Alvotech expects AVT02 (adalimumab) will be
marketed in the U.S., subject to regulatory approval, on July 1,
2023
All ongoing U.S. disputes between AbbVie and
Alvotech have been resolved, including the ITC action brought forth
in December 2021
Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical
company focused solely on the development and manufacture of
biosimilar medicines for patients worldwide, announced today that
is has executed a U.S. settlement agreement with AbbVie (NYSE:
ABBV) that grants Alvotech non-exclusive rights to market AVT02
(100mg/mL), its high-concentration, citrate-free biosimilar
candidate for Humira® (adalimumab) in the United States. The
settlement grants Alvotech a license entry date in the United
States of July 1, 2023.
The settlement fully resolves all pending U.S. disputes between
AbbVie and Alvotech related to AVT02, including the United States
International Trade Commission (ITC) case brought forth in December
2021, thus removing any corresponding litigation-related barriers
blocking Alvotech’s high-concentration version of adalimumab from
reaching U.S. patients.
“We aim to be the first interchangeable, high-concentration
biosimilar to this critical treatment,” said Robert Wessman,
Founder and Chairman of Alvotech. “We view today as a key milestone
for patients and for our mission to fight for healthcare
sustainability.”
Alvotech is the only known company that has both developed a
high-concentration biosimilar candidate to Humira and conducted a
switching study, to support potential approval as an
interchangeable product. While both low-concentration and
high-concentration strengths of Humira are marketed in the U.S.
today, over 80 percent of prescriptions are for the
high-concentration strengths. In 2021, AbbVie’s sales of Humira
topped $20.7 billion, making it the highest grossing pharmaceutical
product in the world, excluding COVID-19 vaccines. Teva
Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries
Ltd. (NYSE and TASE: TEVA), is Alvotech’s exclusive strategic
partner for the commercialization of AVT02 in the United
States.
In the U.S., an interchangeable product is a biosimilar product
that meets additional requirements outlined by the Biologics Price
Competition and Innovation Act. As part of fulfilling these
additional requirements, information is needed to show that an
interchangeable product is expected to produce the same clinical
result as the reference product in any given patient. Also, for
products administered to a patient more than once, the risk in
terms of safety and reduced efficacy of switching back and forth
between an interchangeable product and a reference product will
have been evaluated. An interchangeable product may be substituted
for the reference product without the involvement of the
prescriber.1
AVT02 has received approval in Europe, Canada, and the United
Kingdom. In the U.S., Alvotech announced in September 2021 that the
FDA is deferring action on its BLA that was accepted in November
2020. The FDA can defer action when no deficiencies have been
identified and the application otherwise satisfies the requirements
for approval, but an inspection(s) is necessary yet cannot be
completed due to factors including travel restrictions1. Currently,
inspections have been scheduled for the requisite facilities and
are expected to occur in Q1 and Q2 of 2022. In February 2022,
Alvotech announced that the FDA has accepted for review the
company’s Biologics Licensing Application (BLA) for ATV02 (100
mg/mL) that includes new data supporting interchangeability between
ATV02 and Humira.
1 US Food and Drug Administration
On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II
(NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition
company sponsored by an affiliate of Oaktree Capital Management,
L.P., announced they had entered into a definitive business
combination agreement. Upon completion of the transaction, the
combined company’s securities are expected to be traded on NASDAQ
under the symbol “ALVO.”
About Alvotech
Alvotech is a biopharmaceutical company 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, and cancer. For more information, please visit
www.alvotech.com.
About AVT02
AVT02 is a monoclonal antibody and a biosimilar to Humira
(adalimumab). AVT02 is not approved outside of the EU, Canada, and
the United Kingdom. AVT02 dossiers are under review in multiple
countries; in the U.S. the BLA is in deferred status, pending FDA
inspection(s).
Additional Information
In connection with the proposed business combination (the
“Business Combination”) between OACB and Alvotech. OACB and
Alvotech have filed with the U.S. Securities and Exchange
Commission (the “SEC”) a Registration Statement on Form F-4 (the
“Registration Statement”) containing a preliminary proxy statement
of OACB and a preliminary prospectus of Alvotech Lux Holdings
S.A.S., and after the Registration Statement is declared effective,
OACB will mail a definitive proxy statement/prospectus related to
the proposed Business Combination to its shareholders. This
communication does not contain all the information that should be
considered concerning the proposed Business Combination and is not
intended to form the basis of any investment decision or any other
decision in respect of the proposed Business Combination. OACB’s
shareholders and other interested persons are advised to read, when
available, the preliminary proxy statement/prospectus and the
amendments thereto and the definitive proxy statement/prospectus
and other documents filed in connection with the proposed Business
Combination, as these materials will contain important information
about Alvotech, OACB and the proposed Business Combination. When
available, the definitive proxy statement/prospectus and other
relevant materials for the proposed Business Combination will be
mailed to shareholders of OACB as of a record date to be
established for voting on the proposed Business Combination.
Shareholders of OACB will also be able to obtain copies of the
preliminary proxy statement/prospectus, the definitive proxy
statement/prospectus and other documents filed with the SEC,
without charge, once available, at the SEC’s website at
www.sec.gov, or by directing a written request to: OACB, 333 South
Grand Avenue, 28th Floor, Los Angeles, California 90071.
Participants in the Solicitation
OACB and Alvotech and their directors and executive officers may
be deemed participants in the solicitation of proxies from OACB’s
shareholders with respect to the Business Combination. A list of
the names of those directors and executive officers and a
description of their interests in OACB is contained in OACB’s
annual report on Form 10-K/A for the fiscal year ended December 31,
2020 (as amended December 13, 2021), which was filed with the SEC
and is available free of charge at the SEC’s web site at
www.sec.gov, or by directing a written request to OACB, 333 South
Grand Avenue, 28th Floor, Los Angeles, California 90071. Additional
information regarding the interests of such participants will be
contained in the proxy statement/prospectus for the proposed
Business Combination when available.
Alvotech Lux Holdings S.A.S and its directors and executive
officers may also be deemed to be participants in the solicitation
of proxies from the shareholders of OACB in connection with the
proposed Business Combination. A list of the names of such
directors and executive officers and information regarding their
interests in the proposed Business Combination will be included in
the proxy statement/prospectus for the proposed Business
Combination when available.
Forward-Looking Statement
Certain statements in this communication may be considered
“forward-looking statements.” Forward-looking statements generally
relate to future events or the future financial operating
performance of OACB or Alvotech. For example, Alvotech’s
expectations regarding future growth, results of operations,
performance, future capital and other expenditures including the
development of critical infrastructure for the global healthcare
markets, 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; and the potential approval and
commercial launch of AVT02. In some cases, you can identify
forward-looking statements by terminology such as “may”, “should”,
“expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”,
“predict”, “potential” 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 OACB and its
management, and Alvotech and its management, as the case may be,
are inherently uncertain and are inherently subject to risks,
variability and contingencies, many of which are beyond OACB’s and
Alvotech’s control. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to: (1) the occurrence of any event, change or other circumstances
that could give rise to the termination of negotiations and any
subsequent definitive agreements with respect to the Business
Combination; (2) the outcome of any legal proceedings that may be
instituted against OACB, the combined company or others following
this announcement of the Business Combination and any definitive
agreements with respect thereto; (3) the inability to complete the
Business Combination due to the failure to obtain approval of the
shareholders of OACB, to obtain financing to complete the Business
Combination or to satisfy other conditions to closing; (4) changes
to the proposed structure of the Business Combination that may be
required or appropriate as a result of applicable laws or
regulations or as a condition to obtaining regulatory approval of
the Business Combination; (5) the ability to meet stock exchange
listing standards following the consummation of the Business
Combination; (6) the risk that the Business Combination disrupts
current plans and operations of Alvotech as a result of the
announcement and consummation of the Business Combination; (7) the
ability to recognize the anticipated benefits of the Business
Combination, which may be affected by, among other things,
competition, the ability of the combined company to grow and manage
growth profitably, maintain key relationships and retain its
management and key employees; (8) costs related to the Business
Combination; (9) changes in applicable laws or regulations; (10)
the possibility that Alvotech or the combined company may be
adversely affected by other economic, business, and/or competitive
factors; (11) Alvotech’s estimates of expenses and profitability;
(12) pending litigation related to AVT02; (13) 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; and (14) other risks and uncertainties set
forth in the section entitled “Risk Factors” and “Cautionary Note
Regarding Forward-Looking Statements” in OACB’s Annual Report on
Form 10-K/A for the fiscal year ended December 31, 2020 (as amended
May 19, 2021) or in other documents filed by OACB with the SEC.
There may be additional risks that neither OACB nor Alvotech
presently know or that OACB and Alvotech currently believe 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. Neither OACB nor Alvotech undertakes 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 and OACB disclaim 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, OACB or any of their respective 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.
No Offer
This communication is for informational purposes only and does
not constitute an offer to sell or a solicitation of an offer to
buy any securities pursuant to the proposed transaction or
otherwise, nor shall there be any sale of any such securities in
any state or jurisdiction in which such offer, solicitation, or
sale would be unlawful prior to registration or qualification under
the securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
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version on businesswire.com: https://www.businesswire.com/news/home/20220308006344/en/
ALVOTECH
Investor Relations Stephanie Carrington ICR Westwicke
Stephanie.Carrington@westwicke.com (646) 277-1282
Media Relations Sean Leous ICR Westwicke
Sean.Leous@westwicke.com (646) 866-4012
Corporate Communications Alvotech.media@alvotech.com
OAKTREE ACQUISITION CORP. II
Investor Relations info@oaktreeacquisitioncorp.com
Media Relations mediainquiries@oaktreecapital.com
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