- TEV ‘574, a novel anti-TL1A therapy, is being developed to
treat ulcerative colitis and Crohn’s disease
- Collaboration supports Sanofi’s immunology strategy of
exploring novel mechanisms of action for chronic inflammatory
diseases
- Collaboration leverages the innovative R&D and commercial
expertise of both companies
Sanofi (EURONEXT: SAN and NASDAQ: SNY) and Teva Pharmaceuticals,
a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) announce today a collaboration to co-develop and
co-commercialize asset TEV ‘574, currently in Phase 2b clinical
trials for the treatment of Ulcerative Colitis and Crohn's Disease,
two types of inflammatory bowel disease.
Paul Hudson Chief Executive Officer, Sanofi “Anti-TL1As
are a promising class of therapies, and we believe that TEV ‘574
could emerge as a best-in-class option for people living with
serious gastrointestinal diseases. This collaboration strengthens
our commitment to advancing innovative treatment options for
inflammatory conditions with a high unmet need and bolsters our
goal to be an industry leader in immunology.”
Richard Francis President and Chief Executive Officer,
Teva “This is a new era for Teva, and our robust, innovative
pipeline is key to our Pivot to Growth strategy. This collaboration
further validates the great science that Teva has to offer with our
internally developed anti-TL1A. We are honored to partner with
Sanofi to bring their proven capabilities, leadership, and success
in the immunology and gastroenterology space together with our
capabilities to optimize development and global launches.”
Under the terms of the new collaboration agreement, Teva will
receive an upfront payment of €469 million ($500 million) and up to
€940 million ($1 billion) in development and launch milestones.
Each company will equally share the development costs globally and
net profits and losses in major markets, with other markets subject
to a royalty arrangement and Sanofi will lead the development of
the Phase 3 program. Teva will lead commercialization of the
product in Europe, Israel and specified other countries, and Sanofi
will lead commercialization in North America, Japan, other parts of
Asia and the rest of the world. The transaction will become
effective after customary closing conditions are met. Initial
program results are expected to be available in 2024.
Inflammatory bowel disease (IBD) is the term for two conditions
-- Crohn’s disease and ulcerative colitis – characterized by
chronic inflammation of the gastrointestinal (GI) tract. Prolonged
inflammation results in damage to the GI tract. The common symptoms
for both conditions are persistent diarrhea, rectal bleeding,
abdominal pain, fatigue, and weight loss. An estimated ~10 million
people worldwide live with IBD.
Teva Investor Call
Teva will hold an investor call and live webcast today
(Wednesday, October 4, 2023) at 8:00 a.m. ET to discuss this
collaboration. To participate, please register in advance
here to obtain a local or toll-free phone number and your
personal pin. A live webcast of the call will be available on
Teva's website at:
https://ir.tevapharm.com/Events-and-Presentations.
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 some 100 countries, 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 Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
innovative medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of innovative and
biopharmaceutical products. Learn more at www.tevapharm.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 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,
2022. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
Teva Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include: risks relating to our exclusive collaboration
with Sanofi, including uncertainties around the effective date of
the collaboration and our ability to satisfy the closing conditions
related thereto; risks related to the timing of and our ability to
achieve expected results for TEV-48574 (anti-TL1A), including our
ability to commercialize TEV-48574 (anti-TL1A); the extent to which
we will realize the anticipated financial and other benefits of the
Sanofi collaboration; our ability to satisfy the conditions to
receiving milestone cash payments under the Sanofi collaboration
agreement; the risk that we will incur significant costs in
connection with the development of TEV-48574 (anti-TL1A), which may
exceed any revenue generated by TEV-48574 (anti-TL1A); risks that
regulatory approvals and other requirements may delay the
development and commercialization of TEV-48574 (anti-TL1A); our
ability to successfully compete in the marketplace, including our
ability to develop and commercialize biopharmaceutical products,
competition for our innovative medicines, including AUSTEDO®,
AJOVY® and COPAXONE®, our ability to achieve expected results from
investments in our product pipeline, our ability to develop and
commercialize additional pharmaceutical products, and the
effectiveness of our patents and other measures to protect our
intellectual property rights; our ability to successfully launch
and execute our new Pivot to Growth strategy, including to expand
our innovative and biosimilar medicines pipeline and profitably
commercialize the innovative medicines and biosimilar portfolio,
whether organically or through business development, and to sustain
and focus our portfolio of generics medicines; our substantial
indebtedness which may limit our ability to incur additional
indebtedness, engage in additional transactions or make new
investments, may result in a further downgrade of our credit
ratings; and our inability to raise debt or borrow funds in amounts
or on terms that are favorable to us; our business and operations
in general, including, the impact of global economic conditions and
other macroeconomic developments and the governmental and societal
responses thereto, and costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject;
compliance, regulatory and litigation matters, including failure to
comply with complex legal and regulatory environments; other
financial and economic risks; and other factors discussed in our
Quarterly Report on Form 10-Q for the second quarter of 2023 and in
our Annual Report on Form 10-K for the year ended December 31,
2022, including in the section captioned “Risk Factors.”
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20231003753257/en/
Sanofi Media Relations Sally Bain | + 1 617 834 6026 |
sally.bain@sanofi.com Sandrine Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.com Victor Rouault | + 33 6 70 93
71 40 | victor.rouault@sanofi.com
Sanofi Investor Relations Eva Schaefer-Jansen | + 33 7 86
80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine |
+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612
7239 | felix.lauscher@sanofi.com Tarik Elgoutni| + 1 617 710
3587 | tarik.elgoutni@sanofi.com Nathalie Pham | + 33 7 85
93 30 17 | nathalie.pham@sanofi.com
Teva Investor Relations Ran Meir | (267) 468-4475 Yael
Ashman | +972 (3) 914 8262 Sanjeev Sharma | (973)
524-1908
Teva Corporate Affairs Kelley Dougherty | (973) 658-0237
Eden Klein | +972 (3) 906 2645
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