Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a global
leader in generic and innovative medicines and Alvotech (NASDAQ:
ALVO), a global biotech company specializing in the development and
manufacture of biosimilar medicines for patients worldwide, today
announced that they have agreed to expand their existing strategic
partnership agreement. Teva will also acquire subordinated
convertible bonds to be issued by Alvotech.
The partners continue working closely on matters concerning
pending approval in the U.S. for AVT02, an interchangeable
high-concentration biosimilar candidate for Humira® (adalimumab).
The existing strategic partnership agreement also includes four
other biosimilar candidates, one of which is AVT04, a proposed
biosimilar for Stelara® (ustekinumab), which is currently pending
U.S. Food and Drug Administration (FDA) approval.
The expansion to the existing strategic partnership agreement
pertains to exclusive commercialization in the U.S. by Teva of two
new biosimilar candidates and line extensions of two current
biosimilar candidates in the partnership, to be developed, and
manufactured by Alvotech. The agreement includes milestone
payments, the majority paid following product approvals and upon
achieving significant sales milestones. Teva and Alvotech will
share profit from the commercialization of the biosimilars. All
other financial terms and product details remain confidential.
The agreement also includes increased involvement by Teva
regarding manufacturing and quality at Alvotech’s manufacturing
facility. Teva is actively supporting Alvotech on-site in Iceland
to be fully ready for an FDA inspection.
Teva has agreed to acquire subordinated convertible bonds to be
issued by Alvotech pursuant to a convertible bond instrument, dated
December 20, 2022, for $40 million. Teva’s investment will be used
by Alvotech as part of the funding for continued development of its
biosimilars pipeline over the near-term.
“We welcome Teva’s continued partnership and this expansion of
our partnership agreement,” said Robert Wessman, Chairman and CEO
of Alvotech. “We remain focused on preparing for a successful
pre-approval inspection and resolving any outstanding issues
identified by the FDA to be able to bring our biosimilar candidates
to patients in the U.S. with Teva as soon as possible.”
“Teva remains fully committed to its leadership in biosimilars
and the partnership with Alvotech,” said Sven Dethlefs, Executive
Vice President, North America Commercial. “We remain optimistic
about additional compounds in the pipeline and continued progress
with AVT02 and ATV04.”
About AVT02 AVT02 is a monoclonal antibody and has been
approved as a biosimilar to Humira® (adalimumab) in several
countries globally, including the 27 member states of the European
Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada,
Australia, and Saudi Arabia. It is currently marketed in multiple
European countries and in Canada. Dossiers are also under review in
multiple countries globally.
About AVT04 (ustekinumab) AVT04 is a monoclonal antibody
and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab
binds to two cytokines, IL-12 and IL-23, that are involved in
inflammatory and immune responses [1]. AVT04 is an investigational
product and has not received regulatory approval in any country.
Biosimilarity has not been established by regulatory authorities
and is not claimed. Stelara is a registered trademark of Johnson
& Johnson. [1]
https://www.janssenlabels.com/package-insert/product-monograph/prescribinginformation/STELARA-pi.pdf
No Offer This communication is not a public offer of
securities for sale in the United States. This communication is for
informational purposes only and does not constitute an offer to
sell or a solicitation of an offer to buy any securities in the
United States or elsewhere, nor shall there be any sale of any such
securities in any state or jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of such state or
jurisdiction.
About Alvotech Alvotech is a biotech company, founded by
Robert Wessman, focused solely on the development and manufacture
of biosimilar medicines for patients worldwide. Alvotech seeks to
be a global leader in the biosimilar space by delivering high
quality, cost-effective products, and services, enabled by a fully
integrated approach and broad in-house capabilities. Alvotech’s
current pipeline includes eight disclosed biosimilar candidates
aimed at treating autoimmune disorders, eye disorders,
osteoporosis, respiratory disease, and cancer. Alvotech has formed
a network of strategic commercial partnerships to provide global
reach and leverage local expertise in markets that include the
United States, Europe, Japan, China, and other Asian countries and
large parts of South America, Africa and the Middle East.
Alvotech’s commercial partners include Teva Pharmaceuticals, a US
affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA
Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma
(EEA, UK, Switzerland, Canada, Australia and New Zealand),
Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South
Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River
Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong,
Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and
Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi
Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs,
Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co.,
Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each
commercial partnership covers a unique set of product(s) and
territories. Except as specifically set forth therein, Alvotech
disclaims responsibility for the content of periodic filings,
disclosures and other reports made available by its partners. For
more information, please visit www.alvotech.com. None of the
information on the Alvotech website shall be deemed part of this
press release.
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 medicines and
biopharmaceutical products. Learn more at www.tevapharm.com.
Forward Looking Statements (Alvotech) Certain statements
in this communication may be considered “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements
generally relate to future events or the future financial operating
performance of Alvotech and may include, for example, Alvotech’s
expectations regarding competitive advantages, business prospects
and opportunities including pipeline product development, future
plans and intentions, results, level of activities, performance,
goals or achievements or other future events, regulatory
submissions, review and interactions, including the resubmission of
a BLA for AVT02 and a potential reinspection of Alvotech’s
manufacturing facility, the satisfactory responses to the FDA’s
inspection findings and resolution of other deficiencies conveyed
following the inspection of Alvotech’s manufacturing site, the
potential approval and commercial launch of its product candidates,
the timing of regulatory approval, including for AVT04, and market
launches, the estimated size of the total addressable market of
Alvotech’s pipeline products, the availability of financing
options, including the size, timeline, securities, terms and
conditions of, and use of proceeds from, a potential financing. In
some cases, you can identify forward-looking statements by
terminology such as “may”, “should”, “expect”, “intend”, “will”,
“estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim”
or “continue”, or the negatives of these terms or variations of
them or similar terminology. Such forward-looking statements are
subject to risks, uncertainties, and other factors which could
cause actual results to differ materially from those expressed or
implied by such forward-looking statements. These forward-looking
statements are based upon estimates and assumptions that, while
considered reasonable by Alvotech and its management, are
inherently uncertain and are inherently subject to risks,
variability, and contingencies, many of which are beyond Alvotech’s
control. Factors that may cause actual results to differ materially
from current expectations include, but are not limited to: (1) the
outcome of any legal proceedings that may be instituted against
Alvotech or others following the business combination between
Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech;
(2) the ability to raise substantial additional funding, which may
not be available on acceptable terms or at all; (3) the ability to
maintain stock exchange listing standards; (4) changes in
applicable laws or regulations; (5) the possibility that Alvotech
may be adversely affected by other economic, business, and/or
competitive factors; (6) Alvotech’s estimates of expenses and
profitability; (7) Alvotech’s ability to develop, manufacture and
commercialize the products and product candidates in its pipeline;
(8) actions of regulatory authorities, which may affect the
initiation, timing and progress of clinical studies or future
regulatory approvals or marketing authorizations; (9) the ability
of Alvotech or its partners to respond to inspection findings and
resolve deficiencies to the satisfaction of the regulators; (10)
the ability of Alvotech or its partners to enroll and retain
patients in clinical studies; (11) the ability of Alvotech or its
partners to gain approval from regulators for planned clinical
studies, study plans or sites; (12) the ability of Alvotech’s
partners to conduct, supervise and monitor existing and potential
future clinical studies, which may impact development timelines and
plans; (13) Alvotech’s ability to obtain and maintain regulatory
approval or authorizations of its products, including the timing or
likelihood of expansion into additional markets or geographies;
(14) the success of Alvotech’s current and future collaborations,
joint ventures, partnerships or licensing arrangements; (15)
Alvotech’s ability, and that of its commercial partners, to execute
their commercialization strategy for approved products; (16)
Alvotech’s ability to manufacture sufficient commercial supply of
its approved products; (17) the outcome of ongoing and future
litigation regarding Alvotech’s products and product candidates;
(18) the potential impact of the ongoing COVID-19 pandemic on the
FDA’s review timelines, including its ability to complete timely
inspection of manufacturing sites; (19) the impact of worsening
macroeconomic conditions, including rising inflation and interest
rates and general market conditions, war in Ukraine and global
geopolitical tension, and the ongoing and evolving COVID-19
pandemic on the Company’s business, financial position, strategy
and anticipated milestones; and (20) other risks and uncertainties
set forth in the sections entitled “Risk Factors” and “Cautionary
Note Regarding Forward-Looking Statements” in documents that
Alvotech may from time to time file or furnish with the SEC. There
may be additional risks that Alvotech does not presently know or
that Alvotech currently believes are immaterial that could also
cause actual results to differ from those contained in the
forward-looking statements. Nothing in this communication should be
regarded as a representation by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved. You should not place undue reliance on forward-looking
statements, which speak only as of the date they are made. Alvotech
does not undertake any duty to update these forward-looking
statements or to inform the recipient of any matters of which any
of them becomes aware of which may affect any matter referred to in
this communication. Alvotech disclaims any and all liability for
any loss or damage (whether foreseeable or not) suffered or
incurred by any person or entity as a result of anything contained
or omitted from this communication and such liability is expressly
disclaimed. The recipient agrees that it shall not seek to sue or
otherwise hold Alvotech or any of its directors, officers,
employees, affiliates, agents, advisors, or representatives liable
in any respect for the provision of this communication, the
information contained in this communication, or the omission of any
information from this communication.
Forward Looking Statements (Teva) 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
the expansion of our strategic partnership with Alvotech and the
ability to achieve expected results from investments in biosimilar
candidates including to obtain U.S. regulatory approval for AVT02
the proposed biosimilar to Humira® and AVT04, the proposed
biosimilar to Stelara® (ustekinumab), as well as from the
investment in Alvotech’s subordinated convertible bonds; 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 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 first 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/20230724198201/en/
Alvotech Investor Relations
Benedikt Stefansson alvotech.ir@alvotech.com
Teva Investor Relations Ran
Meir Ran.Meir@tevapharm.com
Yael Ashman Yael.Ashman@teva.co.il
Sanjeev Sharma Sanjeev.Sharma01@tevapharm.com
Teva PR Contacts Kelley
Dougherty Kelley.Dougherty@tevapharm.com
Doris Yiu Doris.Yiu@tevapharm.com
Yonatan Beker Yonatan.Beker@tevapharm.com
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