Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for
patients worldwide, today announced changes to the company’s
Quality unit. Sandra Casaca has been appointed Chief Quality
Officer of Alvotech and Sarah Tanksley will be joining the Board of
Directors of Alvotech hf., the operating entity for Alvotech’s
manufacturing site in Iceland.
“I want to thank Sarah for her strong leadership and commitment
to Alvotech. We are excited to be able to work with her in a board
capacity where she will continue to provide valuable input and
oversight on quality, compliance, and regulatory matters,” said
Robert Wessman, founder, chairman and CEO of Alvotech. “It is also
a great pleasure to welcome Sandra to our team. Sandra is an
accomplished quality executive with a demonstrated history of
excellence in both drug development and commercial manufacturing
operations in the U.S., Europe, Canada and Latin America. She will
be based in Iceland, as Alvotech continues to strengthen the local
leadership.”
Sandra Casaca brings more than 25 years of experience in the
pharmaceutical sector internationally and has a strong background
in quality for biologics manufacturing. She previously held senior
leadership positions in quality at leading companies in the life
sciences, including BMS, Amgen, AbbVie and Atara. Ms. Casaca holds
a master’s degree in Pharmaceutical Science from the University of
Lisbon.
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), 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 Statements 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 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 review and
interactions, 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 and market launches, and the
estimated size of the total addressable market of Alvotech’s
pipeline products. 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) 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 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.
CONTACT
Alvotech Investor Relations and Global
CommunicationsBenedikt
Stefanssonalvotech.ir@alvotech.com
Alvontech (NASDAQ:ALVO)
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Alvontech (NASDAQ:ALVO)
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から 12 2023 まで 12 2024