- Alvotech will manufacture its high-concentration
interchangeable biosimilar to Humira® (adalimumab) for Quallent
Pharmaceuticals
- The strategic agreement is in alignment with Alvotech’s U.S.
commercialization agreement with Teva Pharmaceuticals
- The high-concentration interchangeable biosimilar to Humira®
manufactured by Alvotech will be distributed under Quallent’s
private-label
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),
disclosed today that under the recently announced U.S. strategic
partnership agreement, Alvotech will manufacture its
high-concentration interchangeable biosimilar to Humira®
(adalimumab) for Quallent Pharmaceuticals with, in alignment with
its U.S. commercialization agreement with Teva. The interchangeable
biosimilar will be distributed under Quallent’s private label.
“We are pleased to be working with Alvotech to bring
adalimumab-ryvk to more patients. Our intent is to offer a copay
assistance program, which will provide eligible patients access,”
said John Caufield, President of Quallent Pharmaceuticals Health,
LLC. “Quallent was established to help pharmacies give their
patients safe and affordable medication, and this collaboration
will help us deliver on this goal.”
“Being able to obtain interchangeable exclusivity for the
high-concentration formulation which dominates the adalimumab
market, has generated significant payor interest for this unique
product in the U.S. market. With our commercial partners for the
U.S., we aim to increase healthcare access and ensure that
affordable high-quality biologics are available to patients in
need,” said Robert Wessman, Chairman and CEO of Alvotech.
“At Teva we continue to be focused on creating cost savings
across the healthcare system and providing affordable options, like
the high-concentration interchangeable adalimumab, for patients who
need them,” said Thomas Rainey, Senior Vice President, U.S. Market
Access at Teva. “The strategic partnership between Teva and
Alvotech has already yielded two approved critical biosimilars,
from a portfolio of nine partnered products. Two partnered
biosimilar candidates are coming out of clinical development this
year.”
The U.S. Food and Drug Administration (FDA) approved Alvotech’s
biosimilar on February 24, 2024, as a high-concentration
interchangeable biosimilar to Humira, for the treatment of adult
rheumatoid arthritis, juvenile idiopathic arthritis, adult
psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease,
adult ulcerative colitis, adult plaque psoriasis, adult
hidradenitis suppurativa and adult uveitis. This is the first
high-concentration, citrate-free biosimilar to Humira® granted an
interchangeability status by the FDA and Alvotech will have
interchangeable exclusivity for the 40mg/0.4mL strength. Nearly 88
percent of U.S. prescriptions for adalimumab are for the
high-concentration presentations [1].
In August 2020, Alvotech and Teva entered into a strategic
partnership for the exclusive commercialization of five of
Alvotech’s biosimilar product candidates, and in August 2023 the
partners extended the partnership to include two additional
biosimilars and two new presentations of previously partnered
products. Alvotech handles development and manufacturing, and Teva
is responsible for U.S. commercialization, which leverages Teva’s
extensive experience and sales and marketing infrastructure.
Alvotech’s high concentration interchangeable biosimilar to Humira®
(adalimumab) was the first biosimilar approved under the strategic
partnership, and Teva expects to launch it to patients in the U.S.
imminently.
Use of Trademarks
Humira® is a registered trademark of AbbVie Biotechnology
Ltd.
Sources
[1] Based on sales data from Symphony
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global pharmaceutical leader with a category-defying portfolio,
harnessing our generics expertise and stepping up innovation to
continue the momentum behind the discovery, delivery, and expanded
development of modern medicine. For over 120 years, Teva's
commitment to bettering health has never wavered. Today, the
company’s global network of capabilities enables its ~37,000
employees across 58 markets to push the boundaries of scientific
innovation and deliver quality medicines to help improve health
outcomes of millions of patients every day. To learn more about how
Teva is all in for better health, visit www.tevapharm.com.
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 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.
Alvotech 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 submissions, review and interactions, the
potential approval and commercial launch of its product candidates,
the timing of regulatory approval, and market launches. 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 ability to
raise substantial additional funding, which may not be available on
acceptable terms or at all; (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 impact of worsening
macroeconomic conditions, including rising inflation and interest
rates and general market conditions, conflicts in Ukraine, the
Middle East and other global geopolitical tension, on the Company’s
business, financial position, strategy and anticipated milestones;
and (18) 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.
TEVA Cautionary Note Regarding Forward Looking
Statements
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 strategic partnership
with Alvotech; our ability to successfully commercialize SIMLANDI
in the U.S.; our ability to commercialize the additional biosimilar
product candidates under the strategic partnership with Alvotech,
once U.S. regulatory approval is obtained; our ability to
successfully compete in the marketplace; our ability to develop and
commercialize additional pharmaceutical products; our ability to
successfully execute our Pivot to Growth strategy, including to
expand our innovative and biosimilar medicines pipeline and
profitably commercialize the innovative medicines and biosimilar
portfolio, whether organically or through business development, and
to sustain and focus our portfolio of generics medicines; and other
factors discussed in this press release, and in our Annual Report
on Form 10-K for the year ended December 31, 2023, including in the
sections 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240430868675/en/
CONTACTS FOR THE MEDIA AND IR ALVOTECH Investor
Relations and Global Communications Benedikt Stefansson, Senior
Director alvotech.ir@alvotech.com TEVA
IR Contacts Ran Meir +1 (267) 468-4475 Yael Ashman +972
(3) 914 8262 Sanjeev Sharma +1 (973) 658 2700 PR Contacts
Kelley Dougherty +1 (973) 832-2810 Yonatan Beker +1 (973) 264-7378
Eden Klein +972 (3) 906 2645
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