Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for
patients worldwide, announced today the initiation of a
pharmacokinetic study for AVT05, a biosimilar candidate to
Simponi® and Simponi Aria® (golimumab). The study will
assess the pharmacokinetics, safety, and tolerability of AVT05
compared to Simponi® in healthy adult subjects.
“We are delighted with the progress of the AVT05 development
program,” said Joseph McClellan, Chief Scientific Officer. “As we
enter our fifth biosimilar candidate into clinical studies, we
reaffirm our commitment to improving patient lives by expanding
access to affordable biologics.”
In the twelve months up to October 2022, combined net revenues
worldwide from sales of Simponi® and Simponi Aria® were over $2.2
billion, based on reported sales by the manufacturer of the
reference product [1].
Alvotech’s current portfolio of eight products and product
candidates target treating autoimmune disease, eye disorders,
osteoporosis, respiratory disease, and cancer. Alvotech’s first
marketed product, a biosimilar to Humira® (adalimumab), has been
launched in Europe and Canada, and approved in 35 countries
world-wide. Approval is pending in the United States.
About AVT05AVT05 is a biosimilar candidate for
Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal
antibody that inhibits tumor necrosis factor alpha (TNF alpha), a
cytokine protein in the body. Elevated TNF alpha levels have been
implicated in several chronic inflammatory diseases such as
rheumatoid arthritis, psoriatic arthritis, and ankylosing
spondylitis. AVT05 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.
[1] Source: Johnson & Johnson 10-Q and 10-K filings.
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 contains eight 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), 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 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, 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
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) the ability of Alvotech or its partners to respond to
inspection findings and resolve deficiencies to the satisfaction of
the regulators; (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 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 potential impact of the ongoing COVID-19 pandemic on the
FDA’s review timelines, including its ability to complete timely
inspection of manufacturing sites; (18) 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 (19) 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.
CONTACTSAlvotech Investor Relations and
Global CommunicationsBenedikt
Stefanssonalvotech.ir[at]alvotech.com
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