Regulatory News:
Sanofi and Orano Med, a subsidiary of the Orano Group and a
pioneer in the development of targeted alphatherapies in oncology,
have entered into an agreement to combine their expertise in the
fight against rare cancers and further accelerate the development
of next-generation radioligand medicines.
Building on the expertise and radioligand pipeline of Orano Med,
Sanofi and Orano will invest in a new entity, operating under the
Orano Med brand, and focusing on the discovery, design, and
clinical development of next-generation radioligand therapies
(RLTs) based on lead-212 (212Pb) alpha-emitting isotopes. This
agreement follows Sanofi’s announcement of an exclusive licensing
agreement with Orano Med and RadioMedix to advance RLTs in rare
cancers with a focus on one late-stage project, AlphaMedix™.
Targeted alpha therapy relies on a simple concept: combining the
ability of biological vectors to target cancer cells with the
short-range and highly energetic cell-killing capabilities of
alpha-emitting radioisotopes. The vector directs the radioisotope
to the target cancer cells expressing the specific marker, even
when they have spread throughout the body. This unique mechanism of
action aims to damage or destroy target cancer cells, while
limiting impact on nearby healthy cells. This novel precision
medicine approach aims at changing the standard of care in some
rare cancers to extend patients’ lives and improve their quality of
life.
Paul Hudson CEO, Sanofi “We are
excited to partner with Orano in establishing a French pioneer that
unites our respective expertise in biopharma and nuclear technology
to drive groundbreaking progress in the fight against cancer. As a
French biopharmaceutical company, we are deeply committed to
fostering and enabling innovation in our home country. This
collaboration is part of a broader effort to strengthen our ties
within the scientific community, both in France and globally, with
the goal of advancing the development of cutting-edge treatments
for patients.”
Nicolas Maes CEO, Orano Group “The
success of Orano Med is an example of our group's ability to
diversify beyond our core nuclear business. By applying our
expertise in nuclear materials to fields like targeted alpha
therapies, we are demonstrating that nuclear technology can have a
positive societal impact, not just for energy and climate, but also
for human health. This innovation reflects Orano's commitment to
exploring new opportunities and taking bold steps to address some
of the world’s most pressing challenges.”
Sanofi’s investment will further strengthen Orano Med and allow
the company to accelerate the development of its pipeline,
leveraging its unique capabilities in the discovery and development
of lead-212 based therapies. Orano Med has also developed a highly
differentiating global industrial platform, which, thanks to its
vast stock of raw materials and patented manufacturing process,
will ensure an independent, reliable, and scalable supply of
lead-212 based therapies to patients worldwide.
Houman Ashrafian Executive Vice
President, Head of Research and Development, Sanofi “We are
thrilled to invest in the promising field of radioligand therapies,
a modality that holds potential for patients suffering from rare
cancers. We see opportunity in the innovative lead-212 based
technologies being developed by Orano Med, which align with our
commitment to advancing transformative therapies for unmet medical
needs.”
Julien Dodet President of the
Governing Board, Orano Med “Sanofi’s partnership with Orano Med is
a strong recognition of the potential of lead-212 based radioligand
therapies to advance the treatment of cancers. This validates our
strategy, having developed this expertise over the past 15 years,
and reinforces our position as a leader in targeted alpha
therapies. We look forward to combining Sanofi’s expertise with our
R&D and world-class radiopharmaceutical capabilities to advance
the development of potentially transformative therapies like
AlphaMedix and make them available to patients in need as quickly
as possible.”
In striving to become a leading immunoscience company globally,
Sanofi remains committed to advancing oncology innovation. The
pipeline is being reshaped and prioritized, leveraging expertise in
immunoscience to drive progress. Efforts are centered on
difficult-to-treat cancers such as select hematologic malignancies
and solid tumors with critical unmet needs, including rare cancers
such as multiple myeloma, acute myeloid leukemia, and certain types
of lymphomas, as well as gastrointestinal and lung cancers.
Sanofi and Orano Med are members of the Paris Saclay Cancer
Cluster and look forward to contributing to the ambitious agenda of
the France 2030 plan to accelerate innovation in oncology.
This agreement is subject to standard regulatory approvals
required for transactions of this nature.
Financial considerations
Under the terms of the agreement, Sanofi will make an equity
investment of €300 million, approximately 16% equity stake in the
new entity valued at €1.9bn.
About Sanofi
We are an innovative global healthcare company, driven by one
purpose: we chase the miracles of science to improve people’s
lives. Our team, across the world, is dedicated to transforming the
practice of medicine by working to turn the impossible into the
possible. We provide potentially life-changing treatment options
and life-saving vaccine protection to millions of people globally,
while putting sustainability and social responsibility at the
center of our ambitions. Sanofi is listed on EURONEXT: SAN and
NASDAQ: SNY
About Orano Med
Orano Med, a subsidiary of the Orano Group, is a clinical-stage
biotechnology company that develops a new generation of targeted
therapies against cancer using the unique properties of lead-212
(212Pb), an alpha-emitting radioisotope and one of the more potent
therapeutic payloads against cancer cells known as Targeted
Alpha-Emitter Therapy (TAT). The company is developing several
treatments using 212Pb combined with various targeting agents.
Orano Med has 212Pb manufacturing facilities, laboratories, and
R&D centers in France and in the US and is currently investing
to further expand its GMP-manufacturing capacities for 212Pb
radiolabeled pharmaceuticals in North America and Europe.
As a recognized international operator in the field of nuclear
materials, Orano Group delivers solutions to address present and
future global energy and health challenges. Its expertise and
mastery of cutting-edge technologies enable Orano to offer its
customers high value-added products and services throughout the
entire fuel cycle. Every day, the Orano group’s 17,500 employees
draw on their skills, unwavering dedication to safety and constant
quest for innovation, with the commitment to develop know-how in
the transformation and control of nuclear materials, for the
climate and for a healthy and resource-efficient world, now and
tomorrow.
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 fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that pandemics or other
global crises may have on us, our customers, suppliers, vendors,
and other business partners, and the financial condition of any one
of them, as well as on our employees and on the global economy as a
whole. The risks and uncertainties also include the uncertainties
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,
2023. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
All trademarks mentioned in this press release are the property
of the Sanofi group apart from AlphaMedix.
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version on businesswire.com: https://www.businesswire.com/news/home/20241016458571/en/
Orano Med Sophie Letournel | +33 6 38 44 34 11 |
sophie.letournel@orano.group
Orano Group Press Office | +33 (0)1 34 96 12 15 |
press@orano.group
Orano Investor relations Marc Quesnoy |
investors@orano.group
Sanofi Media Relations Sandrine Guendoul | + 33 6 25 09
14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215
432 0234 | evan.berland@sanofi.com Nicolas Obrist | + 33 6
77 21 27 55 | nicolas.obrist@sanofi.com Victor Rouault | +
33 6 70 93 71 40 | victor.rouault@sanofi.com Timothy Gilbert
| + 1 516 521 2929 | timothy.gilbert@sanofi.com
Sanofi Investor Relations Thomas Kudsk Larsen |+ 44 7545
513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | + 33 6
47 04 12 11 | alize.kaisserian@sanofi.com
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