Alvotech and Advanz Pharma Sign Commercialization Agreement for
Proposed Biosimilar to Eylea® LD/HD in Europe
- Advanz Pharma secures rights to commercialize Alvotech’s
biosimilar candidate for Eylea® in Europe
- Advanz Pharma will leverage its existing specialty and hospital
capabilities in Europe to ensure successful market registration,
commercialization, and patient access
REYKJAVIK, ICELAND and LONDON, UK (June
18, 2024) — Alvotech (NASDAQ: ALVO), a global biotech
company specializing in the development and manufacture of
biosimilar medicines for patients worldwide and Advanz Pharma, a UK
headquartered global pharmaceutical company with a strategic focus
on specialty, hospital, and rare disease medicines in Europe, today
announced that the companies have entered into an exclusive
partnership agreement regarding the supply and commercialization of
Alvotech’s proposed biosimilar to Eylea® (aflibercept). Alvotech is
currently developing AVT06, a proposed biosimilar to Eylea® low
dose (2 mg) and AVT29 a biosimilar candidate for Eylea® high dose
(8 mg).
Eylea® is a widely used biologic for the treatment of eye
disorders, including diseases which can lead to vision loss or
blindness, such as wet AMD, macular edema, and diabetic
retinopathy. In 2023, reported sales of Eylea® in Europe were $2.9
billion [1].
Under the agreement Alvotech will be responsible for development
and commercial supply of AVT06 and AVT29 and Advanz Pharma will be
responsible for registration and commercialization. Advanz Pharma
has exclusive commercialization rights in Europe, except for
Germany and France where the rights are semi-exclusive. The
commercialization agreement includes an upfront payment to Alvotech
with subsequent payments upon certain development and
commercialization milestones.
"We value our growing partnership with Advanz Pharma which
started early last year and has now been expanded to a total of
seven biosimilar candidates. We share a common vision for the
growth of the biosimilars market and a strong commitment to
providing broader patient access to more affordable biologics,”
said Anil Okay, Chief Commercial Officer of Alvotech.
Susanna El-Armale, Chief Corporate Development Officer at Advanz
Pharma, said: “We are excited to reinforce our collaboration with
Alvotech by adding an impactful and meaningful product to our
growing pipeline. This partnership leverages our combined strengths
and reinforces Advanz Pharma as a partner of choice for the
commercialization of specialty pharmaceuticals in Europe.”
In January 2024 Alvotech announced positive top-line results
from a confirmatory patient study evaluating the efficacy, safety,
and immunogenicity of AVT06 compared with Eylea® in patients with
neovascular (wet) AMD. The study met its primary endpoint, with
results demonstrating therapeutic equivalence between Alvotech’s
biosimilar candidate and Eylea®.
In February 2023 Alvotech and Advanz Pharma announced that the
companies had entered into an exclusive agreement for the
commercialization of AVT23, a proposed biosimilar to Xolair®
(omalizumab). The agreement covers the European Economic Area, UK,
Switzerland, Canada, Australia, and New Zealand. In May 2023
Alvotech and Advanz Pharma announced that the companies had
expanded their partnership to include biosimilar candidates to
Simponi® (golimumab) and Entyvio® (vedolizumab) and as well as
three additional early-stage, undisclosed biosimilar
candidates.
About AVT06/AVT29AVT06/AVT29 is a recombinant
fusion protein and a biosimilar candidate to Eylea® (aflibercept),
which binds vascular endothelial growth factors (VEGF), inhibiting
the binding and activation of VEGF receptors, neovascularization,
and vascular permeability [2]. AVT06/AVT29 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.
Sources[1] IQVIA sales data[2]
https://www.regeneron.com/downloads/eylea_fpi.pdf
Use of TrademarksEylea® is a registered
trademark of Regeneron Pharmaceuticals Inc. and Bayer AG
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.
For more information please visit our investor portal, and our
website or follow us on social media on LinkedIn, Facebook,
Instagram, X and YouTube.
About Advanz PharamPartner of choice in
specialty, hospital, and rare disease medicines. Advanz Pharma is a
global pharmaceutical company with the purpose to improve patients’
lives by providing and enhancing the specialty, hospital, and rare
disease medicines they depend on. Our headquarters are in London,
UK. We have commercial sales in more than 90 countries globally and
have a direct commercial presence in more than 20 countries,
including key countries in Europe, the US, Canada, and Australia, a
Centre of Excellence in Mumbai, India, as well as an established
global distribution and commercialization partner network. Advanz
Pharma’s product portfolio and pipeline comprises innovative
medicines, specialty generics & biosimilars, and originator
brands. Our products cover a broad range of therapeutic areas,
including hepatology, gastroenterology, anti-infectives, critical
care, endocrinology, oncology, CNS, and, more broadly, rare disease
medicines. Our ambition is to be a partner of choice for the
commercialization of specialty, hospital, and rare disease
medicines in Europe, Canada, and Australia. In line with our
ambition, we are partnering with biopharma and development
companies to bring medicines to patients. We can only achieve this
due to our dedicated and highly qualified employees, acting in line
with our company values of entrepreneurship, speed, and
integrity.
Alvotech 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, 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.
Advanz Forward Looking StatementsCertain
statements in this press release are forward-looking statements.
These statements may be identified by words such as “anticipate”,
"expectation", "belief', "estimate", "plan", "target”, “project”,
“will”, “may”, “should” or "forecast" and similar expressions, or
by their context. Although ADVANZ believes that these assumptions
were reasonable when made, by their nature, forward-looking
statements involve a number of risks, uncertainties and assumptions
that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These
risks, uncertainties and assumptions could adversely affect the
outcome and financial consequences of the plans and events
described herein. Actual results may differ from those set forth in
the forward-looking statements as a result of various factors
(including, but not limited to, future global economic conditions,
changed market conditions affecting the industry, intense
competition in the markets in which Advanz operates, costs of
compliance with applicable laws, regulations and standards, diverse
political, legal, economic and other conditions affecting Advanz’s
markets, and other factors beyond the control of Advanz. Neither
ADVANZ nor any of its directors, officers, employees, advisors, or
any other person is under any obligation to update or keep current
the information contained in this press release or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise. You should not place undue reliance on
forward-looking statements, which speak of the date of this press
release. Statements contained in this press release regarding past
trends or events should not be taken as a representation that such
trends or events will continue in the future. No obligation is
assumed to update any forward-looking statements. The information
contained in this press release is provided as at the date of this
document and is subject to change without notice.
CONTACTSAlvotech Investor Relations and
Global CommunicationsBenedikt
Stefanssonalvotech.ir@alvotech.com
Advanz PharmaCourtney BainesTel: +44 7776
516979 courtney.baines@advanzpharma.com