Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company
specializing in the development and manufacture of biosimilar
medicines for patients worldwide, announced today that Faysal
Kalmoua has been appointed Alvotech’s Chief Operating Officer and
Hafrun Fridriksdottir is stepping down following resubmission of
the Biologics License Application (BLA) for AVT02, Alvotech’s
proposed high-concentration interchangeable biosimilar to Humira®
(adalimumab).
Faysal has served as Head of Portfolio and Project
Management since earlier this year and as a member of Alvotech’s
Board of Directors since 2020. Previously, he held various senior
management positions at Alvogen and Synthon. He has a master’s
degree in Chemistry from Radboud University Nijmegen and an
executive MBA from Insead.
“It is a great pleasure to welcome Faysal to the role of Chief
Operating Officer, as he knows our operations and portfolio
intimately,” said Robert Wessman, Chairman and CEO of Alvotech. “We
were extremely grateful last year when Hafrún agreed to lend her
extensive pharma industry experience to the Alvotech team, and her
passion for operational excellence and quality will continue to be
an inspiration for the entire team.”
“I am thrilled to take part in Alvotech’s remarkable journey,”
said Faysal Kalmoua. “I look forward to continue working with the
exceptionally talented and dedicated team assembled and
contributing to the Company’s further development into a global
leader in the biosimilars industry.”
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, including the resubmission of a BLA for AVT02 and
a potential reinspection of Alvotech’s manufacturing facility, the
satisfactory responses to the FDA’s inspection findings and
resolution of other deficiencies conveyed following the inspection
of Alvotech’s manufacturing site, the potential approval and
commercial launch of its product candidates, the timing of
regulatory approval, including for AVT04, and market launches, the
estimated size of the total addressable market of Alvotech’s
pipeline products, the availability of financing options, including
the size, timeline, securities, terms and conditions of, and use of
proceeds from, a potential financing. 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) 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 respond to inspection findings and resolve deficiencies
to the satisfaction of the regulators; (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.
CONTACTSAlvotech Investor
RelationsBenedikt Stefanssonalvotech.ir@alvotech.com
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