TARRYTOWN, N.Y. and
PARIS, July
28, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi 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, M.D., Ph.D.,
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 will 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 Sanofi-Regeneron 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 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, M.D., 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 programs in preclinical development include antibodies
to lymphocyte-activation gene 3 (LAG3), glucocorticoid-induced
tumor-necrosis-factor-receptor-related protein (GITR) and a
programmed death ligand (PD-L1) inhibitor. Finally, the
collaboration is advancing bi-specific antibodies that target
hematologic and solid cancers, either as monotherapies or in
combination regimens with other immune modulating treatments.
"Despite many advances over the last decades, cancer remains a
leading cause of death and suffering around the world," said
Israel Lowy, M.D., Ph.D., Vice
President Clinical Sciences, Head of Translational Science and
Oncology, Regeneron. "Although initial advances with
immuno-oncology have helped certain patients, there is a
tremendous opportunity to further unlock the potential of
this new approach to help even greater numbers of people
living with cancer."
The framework of the new immuno-oncology collaboration is as
follows:
- 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, not extended, or otherwise 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
Jack
Cox
Tel: +33 (0) 1 53 77
94 74
Mobile: +33 (0) 6 78
52 05 36
Jack.Cox@sanofi.com
|
Investor
Relations
Sébastien
Martel
Tel: +33 (0)1 53 77
45 45
IR@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@regeneron.com
|
hala.mirza@regeneron.com
|
|
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SOURCE Regeneron Pharmaceuticals, Inc.