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Paris, France – November 10, 2009
Sanofi-aventis and Regeneron expand strategic antibody collaboration
- New agreements expand and extend November 2007 antibody collaboration.
- Collaboration goal is to advance 4 to 5 antibodies per year into
clinical development.
- Sanofi-aventis to fund up to $160M annually for Regeneron antibody
discovery research until end of 2017.
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals,
Inc. (Nasdaq: REGN) announced today that they have entered into agreements to
expand and extend their existing global collaboration to discover, develop,
and commercialize fully-human therapeutic monoclonal antibodies.
Sanofi-aventis will increase its annual funding commitment from $100M to $160
million beginning in 2010, and the research funding will now extend through
2017. The companies aim to advance an average of four to five antibodies into
clinical development each year. In addition to its VelocImmune technology,
Regeneron will contribute to the collaboration its next generation technologies
related to antibody generation.
Sanofi-aventis has an option to extend the discovery program for up to an additional
three years for further antibody development and preclinical activities. The
amendments announced today do not change the financial terms of the November
2007 agreement governing the development and commercialization of antibody drug
candidates arising from the discovery collaboration.
“The first two years of our collaboration with sanofi-aventis have been
extremely productive, with five VelocImmune® human antibodies in or entering
clinical development,” commented Leonard S. Schleifer, M.D., Ph.D., President
and Chief Executive Officer of Regeneron. “The expansion of our collaboration
provides even greater resources over a longer time horizon and will boost our
efforts to build a deep pipeline of new human antibody product candidates. Sanofi-aventis
is an ideal partner with the expertise and global reach to collaborate with
us on our mission to bring important new medicines to patients around the world.”
“This collaboration expansion demonstrates sanofi-aventis’ commitment to
become a key player in the field of monoclonal antibodies and our confidence
in our partner Regeneron,” declared Marc Cluzel, Executive Vice President,
R&D, sanofi-aventis. “It will further fuel our product pipeline and
will allow us bring multiple antibody product candidates into the clinic, thereby
significantly increasing the chance of providing patients access to innovative
drugs in various therapeutic areas.”
To date, Regeneron and sanofi-aventis have advanced four therapeutic antibodies
into clinical development and have filed an IND for a fifth additional antibody.
Among the four antibodies in clinical development, three are antibodies to (1)
the Interleukin-6 receptor (IL-6R), being developed for the treatment of rheumatoid
arthritis, (2) Nerve Growth Factor, being developed for the treatment of pain,
and (3) Delta-like Ligand 4 (Dll4), being developed for the treatment of advanced
malignancies. The targets of the two other antibodies have not been disclosed.
About the collaboration
The antibody collaboration entered into in November 2007 was scheduled to expire
at year-end 2012. As amended, the collaboration will continue at higher levels
of funding through 2017. As under the original terms, sanofi-aventis has the
exclusive option to co-develop with Regeneron each antibody drug candidate discovered
under the collaboration. Development costs for drug candidates co-developed
by the parties will be shared, with sanofi-aventis funding development costs
up front and Regeneron reimbursing half of the development costs for all collaboration
drug candidates from Regeneron’s share of future profits from commercialization
of collaboration products to the extent future profits are sufficient for this
purpose. In the United States, profits will be shared equally, while outside
the United States, profits will be split on a pre-determined sliding scale with
sanofi-aventis’ share ranging from 65 percent to 55 percent.
For any products successfully developed as part of the collaboration, sanofi-aventis
will take the lead in commercialization activities and will consolidate the
sales. Regeneron will have the right to co-promote any and all collaboration
products worldwide. In addition, Regeneron is entitled to receive up to a total
of $250 million of sales milestone payments when collaboration products achieve
certain aggregate annual ex-U.S. sales levels, starting at $1 billion.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, develops,
and commercializes medicines for the treatment of serious medical conditions.
In addition to ARCALYST(R) (rilonacept) Injection for Subcutaneous Use, its
first commercialized product, Regeneron has therapeutic candidates in clinical
trials for the potential treatment of cancer, eye diseases, inflammatory diseases,
and pain, and has preclinical programs in other diseases and disorders. Additional
information about Regeneron and recent news releases are available on Regeneron's
web site at www.regeneron.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more
information, visit: www.sanofi-aventis.com.
Forward Looking Statements
Regeneron
This news release discusses historical information and includes forward-looking
statements about Regeneron and its products, programs, finances, and business,
all of which involve a number of risks and uncertainties, such as risks associated
with preclinical and clinical development of its drug candidates, determinations
by regulatory and administrative governmental authorities which may delay or
restrict the ability to continue to develop or commercialize its drug candidates,
competing drugs that are superior to its product candidates, unanticipated expenses,
the availability and cost of capital, the costs of developing, producing, and
selling products, the potential for any collaboration agreement, including its
agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled
or to terminate without any product success, risks associated with third party
intellectual property, and other material risks. 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 (SEC), including its Form 10-Q
for the quarter ended September 30, 2009. Regeneron does not undertake any obligation
to update publicly any forward-looking statement, whether as a result of new
information, future events, or otherwise unless required by law.
Sanofi-aventis
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 product
development, product potential projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and expectations
with respect to future events, operations, products and services, 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-aventis’ 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-aventis, 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 EMEA, 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 products candidates, the absence of guarantee that the products
candidates if approved will be commercially successful, the future approval
and commercial success of therapeutic alternatives as well as those discussed
or identified in the public filings with the SEC and the AMF made by sanofi-aventis,
including those listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for
the year ended December 31, 2008. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise any forward-looking
information or statements.
