- Results from pharmacokinetic (PK) similarity study demonstrate
bioequivalence of AVT04 (ustekinumab) to the reference product
Stelara®
Alvotech Holdings S.A. (“Alvotech”), a global biotech company
focused solely on the development and manufacture of biosimilar
medicines for patients worldwide, today announced positive top-line
results from a pharmacokinetic (PK) study for AVT04, Alvotech’s
proposed biosimilar to Stelara® (ustekinumab).
The PK similarity study (AVT04-GL-101) utilized a single dose,
3-arm, parallel design to compare pharmacokinetics, safety,
tolerability, and immunogenicity of a single 45mg/0.5mL
subcutaneous dose of AVT04, with US-licensed Stelara®, as well as
EU-approved Stelara®. The study results demonstrated bioequivalence
between AVT04 and the reference products.
Ustekinumab is a human IgG1κ monoclonal antibody that binds with
specificity to the p40 protein subunit used by both the
interleukin-12 and interleukin-23 cytokines. Stelara® is prescribed
to treat a variety of inflammatory conditions including psoriatic
arthritis, Crohn’s disease, ulcerative colitis, and plaque
psoriasis. In 2021, Stelara’s worldwide net sales exceeded US$9
billion, making it one of the highest grossing biologic medicines.
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic
partner for the commercialization of AVT04 in the United States.
STADA is Alvotech’s exclusive strategic partner for AVT04 for the
European market.
“We are delighted at the continued progress of our pipeline of
biosimilar candidates,” said Robert Wessman Founder and Chairman of
Alvotech. “This continued progress demonstrates the strength of
Alvotech’s purpose-built biosimilar platform.”
Chief Scientific Officer, Joseph McClellan added, “We are
pleased with the successful outcome of the AVT04 PK similarity
study and the continued progress of our overall pipeline. We expect
the results from our confirmatory efficacy and safety study for
AVT04 before the end of the 2nd quarter.”
Alvotech’s product portfolio includes AVT02, a biosimilar to
Humira® (adalimumab). In addition to AVT04, Alvotech is advancing
six other biosimilar candidates, using its highly integrated
platform for development and manufacturing. Alvotech has
established a global network of commercial partnerships in major
markets, with the goal of expeditiously delivering its
cost-effective biosimilar medicines to patients worldwide.
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., (“OACB”) 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.” On May 11, 2022, Alvotech and OACB
announced that the extraordinary general meeting of shareholders of
OACB to approve the pending business combination between Alvotech,
OACB and the legal entity named Alvotech, previously named Alvotech
Lux Holdings S.A.S., (“TopCo”) is scheduled to be held on June 7,
2022.
About the AVT04-GL-101 pharmacokinetics, safety, and
tolerability study
The AVT04-GL-101 pharmacokinetic (PK) study was conducted in
Australia and New Zealand and enrolled 294 healthy adult
volunteers. The study involved a single dose, 3-arm, parallel
design to compare pharmacokinetics, safety, tolerability, and
immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04,
with US-licensed Stelara®, as well as EU-approved Stelara®.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to
Stelara® (ustekinumab). AVT04 was developed using the Sp2/0 host
cell line and is manufactured using a continuous perfusion process.
Ustekinumab binds to two cytokines called interleukin-12 and
interleukin-23 that are involved in inflammatory and immune
responses. Abnormal regulation of these cytokines has been
associated with immune mediated diseases, such as psoriasis,
psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and a biosimilar to Humira®
(adalimumab), which inhibits tumor necrosis factor alpha
(TNF-alpha). AVT02 is not approved outside of the EU, UK, and
Canada. AVT02 dossiers are under review in multiple countries; in
the US the initial BLA for approval as a biosimilar is in deferred
status, pending the result of FDA inspections.
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 contains eight biosimilar candidates aimed at
treating autoimmune disorders, eye disorders, osteoporosis,
respiratory diseases, and cancer. For more information, please
visit www.alvotech.com.
Additional Information
In connection with the proposed business combination between
OACB, Alvotech Holdings S.A. and TopCo, the parties have filed with
the U.S. Securities and Exchange Commission a Registration
Statement on Form F-4 (as amended or supplemented through the date
hereof, the “Registration Statement”) containing a proxy statement
of OACB and a prospectus of TopCo. The Registration Statement has
been declared effective by the SEC and OACB has mailed a definitive
proxy statement/prospectus related to the proposed Business
Combination to its shareholders. The extraordinary general meeting
of shareholders of OACB to approve the business combination is
scheduled to be held on June 7, 2022. 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 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 Holdings S.A., OACB and the
proposed Business Combination. Shareholders of OACB can also obtain
copies of the definitive proxy statement/prospectus and other
documents filed with the SEC, without charge at the SEC’s website
at www.sec.gov, or by directing a written request to: Oaktree
Acquisition Corp. II, 333 South Grand Avenue, 28th Floor, Los
Angeles, California 90071.
Participants in the Solicitation
OACB and Alvotech Holdings S.A. 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 for the fiscal year ended
December 31, 2021, which was filed with the SEC and is available
free of charge at the SEC’s website at www.sec.gov, or by directing
a written request to Oaktree Acquisition Corp. II, 333 South Grand
Avenue, 28th Floor, Los Angeles, California 90071. Additional
information regarding the interests of such participants is
contained in the definitive proxy statement/prospectus for the
proposed Business Combination.
TopCo 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 are included in the definitive proxy
statement/prospectus for the proposed Business Combination.
Forward-Looking Statements
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; the timing of the announcement
of clinical trial results, including safety study for AVT04; the
timing of the extraordinary general meeting of shareholders of OACB
to approve the business combination; 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) the
inability to execute final agreement with respect to the loan
facility with Sculptor on acceptable terms or at all; (5) the
inability to consummate the transactions contemplated by the SEPA;
(6) 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; (7) the ability to meet stock exchange
listing standards following the consummation of the Business
Combination; (8) 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; (9) 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; (10) costs related to the Business
Combination; (11) changes in applicable laws or regulations; (12)
the possibility that Alvotech or the combined company may be
adversely affected by other economic, business, and/or competitive
factors; (13) Alvotech’s estimates of expenses and profitability;
(14) Alvotech S.A.’s ability to develop, manufacture and
commercialize its product candidates in its pipeline; (15) actions
of regulatory authorities, which may affect the initiation, timing
and progress of clinical trials or future regulatory approvals or
marketing authorizations; (16) Alvotech S.A.’s ability to obtain
and maintain regulatory approval or authorizations of its product
candidates, including the timing or likelihood of expansion into
additional markets or geographies; (17) the success of Alvotech’s
current and future collaborations, joint ventures, partnerships or
licensing arrangements; (18) Alvotech’s ability, and that of its
commercial partners, to execute their commercialization strategy
for approved products; (19) Alvotech’s ability to manufacture
sufficient commercial supply of its approved products; (20) the
outcome of ongoing and future litigation regarding Alvotech’s
products and product candidates; (21) 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 (22) 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
for the fiscal year ended December 31, 2021, in the Registration
Statement 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220516005128/en/
ALVOTECH HOLDINGS S.A.
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
Oaktree Acquisition Corp... (NYSE:OACB)
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