- Upon launch, HUKYNDRA® will be one of two citrate-free,
high-concentration adalimumab biosimilars on the European
market
- All intellectual-property disputes related to market entry of
Alvotech’s AVT02 (adalimumab) in the U.S. and Europe are now
resolved
Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical
company focused solely on the development and manufacture of
biosimilar medicines for patients worldwide, has today announced
the resolution of all intellectual property disputes with AbbVie in
Europe and selected markets outside of Europe, related to its AVT02
biosimilar candidate. This paves the way for Alvotech’s exclusive
strategic partner STADA to commercialize AVT02, a citrate-free,
high-concentration (100 mg/mL) biosimilar to Humira® (adalimumab)
in European countries under the HUKYNDRA® brand name.
Under the terms of the European patent resolution, AbbVie has
granted Alvotech a non-exclusive, royalty bearing license to
AbbVie’s intellectual property relating to Humira® in Europe and in
selected markets outside of Europe, thus paving the way for greater
patient access to adalimumab.
“This resolution is an important step in Alvotech’s mission to
bring more sustainable healthcare to patients in need and we look
forward to launching our first biosimilar in the European market
with STADA,” said Robert Wessman, Founder and Chairman of
Alvotech.
With all intellectual-property issues now resolved, STADA is
preparing to launch the HUKYNDRA citrate-free, high-concentration
biosimilar broadly across Europe. STADA is Alvotech’s exclusive
strategic partner for commercializing AVT02 in Europe and selected
other territories.
“HUKYNDRA will be the first of what we anticipate will be a
continuous stream of biosimilar launches across a broad range of
therapeutic categories through our partnership with Alvotech.,”
said Peter Goldschmidt, CEO of STADA. “We are committed to working
with partners to bring competition to the biologic medicines
sector, thereby delivering value and facilitating patient
access.”
HUKYNDRA is the first of seven molecules covered by an exclusive
biosimilars agreement signed between Alvotech and STADA in November
2019. This broad partnership includes biosimilar candidates aimed
at treating autoimmunity, oncology, and ophthalmology
conditions.
In December 2021, the partners announced that they had received
approval from the European Commission for AVT02 (adalimumab), now
called HUKYNDRA in Europe, the company’s citrate-free, 100 mg/mL
high concentration biosimilar to Humira®, for the 27 member
countries of the European Union plus Norway, Iceland and
Liechtenstein.
HUKYNDRA is authorized for use in treating a range of
inflammatory conditions including rheumatoid arthritis, plaque
psoriasis and Crohn’s disease. Adalimumab inhibits tumor necrosis
factor alpha, which is a protein in the body involved in
inflammation. Humira® was the highest grossing medicine in the
world in 2021 (excluding COVID-19 vaccines) with global sales of
over $20 billion.
In February 2022, the US Food and Drug Administration (FDA)
accepted for review a Biologics License Application (BLA) for ATV02
(100 mg/mL), Alvotech’s citrate-free, high-concentration
biosimilar, that includes new data supporting interchangeability
between ATV02 and Humira®, for the U.S. market. The application was
supported by positive results from a switching study that
demonstrates bioequivalence and comparable efficacy, safety and
immunogenicity of repeated switches between administration of
Humira® and AVT02.
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, 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, asthma and
cancer. For more information, please visit www.alvotech.com.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany.
The company focuses on a three-pillar strategy consisting of
generics, specialty pharma and consumer healthcare products.
Worldwide, STADA Arzneimittel AG sells its products in
approximately 120 countries. In financial year 2021, STADA achieved
group sales of EUR 3,249.5 million and reported earnings before
interest, taxes, depreciation and amortization (EBITDA) of EUR
776.5 million. As of 31 December 2021, STADA employed 12,520 people
worldwide.
About AVT02
AVT02 is a monoclonal antibody and a biosimilar to Humira®
(adalimumab). AVT02 is not approved outside of the EU (Hukyndra®),
Canada (Simlandi™), and the United Kingdom (Hukyndra®). 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 for the fiscal year ended December 31,
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; (14) the commercial launch of AVT02 in Canada,
the United States, Europe or elsewhere; and (15) 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 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/20220406005081/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
STADA
Additional information for journalists: STADA
Arzneimittel AG - Media Relations Stadastrasse 2-18 61118 Bad
Vilbel - Germany Phone: +49 (0) 6101 603-165 Fax: +49 (0) 6101
603-215 E-Mail: press@stada.de Or visit us on the Internet at
www.stada.com/press
Additional information for capital market
participants:
STADA Arzneimittel AG - Investor & Creditor Relations
Stadastrasse 2-18 61118 Bad Vilbel – Germany Phone: +49 (0) 6101
603-4689 Fax: +49 (0) 6101 603-215 E-mail: ir@stada.de Or visit us
on the Internet at www.stada.com/investor-relations
OAKTREE ACQUISITION CORP. II
Investor Relations info@oaktreeacquisitioncorp.com
Media Relations mediainquiries@oaktreecapital.com
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