- Royalty Pharma to provide R&D funding support of up to
$125 million for the development of olanzapine LAI (TEV-‘749), a
long-acting subcutaneous injectable olanzapine for
schizophrenia
- Phase 3 data expected in the second half of
2024
Teva Pharmaceuticals International GmbH, a subsidiary of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Royalty
Pharma plc (Nasdaq: RPRX), announced today a collaboration to
further accelerate the clinical research program for Teva’s
olanzapine LAI (TEV-‘749) by entering into a funding agreement of
up to $125 million to offset program costs. Olanzapine LAI
(TEV-‘749) is a once-monthly subcutaneous long-acting injection of
the atypical antipsychotic olanzapine that is currently in Phase 3
for the treatment of schizophrenia and has the potential to be the
first long-acting olanzapine with a favorable safety profile.
“Since launching Teva’s Pivot to Growth strategy in May 2023, we
have been working on novel and expedited ways to both continue to
invest in our robust innovative pipeline while supporting the
growth of our in-line businesses,” said Richard Francis, President
and CEO of Teva. “We are excited to collaborate with Royalty
Pharma, a leading funder of innovation with a strong track record,
experience, and reputation. This funding agreement enables us to
continue to accelerate the development of olanzapine LAI
(TEV-‘749), a critical program for us, without impacting resources
dedicated to our innovative and generic medicines.”
"We are delighted to partner with Teva, to realize the potential
of olanzapine LAI and support them as their innovative pipeline
continues to come to fruition,” said Pablo Legorreta, founder and
Chief Executive Officer of Royalty Pharma. “Long-acting injectable
antipsychotics improve compliance and can help prevent
hospitalizations. Teva’s olanzapine LAI could be an important new
treatment option for patients with schizophrenia.”
Transaction Terms Under the agreement, Royalty Pharma
will provide Teva up to $100 million to fund ongoing development
costs for olanzapine LAI (TEV-‘749), and Royalty Pharma and Teva
have a mutual option to increase the total funding amount to $125
million. Upon U.S. Food and Drug Administration (“FDA”) approval,
Teva will pay Royalty Pharma the total amount funded over five
years, as well as low to mid-single digit royalties upon
commercialization. If Teva chooses not to file a New Drug
Application with the FDA following positive Phase 3 study results,
then Teva will pay an amount equal to 125% of the total amount
funded. Teva will lead the development and commercialization of
olanzapine LAI (TEV-‘749) globally.
About olanzapine LAI (TEV-‘749) TEV-‘749 (olanzapine)
extended-release injectable suspension, for subcutaneous use rather
than intramuscular use, is the second product developed by Teva to
utilize SteadyTeq™, a copolymer technology proprietary to MedinCell
S.A. that allows for sustained release of olanzapine at a
therapeutic dose over the full one-month dosing interval. SteadyTeq
is also utilized in UZEDY™ (risperidone) extended-release
injectable suspension for subcutaneous use, which was approved by
the FDA for the treatment of schizophrenia in adults in April 2023.
In the third quarter of 2022, Teva progressed the development of
olanzapine LAI (TEV-‘749) to Phase 3, and Phase 3 data on
olanzapine LAI are now expected in the second half of 2024.
Teva leads the clinical development and regulatory process and
is responsible for commercialization of these products.
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 medicines research and
operations supporting our growing portfolio of innovative medicines
and biopharmaceutical products. Learn more at
www.tevapharm.com.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of
biopharmaceutical royalties and a leading funder of innovation
across the biopharmaceutical industry, collaborating with
innovators from academic institutions, research hospitals and
non-profits through small and mid-cap biotechnology companies to
leading global pharmaceutical companies. Royalty Pharma has
assembled a portfolio of royalties which entitles it to payments
based directly on the top-line sales of many of the industry’s
leading therapies. Royalty Pharma funds innovation in the
biopharmaceutical industry both directly and indirectly - directly
when it partners with companies to co-fund late-stage clinical
trials and new product launches in exchange for future royalties,
and indirectly when it acquires existing royalties from the
original innovators. Royalty Pharma’s current portfolio includes
royalties on more than 35 commercial products, including Vertex’s
Trikafta, Kalydeco, Orkambi and Symdeko, Biogen’s Tysabri, AbbVie
and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s
Xtandi, GSK’s Trelegy, Novartis’ Promacta, Pfizer’s Nurtec ODT,
Johnson & Johnson’s Tremfya, Roche’s Evrysdi, Gilead’s
Trodelvy, and 12 development-stage product candidates.
Teva Cautionary Note Regarding 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 ability to further
accelerate the development and achieve expected results for
olanzapine LAI (TEV-‘749), including our ability to commercialize
olanzapine LAI (TEV-‘749); our ability to pay milestone payments
under the funding agreement with Royalty Pharma; the risk that we
will incur significant costs in connection with the development of
olanzapine LAI (TEV-‘749), which may exceed any revenue generated
by olanzapine LAI (TEV-‘749); risks that regulatory approvals and
other requirements may delay the development and commercialization
of olanzapine LAI (TEV-‘749); 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; our
substantial indebtedness; our business and operations in general,
including: the impact of global economic conditions and other
macroeconomic developments and the governmental and societal
responses thereto; 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 this press release, in our quarterly report on Form
10-Q for the third quarter of 2023 and in our Annual Report on Form
10-K for the year ended December 31, 2022, including in the
sections captioned "Risk Factors” and “Forward Looking Statements.”
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.
Royalty Pharma Forward-Looking Statements
The information set forth herein does not purport to be complete
or to contain all of the information you may desire. Statements
contained herein are made as of the date of this document unless
stated otherwise, and neither the delivery of this document at any
time, nor any sale of securities, shall under any circumstances
create an implication that the information contained herein is
correct as of any time after such date or that information will be
updated or revised to reflect information that subsequently becomes
available or changes occurring after the date hereof.
This document contains statements that constitute
“forward-looking statements” as that term is defined in the United
States Private Securities Litigation Reform Act of 1995, including
statements that express the company’s opinions, expectations,
beliefs, plans, objectives, assumptions or projections regarding
future events or future results, in contrast with statements that
reflect historical facts. Examples include discussion of Royalty
Pharma’s strategies, financing plans, growth opportunities and
market growth. In some cases, you can identify such forward-looking
statements by terminology such as “anticipate,” “intend,”
“believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,”
“will,” “would,” “could” or “should,” the negative of these terms
or similar expressions. Forward-looking statements are based on
management’s current beliefs and assumptions and on information
currently available to the company. However, these forward-looking
statements are not a guarantee of Royalty Pharma’s performance, and
you should not place undue reliance on such statements.
Forward-looking statements are subject to many risks, uncertainties
and other variable circumstances, and other factors. Such risks and
uncertainties may cause the statements to be inaccurate and readers
are cautioned not to place undue reliance on such statements. Many
of these risks are outside of the company’s control and could cause
its actual results to differ materially from those it thought would
occur. The forward-looking statements included in this document are
made only as of the date hereof. The company does not undertake,
and specifically declines, any obligation to update any such
statements or to publicly announce the results of any revisions to
any such statements to reflect future events or developments,
except as required by law.
Certain information contained in this document relates to or is
based on studies, publications, surveys and other data obtained
from third-party sources and the company's own internal estimates
and research. While the company believes these third-party sources
to be reliable as of the date of this document, it has not
independently verified, and makes no representation as to the
adequacy, fairness, accuracy or completeness of, any information
obtained from third-party sources. In addition, all of the market
data included in this document involves a number of assumptions and
limitations, and there can be no guarantee as to the accuracy or
reliability of such assumptions. Finally, while the company
believes its own internal research is reliable, such research has
not been verified by any independent source.
For further information, please reference Royalty Pharma’s
reports and documents filed with the U.S. Securities and Exchange
Commission (SEC). You may get these documents by visiting EDGAR on
the SEC website at www.sec.gov.
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IR United States Ran Meir (267) 468-4475
Israel Yael Ashman 972 (3) 914-8262
PR United States Kelley Dougherty (973) 658-0237
Israel Eden Klein 972 (3) 906-2645
Royalty Pharma Investor Relations and Communications +1
(212) 883-6637 ir@royaltypharma.com
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