- Teva and Alvotech bring together highly complementary
capabilities to secure a leading position in the U.S. biosimilar
market
- The collaboration is one of the broadest partnerships within
the U.S. biosimilar industry to date to accelerate improved patient
access for high quality biosimilar medicines in the U.S. biosimilar
industry
Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) and
biopharmaceutical company Alvotech today announced that they have
entered into an exclusive strategic partnership for the
commercialization in the U.S. of five biosimilar product
candidates. This strategic partnership combines Teva’s
long-standing commercial presence and extensive infrastructure in
the U.S. market with Alvotech’s scientific experience and
state-of-the-art biologics manufacturing. The initial pipeline
contains biosimilar candidates addressing multiple therapeutic
areas.
Robert Wessman, Alvotech’s founder and Chairman said, “We are
very proud to announce our strategic alliance with Teva – a leading
global pharmaceutical company, to accelerate the introduction and
adoption of new biosimilar medicines for patients in the U.S.
market. This is not only a big moment for the biosimilar industry
but also a very special moment for Alvotech, as we continue to join
forces with leading global and regional partners around the
world.“
“This commercial partnership with Alvotech will enable Teva to
lend its technical expertise in working with the FDA to bring
products to the U.S. market while broadening its growing biosimilar
portfolio and continuing to leverage its unique cross-functional
expertise across both specialty and generic medicines,” said
Brendan O’Grady, Executive Vice President and Head of North America
Commercial at Teva. “This collaboration is another step in our
unwavering commitment to develop and enable access to quality
medications to help improve the lives of patients."
Under this partnership agreement, Alvotech will be responsible
for the development, registration and supply of the biosimilars,
while Teva will be exclusively commercializing the products in the
U.S. The originator products of these five candidates currently
generate around $35 billion in U.S. sales. The agreement includes
an upfront payment, with subsequent milestone payments over the
next several years. Teva and Alvotech will share profit from the
commercialization of the biosimilars. All other financial terms and
product details remain confidential.
About Alvotech
Alvotech is a global biopharmaceutical company focused on the
development and manufacture of high quality biosimilars for global
markets. We are specialists in biotechnology, seeking to be a
global leader in the biosimilar space by delivering high quality,
cost-competitive products and services to our partners and to
patients worldwide. Our fully integrated approach, with
high-quality in-house competencies throughout the value chain,
enables the accelerated development of biosimilar medicines.
Alvotech‘s initial pipeline contains several monoclonal-antibody
and fusion-protein biosimilar candidates aimed at treating
autoimmunity, oncology, ophthalmology and inflammatory conditions
to improve quality of life for patients around the world. For more
information, please visit our website, www.alvotech.com or follow
us on LinkedIn, Twitter and Facebook.
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
specialty 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 specialty and biopharmaceutical
products. Learn more at http://www.tevapharm.com.
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
regarding the strategic partnership with Alvotech for the
commercialization in the U.S. of biosimilar product candidates,
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. Important factors that could
cause or contribute to such differences include risks relating
to:
the potential that the expected benefits and opportunities
related to our collaboration with Alvotech may not be realized or
may take longer to realize than expected;
challenges inherent in product research and development,
including uncertainty of clinical success and obtaining regulatory
approvals for the biosimilar product candidates;
the commercial success of the biosimilar product candidates, if
approved;
our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations and the effectiveness of our
patents and other measures to protect our intellectual property
rights;
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: duration, and
geographic reach of the COVID-19 pandemic and its impact on our
business, financial condition, operations, cash flows, and
liquidity and on the economy in general; interruptions in our
supply chain, including due to potential effects of the COVID-19
pandemic on our operations and business in geographic locations
impacted by the pandemic and on the business operations of our
customers and suppliers; adequacy of and our ability to
successfully execute and maintain the activities and efforts
related to the measures we have taken or may take in response to
the COVID-19 pandemic and associated costs therewith;
implementation of our restructuring plan announced in December
2017; challenges associated with conducting business globally,
including adverse effects of the COVID-19 pandemic, political or
economic instability, major hostilities or terrorism; our ability
to attract, hire and retain highly skilled personnel; our ability
to develop and commercialize additional pharmaceutical products;
compliance with anti-corruption sanctions and trade control laws;
manufacturing or quality control problems; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; significant sales to a
limited number of customers; our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject or delays in
governmental processing time including due to modified government
operations due to the COVID-19 pandemic and effects on product and
patent approvals; the effects of reforms in healthcare regulation
and reductions in pharmaceutical pricing, reimbursement and
coverage; governmental investigations into S&M practices;
potential liability for patent infringement; product liability
claims; increased government scrutiny of our patent settlement
agreements; failure to comply with complex Medicare and Medicaid
reporting and payment obligations; and environmental risks;
other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in Form 10-K for the year ended
December 31, 2019, and subsequent quarterly reports on Form 10-Q,
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200805005390/en/
Media: Alvotech Halldor Kristmannsson
Halldor.kristmannsson@alvotech.com Tel: +354 522-2900
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