Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for
patients worldwide, announced today that the US Food and Drug
Administration (FDA) has issued a complete response letter (CRL)
for Alvotech’s Biologics License Application (BLA) for AVT04, a
biosimilar candidate to Stelara® (ustekinumab).
As expected, the CRL noted that certain deficiencies, which were
conveyed following the FDA’s inspection of the company’s Reykjavik
facility that concluded in March 2023, must be satisfactorily
resolved before the application can be approved. No other
deficiencies in the application were noted by the FDA. Alvotech
intends to resubmit the BLA for AVT04 to the FDA shortly, which
would likely trigger a six-month review period and a new Biosimilar
User Fee Act (BsUFA) goal date.
“AVT04 has recently been approved in Japan, and other marketing
applications for AVT04 are currently awaiting approval in other
major markets. Based on our latest interactions with the FDA we are
currently expecting that the agency will reinspect our facility in
the beginning of next year. We look forward to being able to bring
AVT04 to U.S. patients, pending a satisfactory inspection and BLA
approval, no later than in February 2025, in accordance with our
license entry date agreement,” said Robert Wessman, Chairman and
CEO of Alvotech.
In June 2023 Alvotech and Teva, the exclusive commercialization
partner for AVT04 in the U.S., reached a settlement and license
agreement with Johnson & Johnson, that grants an entry date for
AVT04 in the U.S. no later than February 21, 2025.
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 has been
approved in Japan. Dossiers are currently under evaluation in other
major markets globally.
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 its expected future business, financial performance, the
use of proceeds from the private placement, and the future
utilization of the Yorkville facility. 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) changes in
applicable laws or regulations; (3) the possibility that Alvotech
may be adversely affected by other economic, business, and/or
competitive factors; (4) Alvotech’s estimates of expenses and
profitability; (5) Alvotech’s ability to develop, manufacture and
commercialize the products and product candidates in its pipeline;
(6) actions of regulatory authorities, which may affect the
initiation, timing and progress of clinical studies or future
regulatory approvals or marketing authorizations; (7) the ability
of Alvotech or its partners to gain approval from regulators for
planned clinical studies, study plans or sites; (8) the ability of
Alvotech’s partners to conduct, supervise and monitor existing and
potential future clinical studies, which may impact development
timelines and plans; (9) 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; (10) the success of Alvotech’s current and future
collaborations, joint ventures, partnerships or licensing
arrangements; (11) Alvotech’s ability, and that of its commercial
partners, to execute their commercialization strategy for approved
products; (12) Alvotech’s ability to manufacture sufficient
commercial supply of its approved products; (13) the outcome of
ongoing and future litigation regarding Alvotech’s products and
product candidates; (14) 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; (15)
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 Alvotech’s business, financial
position, strategy and anticipated milestones; (16) future
liquidity and financing needs; and (17) 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.
[1]
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf
CONTACTSAlvotech Investor
RelationsBenedikt Stefanssonalvotech.ir@alvotech.com
Alvontech (NASDAQ:ALVO)
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