Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for
patients worldwide, announced today a long-term agreement with a
strategic partner to further enhance access to Adalimumab-ryvk in
the U.S. market, the newly U.S. Food and Drug Administration (FDA)
approved high-concentration interchangeable biosimilar to Humira.
“This new partnership agreement supports our financial guidance
and reflects Alvotech’s strong commitment to increasing patient
access to more affordable healthcare,” said Robert Wessman,
Chairman and CEO of Alvotech.
The current multi-product commercialization partnership between
Teva Pharmaceuticals and Alvotech remains unchanged and Teva will
continue to commercialize adalimumab-ryvk under the SIMLANDI® brand
in the U.S.
Use of TrademarksHumira® is a registered
trademark of AbbVie Biotechnology Ltd.
About AlvotechAlvotech 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.
Forward Looking StatementsCertain 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, the potential approval and commercial launch of
its product candidates, the timing of regulatory approval, and
market launches. 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
ability to raise substantial additional funding, which may not be
available on acceptable terms or at all; (2) the ability to
maintain stock exchange listing standards; (3) changes in
applicable laws or regulations; (4) the possibility that Alvotech
may be adversely affected by other economic, business, and/or
competitive factors; (5) Alvotech’s estimates of expenses and
profitability; (6) Alvotech’s ability to develop, manufacture and
commercialize the products and product candidates in its pipeline;
(7) actions of regulatory authorities, which may affect the
initiation, timing and progress of clinical studies or future
regulatory approvals or marketing authorizations; (8) the ability
of Alvotech or its partners to respond to inspection findings and
resolve deficiencies to the satisfaction of the regulators; (9) the
ability of Alvotech or its partners to enroll and retain patients
in clinical studies; (10) the ability of Alvotech or its partners
to gain approval from regulators for planned clinical studies,
study plans or sites; (11) the ability of Alvotech’s partners to
conduct, supervise and monitor existing and potential future
clinical studies, which may impact development timelines and plans;
(12) 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;
(13) the success of Alvotech’s current and future collaborations,
joint ventures, partnerships or licensing arrangements; (14)
Alvotech’s ability, and that of its commercial partners, to execute
their commercialization strategy for approved products; (15)
Alvotech’s ability to manufacture sufficient commercial supply of
its approved products; (16) the outcome of ongoing and future
litigation regarding Alvotech’s products and product candidates;
(17) the impact of worsening macroeconomic conditions, including
rising inflation and interest rates and general market conditions,
conflicts in Ukraine, the Middle East and other global geopolitical
tension, on the Company’s business, financial position, strategy
and anticipated milestones; and (18) 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.
ALVOTECH INVESTOR RELATIONS AND GLOBAL
COMMUNICATIONSBenedikt Stefansson, Senior
Directoralvotech.ir@alvotech.com
FOR MORE INFORMATIONPlease visit our investor
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Alvontech (NASDAQ:ALVO)
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