody candidates to be funded 25 percent by Regeneron ($250
million) and 75 percent by Sanofi ($750 million). The companies have also
committed to equally fund an additional $650 million (or $325 million per
company) for development of REGN2810, a PD-1 inhibitor. In addition, Sanofi will
pay to Regeneron a one-time milestone of $375 million in the event that sales of
a PD-1 product and any other collaboration antibody sold for use in combination
with a PD-1 product exceed, in the aggregate, $2 billion in any consecutive 12-
month period. Finally, the two companies have agreed to re-allocate $75 million
(over three years) for immuno-oncology antibodies from Sanofi's $160 million
annual contribution to their existing antibody collaboration, which otherwise
continues as announced in November 2009. Beyond the committed funding,
additional funding will be allocated as programs enter post-POC development.
"The Sanofi-Regeneron Alliance has demonstrated its ability to translate
cutting-edge science into groundbreaking medicines for patients with serious
needs," said Elias Zerhouni, MD, President, Global R&D, Sanofi. "With more than
eight years of successful collaboration between us, I am confident in our
ability to advance these novel programs. In addition to PD-1, the collaboration
brings together a range of validated, innovative preclinical programs that have
unique potential to help patients either as monotherapy or in combination
approaches."
The new agreement covers both monoclonal antibodies and new bi-specific
antibodies, a variation of standard antibody therapeutics, in which two distinct
targets within the body can be bound by the same molecule, usually the cancer
cell and an immune cell. Regeneron has developed a novel and flexible
manufacturing platform that enables efficient production of bi-specific
antibodies that are otherwise similar to natural antibodies. Beyond PD-1, other
targets in preclinical development include antibodies to lymphocyte-activation
gene 3 (LAG3) and glucocorticoid-induced tumor-necrosis-factor-receptor-related
protein (GITR) and a programmed death-ligand 1 (PD-L1) inhibitor. Finally, the
collaboration is advancing bi-specific antibodies that target hematologic and
solid cancers, either as mono therapies or in combination regimens with other
immune modulating treatments.
Additional Information on the new immuno-oncology collaboration
* Regeneron will be responsible for discovery, antibody generation and
development through POC, at which time Sanofi will have the ability to opt-
in to further development and commercialization. In the existing antibody
collaboration, Sanofi has the opportunity to opt-in at the time of an
Investigational New Drug application (IND).
* The companies will alternate serving as the lead development and
commercialization organization after Sanofi opts-in to an antibody program.
* For programs where Regeneron is the lead, including REGN2810, Regeneron will
serve as the U.S. commercial lead, including recording U.S. sales and the
companies will equally fund post-POC development Sanofi will record sales
and serve as the commercial lead for all countries outside the U.S. Sanofi
will retain the right to co-promote in the U.S. and Regeneron will retain
the right to co-promote outside the U.S.
* For programs where Sanofi is the lead, Sanofi will serve as the U.S.
commercial lead and fund 100 percent of post-POC development, with Regeneron
reimbursing up to 50% percent of such costs through the IO collaboration
development balance, which represents the amount of development funding that
Regeneron is obligated to repay out of its share of profits as described
below. Sanofi will record sales and serve as the commercial lead for all
countries outside the U.S. Regeneron will retain the right to co-promote in
the U.S. and outside the U.S.
* Sanofi and Regeneron will share equally in worldwide profits from sale of
collaboration immuno-oncology antibodies.
* As in the existing antibody agreement, Regeneron will repay the immuno-
oncology collaboration development balance from its share of overall profits
of the immuno-oncology antibodies, in an annual amount equal to 10 percent
of the Regeneron share of profits.
The exclusive collaboration to discover and develop potential monotherapy or
novel combination immuno-oncology antibody candidates through POC will last five
years with an ability to extend the collaboration for selected ongoing programs
for an additional three years. The agreement does not include Chimeric Antigen
Receptors. Additional terms, including potential therapeutic targets or
mechanisms, were not disclosed.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi has core strengths in
the field of healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets, animal health
and the new 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 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 oncology, rheumatoid arthritis,
asthma, and atopic dermatitis. For additional information about the company,
please visit www.regeneron.com.
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
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"), 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 REGN2810 and antibodies
targeting programmed death-ligand 1 (PD-1), lymphocyte-activation gene 3 (LAG3),
and glucocorticoid-induced tumour-necrosis-factor-receptor-related protein
(GITR), as well as other monoclonal antibodies and bi-specific antibodies that
may be subject to the immuno-oncology collaboration with Sanofi described in
this news release; the potential for any license or collaboration agreement,
including Regeneron's agreements with Sanofi (such as the immuno-oncology
collaboration described in this news release) and Bayer HealthCare LLC, to be
cancelled or terminated without any further product success; unforeseen safety
issues resulting from the administration of products and product candidates in
patients, including serious complications or side effects in connection with the
use of Regeneron's product candidates in clinical trials; the likelihood and
timing of possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products, research and clinical programs, and
business, including those relating to patient privacy; 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; 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; 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 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 quarter
ended March 31, 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.
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(at)sanofi.com
Jack.Cox(at)sanofi.com
Contacts Regeneron:
Media Relations Investor Relations
Hala Mirza Manisha Narasimhan
Tel: +1 (914) 847-3422 Tel: +1 (914) 847-5126
Mobile: +1 (917) 929-1734 manisha.narasimhan(at)regeneron.com
hala.mirza(at)regeneron.com
Press release (PDF):
http://hugin.info/152918/R/1941594/701853.pdf
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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
[HUG#1941594]
Unternehmensinformation / Kurzprofil:
Datum: 28.07.2015 - 07:01 Uhr
Sprache: Deutsch
News-ID 409447
Anzahl Zeichen: 17256
contact information:
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