Sanofi and Regeneron Restructure Immuno-Oncology
Collaboration for Discovery and Development Programs
- Companies select two clinical-stage bispecific antibodies for
ongoing collaboration
- Sanofi able to independently pursue own immuno-oncology
programs; Regeneron retains full rights to all its other
investigational immuno-oncology programs
PARIS and TARRYTOWN, NY - January 7, 2019
- Sanofi (EURONEXT: SAN, NASDAQ: SNY) and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) have restructured their global
Immuno-oncology Discovery and Development Agreement for new
immuno-oncology cancer treatments. The 2015 Agreement was scheduled
to end in approximately mid-2020, and this revision provides for
ongoing collaborative development of two clinical-stage bispecific
antibody programs. This provides Sanofi increased flexibility to
advance its early-stage immuno-oncology pipeline independently
while Regeneron retains all rights to its other immuno-oncology
discovery and development programs. Under the terms of the
restructured Agreement:
- Sanofi will pay Regeneron $462 million representing the balance
of payments due under the original Immuno-oncology Agreement, which
covers the Sanofi share of the immuno-oncology discovery program
costs for the last quarter of 2018 and up to $120 million in
development costs for the two selected clinical-stage bispecific
antibodies, plus the termination fee for the other programs under
the original immuno-oncology agreement.
- Sanofi secures the right to opt-in to the BCMAxCD3 and
MUC16xCD3 bispecific programs when proof of concept is achieved or
when the allocated funding is expended.
- Regeneron will commit up to $70 million to further develop the
BCMAxCD3 bispecific antibody for multiple myeloma and up to $50
million to further develop the MUC16xCD3 bispecific for mucin-16
expressing cancers.
- Post opt-in, Sanofi will lead development and commercialization
of the BCMAxCD3 bispecific and fund 100 percent of development
costs, with Regeneron reimbursing up to 50 percent out of its share
of collaboration profits. Sanofi and Regeneron will share global
profits equally.
- Post-opt-in, Regeneron will lead MUC16xCD3 bispecific
development and lead commercialization in the U.S. The companies
will share development costs and global profits equally. Sanofi
will lead commercialization outside the U.S.
- The companies' ongoing collaboration for the development and
commercialization of Libtayo® (cemiplimab-rwlc), a PD1 antibody, is
unaffected by the amended Discovery and Development Agreement.
- Regeneron retains full rights to its other immuno-oncology
programs.
Under the Immuno-Oncology License and
Collaboration Agreement, the companies have developed and received
U.S. Food and Drug Administration approval of Libtayo for advanced
cutaneous squamous cell carcinoma (CSCC). A regulatory
application for Libtayo has also been submitted in the EU. An
ongoing joint clinical program is investigating Libtayo in multiple
other cancers, and includes potentially pivotal trials in lung,
cervical and skin cancers. Libtayo's safety and efficacy has not
been fully evaluated by any regulatory authority for indications
beyond advanced CSCC.
About RegeneronRegeneron (NASDAQ: REGN)
is a leading biotechnology company that invents life-transforming
medicines for people with serious diseases. Founded and led for 30
years by physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, neuromuscular diseases,
infectious diseases and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune® which produces
optimized fully-human antibodies, and ambitious research
initiatives such as the Regeneron Genetics Center, which is
conducting 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.
About Sanofi Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions. With more than 100,000 people in
100 countries, Sanofi is transforming scientific innovation into
healthcare solutions around the globe. Sanofi, Empowering Life
|
Media Relations Contact Ashleigh Koss Tel.: +1 (908)
981-8745 Ashleigh.Koss@sanofi.com Regeneron Media Relations
ContactHala MirzaTel: +1 (914) 847-3422hala.mirza@regeneron.com
|
Investor Relations
Contact George Grofik Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com
Regeneron Investor Relations ContactMark HudsonTel: +1 (914)
847-3482mark.hudson@regeneron.com |
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