- The confirmatory clinical, safety and efficacy study for AVT04,
biosimilar candidate to Stelara® (ustekinumab) met its primary
endpoint
- AVT04 (ustekinumab) is part of a broader pipeline of Alvotech’s
biosimilars and biosimilar candidates, which includes AVT02
(adalimumab), a biosimilar to Humira®
- Alvotech is the second company to announce positive top-line
results from a patient study utilizing a biosimilar candidate to
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 results
from a confirmatory clinical study for AVT04, Alvotech’s proposed
biosimilar to Stelara® (ustekinumab). Alvotech is the second
company to announce positive results from a patient study utilizing
a biosimilar candidate to Stelara®. 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 the company’s exclusive
strategic partner for AVT04 for the European market.
In 2021, Stelara’s® worldwide net sales exceeded US$9 billion,
making it one of the highest grossing biologic medicines.
Ustekinumab is a human IgG1κ monoclonal antibody that binds with
specificity to the p40 protein subunit present in both the IL-12
and IL-23 cytokines. Stelara® is prescribed to treat a variety of
inflammatory conditions including psoriatic arthritis, Crohn’s
disease, ulcerative colitis, and plaque psoriasis.
The confirmatory clinical trial (AVT04-GL-301) is a randomized,
double-blind, multicenter study designed to demonstrate equivalent
efficacy and to compare safety and immunogenicity between AVT04 and
Stelara® in patients with moderate to severe chronic plaque-type
psoriasis. The study met its primary endpoint, with results
demonstrating therapeutic equivalence between Alvotech’s biosimilar
candidate and Stelara®. In addition, no clinically meaningful
differences in safety were observed through week 28. Earlier this
month, Alvotech announced positive top-line results from a
pharmacokinetic (PK) similarity study for AVT04.
“The progress of our proposed biosimilar to Stelara® highlights
the advantage of our global, vertically integrated platform,” said
Robert Wessman, Founder and Chairman of Alvotech. “Completing this
clinical milestone, less than one year since we recruited the first
subject, truly demonstrates the success of our clinical development
and integrated approach to rapidly advancing multiple high-quality
biosimilar candidates.”
Mark Levick, Chief Executive Officer of Alvotech, added: “We
believe that using the same type of host cell line as the reference
product enables matching the post-translational modifications to
the best extent possible.”
Alvotech’s portfolio of eight products and product candidates
includes AVT02 (adalimumab), a biosimilar to Humira® and seven
proposed biosimilars, inclusive of AVT04 (ustekinumab), a proposed
biosimilar to Stelara®. Alvotech has built a highly integrated
platform focused on development and manufacturing and has
established a global network of commercial partnerships in all
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 S.A. 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-301 efficacy, safety, and
immunogenicity study
The AVT04-GL-301 study was conducted in four countries in Europe
and enrolled 581 patients. It was a randomized, double-blind,
multicenter study designed to demonstrate equivalent efficacy and
to compare safety and immunogenicity between AVT04 and Stelara®
(ustekinumab) in patients with moderate to severe chronic
plaque-type psoriasis. The study met its primary endpoint, with
results demonstrating therapeutic equivalence between Alvotech’s
biosimilar candidate and Stelara®. In addition, no clinically
meaningful differences in safety were observed through week 28. The
primary efficacy endpoint was Psoriasis Area and Severity Index
(PASI) percent improvement from Baseline at Week 12. The key
secondary endpoints include additional efficacy parameters, like
quality-of-life scores, safety, immunogenicity, tolerability
parameters, and pharmacokinetic (PK) data.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to
Stelara® (ustekinumab). AVT04 was developed using an Sp2/0 host
cell line and is manufactured using a continuous perfusion process.
The Sp2/0 host cell line allows for more efficient sialyation of
the molecule as compared to Chinese hamster ovary (CHO) cells and
is the same type of host cell line used to produce Stelara®.
Ustekinumab binds to two cytokines, IL-12 and IL-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). AVT02 is approved in the EU, the United Kingdom,
Switzerland, Norway, Iceland, Lichtenstein (Hukyndra®) and Canada
(Simlandi™). AVT02 dossiers are under review in multiple countries;
in the U.S. 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 disease, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220524005635/en/
ALVOTECH
Corporate Communications Alvotech.media@alvotech.com
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
OAKTREE ACQUISITION CORP. II
Investor Relations info@oaktreeacquisitioncorp.com
Media Relations mediainquiries@oaktreecapital.com
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