- The U.S. Food and Drug Administration’s (FDA) regulatory
review is anticipated to be completed in second half of 2023
- Stelara® (ustekinumab) is prescribed to treat a variety of
inflammatory conditions
Alvotech (NASDAQ: ALVO), a global biotech company specializing
in the development and manufacture of biosimilar medicines for
patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review a Biologics License Application (BLA) for
AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab),
which is prescribed to treat a variety of inflammatory conditions.
The companies anticipate that the FDA’s review will be completed in
second half of 2023.
"The progress of AVT04 helps to validate the end-to-end
biosimilars development and manufacturing platform that we have
built at Alvotech," said Joseph McClellan, Chief Scientific Officer
of Alvotech. "Our approach is multi-product, and we look forward to
broadening our portfolio as we continue to focus on expanding
access to affordable biologic medicines."
“We are pleased to be one step closer to making AVT04 available
to patients and providers as a biosimilar treatment option to
Stelara® for indicated inflammatory conditions,” said Christine
Baeder, SVP, Chief Operating Officer US Generics, Teva. “Teva
continues to remain focused on our commitment to lower healthcare
costs and expand the availability and access of biosimilars.”
In August 2020, Alvotech and Teva announced a strategic
partnership for the exclusive commercialization in the U.S. of five
of Alvotech’s biosimilar product candidates. In May 2022, Alvotech
announced that a confirmatory clinical, safety and efficacy study
for AVT04 had met its primary endpoint, in demonstrating
therapeutic equivalence between Alvotech’s biosimilar candidate and
the reference product in patients with moderate to severe chronic
plaque-type psoriasis. Earlier in May 2022, Alvotech also announced
positive top-line results from a pharmacokinetic (PK) similarity
study for AVT04.
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 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.
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
specialty 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 specialty 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,
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.
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 risks relating to our ability to develop our
biosimilar products pipeline; 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;
costs and delays resulting from the extensive pharmaceutical
regulation to which we are subject to, or delays in governmental
processing time due to travel and work restrictions caused by the
COVID-19 pandemic; 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 third
quarter of 2022 and in our Annual Report on Form 10-K for the year
ended December 31, 2021, 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/20230106005021/en/
Alvotech Investor Relations and Global Communications
Benedikt Stefansson alvotech.ir[at]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
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