- According to the settlement agreement, AVT04 (ustekinumab) can
be marketed in the US, subject to regulatory approval, no later
than February 21, 2025
Alvotech (NASDAQ: ALVO), a global biotech company specializing
in the development and manufacture of biosimilar medicines for
patients worldwide, and Teva Pharmaceuticals, Inc., a U.S.
affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:
TEVA), today announced they have reached a settlement and license
agreement with Johnson & Johnson (NYSE:JNJ) concerning AVT04,
Alvotech’s proposed biosimilar to Stelara® (ustekinumab) in the
United States. The settlement grants a license entry date for AVT04
in the United States no later than February 21, 2025.
“We are delighted to have secured a U.S. license date for our
second biosimilar candidate in the U.S. and I believe this
exemplifies our multi-product approach to biosimilars globally,”
said Robert Wessman, Chairman and CEO of Alvotech.
“Biosimilars are a key component of Teva’s short and long-term
strategy,” said Sven Dethlefs, PhD, Executive Vice President, North
America Commercial at Teva, “Today’s announcement is another step
forward in our partnership with Alvotech, who shares our commitment
to lower the cost burden of biologics on the healthcare
system.”
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/prescribing-information/STELARA-pi.pdf
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 disease, 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 medicines 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 and
may include, for example, Alvotech’s expectations regarding
regulatory review and interactions, the timing and results of the
facility inspection by the FDA, satisfactory responses to the FDA’s
inspection findings and resolution of deficiencies conveyed
following the inspection of Alvotech’s manufacturing site, the
potential approval and commercial launch of its product candidates,
including for AVT02, AVT04 and other product candidates in scope of
the partnership with Teva, the timing of the announcement of
clinical study results, regulatory approvals and market launches,
the estimated size of the total addressable market of Alvotech’s
pipeline products, 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. 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) the ability of
Alvotech or its partners to respond to inspection findings and
resolve deficiencies to the satisfaction of the regulators; (9)
actions of regulatory authorities, which may affect the initiation,
timing and progress of clinical studies or future regulatory
approvals or marketing authorizations; (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.
Cautionary Note Regarding 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: our ability to develop and commercialize
AVT04, our proposed biosimilar to Stelara® (ustekinumab); 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; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230612976249/en/
Alvotech Investor Relations and Global Communications
Benedikt Stefansson alvotech.ir@alvotech.com
Teva Investor Relations Ran Meir
Ran.Meir@tevapharm.com
Yael Ashman Yael.Ashman@teva.co.il
Teva PR Contacts Doris Yiu Doris.Yiu@tevapharm.com
Yonatan Beker Yonatan.Beker@tevapharm.com
Alvontech (NASDAQ:ALVO)
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Alvontech (NASDAQ:ALVO)
過去 株価チャート
から 12 2023 まで 12 2024
