Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for
patients worldwide, today announced that Christina Siniscalchi will
join its corporate leadership team as interim Chief Quality
Officer. Christina succeeds Sandra Casaca, who is leaving the
company as a part of other organizational changes. Christina
Siniscalchi has for over ten years served in senior quality
positions for Alvogen and its manufacturing site in Norwich, NY,
most recently as Alvogen’s Chief Quality Officer.
“We thank Sandra for her valuable contribution to Alvotech, as
she successfully steered our quality team through the recent FDA
facility inspection, which now has led to the approval of our
interchangeable high-concentration biosimilar to Humira in the
U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.
“Christina will be able to hit the ground running, based on her
extensive experience in regulatory compliance and GMP from our
sister company, Alvogen. We are excited to have her on board as we
are hard at work scaling our manufacturing operations for multiple
near-term product launches in global markets. Continuous
improvement, quality, and compliance, is at the heart of everything
we do.”
Christina Siniscalchi has 25 years of experience in the U.S.
pharmaceuticals industry. Prior to joining Norwich Pharmaceuticals,
now Alvogen, she worked at Mallinckrodt Pharmaceuticals. She holds
a Master of Science degree in Regulatory Affairs and Quality
Assurance from Temple University and Bachelor of Science degree in
Applied Biology from Georgia Institute of Technology.
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 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 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, which may impact the anticipated
utilization of the Yorkville facility or other financing sources;
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.
CONTACTSAlvotech Investor Relations and
Global CommunicatoinsBenedikt Stefansson, Senior
Directoralvotech.ir@alvotech.com
Alvontech (NASDAQ:ALVO)
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Alvontech (NASDAQ:ALVO)
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