Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a Japan-based
global specialty pharmaceutical company (J-GSP) creating innovative
medical solutions utilizing the latest biotechnology, and Orchard
Therapeutics plc (Orchard Therapeutics, Nasdaq: ORTX), a global
gene therapy leader, today announced the companies have entered
into a definitive agreement under which Kyowa Kirin will acquire
Orchard Therapeutics for $16.00 per American Depositary Share (ADS)
in cash (approximately $387.4 million, or ¥57.3 billion), under
which Orchard shareholders will hold an additional contingent value
right (CVR) of $1.00 per ADS. An additional $1.00 CVR will be paid
for a total of $17.00 per ADS, or approximately $477.6 million
(¥70.7 billion) if the conditions are met.
Kyowa Kirin has established a 2030 Vision to consistently create
and deliver medicines with life-changing value that ultimately
makes people smile, as a J-GSP. At the core of this strategy is a
commitment to life, and a desire to match transformative science to
areas of great unmet need. Kyowa Kirin believes the potential of
cell and gene therapies to help patients aligns well with its
Vision, patient commitment, and emerging expertise in
commercializing rare disease medicines worldwide.
The gene therapy approach pioneered by Orchard Therapeutics
harnesses the unique power of a patient’s own genetically modified
hematopoietic stem cells (HSCs) to potentially correct the
underlying cause of a genetic disease using a single
administration. Upon closing, the acquisition would provide Kyowa
Kirin with a global leadership position in the burgeoning field of
genetic medicine, including a portfolio spanning commercial,
clinical, and pre-clinical HSC gene therapies designed to address
serious diseases where the burden is immense for patients, families
and society and current treatment options are limited or do not
exist.
Orchard Therapeutics’ portfolio comprises Libmeldy®
(atidarsagene autotemcel), also known as OTL-200, intended for
eligible patients with early-onset metachromatic leukodystrophy
(MLD), a rare and life-threatening inherited disease of the body’s
metabolic system. In the most severe form of MLD, babies develop
normally but in late infancy start to rapidly lose the ability to
walk, talk and interact with the world around them. Libmeldy is
approved by the European Commission (EC) and UK Medicines and
Healthcare products Regulatory Agency (MHRA) for the treatment of
“late infantile” and “early juvenile” MLD patients. It is currently
an investigational drug under Priority Review by the Food and Drug
Administration (FDA) with a Prescription Drug User Fee Act (PDUFA)
goal date of March 18, 2024.
Using the same HSC gene therapy technology platform, Orchard
Therapeutics is progressing two clinical-stage programs known as
OTL-203 and OTL-201 for the treatment of another group of severe
pediatric neurometabolic disorders, mucopolysaccharidosis type I
Hurler’s syndrome (MPS-IH) and mucopolysaccharidosis type IIIA
(MPS-IIIA), also known as Sanfilippo syndrome, respectively.
This acquisition will allow Kyowa Kirin to maximize the value of
Libmeldy® and efficiently accelerate the development of Orchard
Therapeutics’ next-in-line MPS programs, as well as its other early
research programs, including a severe, genetic form of Crohn’s
disease and frontotemporal dementia (FTD). Furthermore, the
combination of Orchard Therapeutics' innovative HSC gene therapy
platform technology and Kyowa Kirin's capabilities, resources and
infrastructure will enable the continued development of numerous
promising biopharmaceutical candidates with the potential to
deliver life-changing value in medical care, including in
therapeutic areas and indications where Kyowa Kirin has deep
experience, such as oncology and autoimmune diseases.
“We are excited to announce that we have signed the Transaction
Agreement to acquire Orchard Therapeutics, one of the leading
providers of HSC gene therapy,” said Takeyoshi Yamashita, Ph.D.,
Director of the Board, chief medical officer, senior managing
executive officer of Kyowa Kirin. “With this transaction, we
anticipate being able to use a new modality that can have a
profound impact on patients' lives. Orchard Therapeutics is a
company with a steady track record in this field and has already
launched its HSC gene therapy in Europe and filed for review in the
U.S. Our hope is to combine the strengths of Kyowa Kirin and
Orchard Therapeutics with mutual respect to realize the successful
creation and delivery of life-changing value for patients living
with rare and life-threatening inherited diseases.”
“This is an exciting opportunity designed to accelerate the
realization of our shared vision of ending the devastation caused
by severe genetic diseases and deliver life-changing value in
medical care,” said Bobby Gaspar, co-founder and chief executive
officer of Orchard Therapeutics. “We remain as true to our mission
as ever, and joining Kyowa Kirin’s global network ensures we are
well-resourced to progress anticipated commercialization of OTL-200
in the U.S., if approved, continue investing in initiatives aimed
at accelerating Libmeldy growth in Europe, capitalize on
opportunities for global expansion, as well as advance our
next-in-line neurometabolic programs in MPS disorders and
earlier-stage research programs. We look forward to collaborating
with our new colleagues at Kyowa Kirin to fully unlock the curative
potential of HSC gene therapy for the benefit of patients and
society.”
Kyowa Kirin will hold a conference for investors on October 5 at
18:30 p.m. JST.
Outline of the transactionUnder the terms of
the agreement, Kyowa Kirin will initiate a scheme of arrangement to
acquire all Orchard Therapeutics’ ADSs at a price of $16.00 per ADS
in cash (or aggregated value of approximately $387.4 million, or
approximately ¥57.3 billion) at closing, which represents a premium
of 144% to Orchard Therapeutics’ volume-weighted average price per
ADS over the previous 30 days ended October 4.
In connection with the transaction, a non-transferable CVR will
be distributed to Orchard Therapeutics shareholders. Holders of the
CVR will be entitled to receive a cash payment of $1.00 per ADS
related to the approval of OTL-200 for the treatment of MLD in the
U.S. as defined in the CVR Agreement.
Warrants outstanding as of the date of the Transaction Agreement
will continue to be satisfied in accordance with their terms.
The transaction has been unanimously approved by both company’s
Board of Directors and is expected to close in the first quarter of
2024 subject to Orchard Therapeutics’ shareholder approval, receipt
of applicable regulatory approvals and other customary closing
conditions.
Following the completion of the acquisition, Orchard
Therapeutics will become a wholly-owned subsidiary of Kyowa
Kirin.
Kyowa Kirin is represented by Goldman Sachs Japan Co., Ltd. as
financial advisor and Morrison & Foerster LLP. as legal
advisor. Orchard Therapeutics is represented by Guggenheim
Securities, LLC as financial advisor, Goodwin Procter LLP as U.S.
legal advisor, and Slaughter & May Ltd. as UK legal
advisor.
Overview of Orchard Therapeutics
(1) |
|
Name |
Orchard Therapeutics plc |
(2) |
|
Location |
245 Hammersmith Road, 3rd Floor London W6 8PW UnitedKingdom |
(3) |
|
Job title and name ofrepresentative |
Chief Executive OfficerBobby Gaspar |
(4) |
|
Description of business |
Development and commercialization of hematopoietic stemcell gene
therapy |
(5) |
|
Share capital |
$29,456 thousand (as of June 30, 2023) |
(6) |
|
Date of establishment |
2015 |
(7) |
|
Major shareholdersand ownership ratios |
RA Capital Management, LP (25.7%)Deep Track Capital LP
(9.0%)Zentree Investment Management Pte Ltd (8.3%)(as of June 30,
2023) |
(8) |
|
Relationship betweenKyowa Kirin andOrchard |
Capital relationship |
None |
Personnel relationship |
None |
Business relationship |
None |
Related Party Status |
None |
About Kyowa KirinKyowa Kirin strives to create
and deliver novel medicines with life-changing value. As a
Japan-based Global Specialty Pharmaceutical Company with a heritage
of 70+ years, we apply cutting-edge science including an expertise
in antibody research and engineering, to address the needs of
patients and society across multiple therapeutic areas including
Nephrology, Oncology, Immunology/Allergy and Neurology. Across our
four regions – Japan, Asia Pacific, North America and
EMEA/International – we focus on our purpose, to make people smile,
and are united by our shared values of commitment to life,
teamwork/Wa, innovation, and integrity. You can learn more about
the business of Kyowa Kirin at: https://www.kyowakirin.com.
About Orchard TherapeuticsAt Orchard
Therapeutics, our vision is to end the devastation caused by
genetic and other severe diseases. We aim to do this by
discovering, developing and commercializing new treatments that tap
into the curative potential of hematopoietic stem cell (HSC) gene
therapy. In this approach, a patient’s own blood stem cells are
genetically modified outside of the body and then reinserted, with
the goal of correcting the underlying cause of disease in a single
treatment.
In 2018, the company acquired GSK’s rare disease gene therapy
portfolio, which originated from a pioneering collaboration between
GSK and the San Raffaele Telethon Institute for Gene Therapy in
Milan, Italy. Today, Orchard is advancing a pipeline spanning
pre-clinical, clinical and commercial stage HSC gene therapies
designed to address serious diseases where the burden is immense
for patients, families and society and current treatment options
are limited or do not exist.
Orchard has its global headquarters
in London and U.S. headquarters in Boston. For
more information, please visit www.orchard-tx.com, and follow
us on X (Twitter) and LinkedIn.
About Libmeldy / OTL-200Libmeldy® (atidarsagene
autotemcel), also known as OTL-200, has been approved by the
European Commission for the treatment of metachromatic
leukodystrophy (MLD) in patients characterized by biallelic
mutations in the ARSA gene leading to a reduction of the ARSA
enzymatic activity in children with i) late infantile or early
juvenile forms, without clinical manifestations of the disease, or
ii) the early juvenile form, with early clinical manifestations of
the disease, who still have the ability to walk independently and
before the onset of cognitive decline. Libmeldy is the first
therapy approved for eligible patients with early-onset MLD.
The most common adverse reaction attributed to treatment with
Libmeldy was the occurrence of anti-ARSA antibodies. In addition to
the risks associated with the gene therapy, treatment with Libmeldy
is preceded by other medical interventions, namely bone marrow
harvest or peripheral blood mobilization and apheresis, followed by
myeloablative conditioning, which carry their own risks. During the
clinical studies of Libmeldy, the safety profiles of these
interventions were consistent with their known safety and
tolerability.
For more information about Libmeldy, please see the Summary of
Product Characteristics (SmPC) available on the EMA website.
Libmeldy is approved in the European Union, UK, Iceland,
Liechtenstein and Norway. OTL-200 is an investigational therapy in
the U.S.
Libmeldy was developed in partnership with the San
Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan,
Italy.
Additional Information and Where to Find It In
connection with the proposed transaction between Kyowa Kirin Co.,
Ltd. (“Kyowa Kirin”) and Orchard Therapeutics plc (“Orchard”),
Orchard intends to file with the Securities and Exchange Commission
(the “SEC”) a Proxy Statement, the definitive version of which (if
and when available) will be mailed to Orchard security holders.
Orchard may also file other documents with the SEC regarding the
proposed transaction. This document is not a substitute for the
Proxy Statement or any other document which Orchard may file with
the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY
STATEMENT (WHICH WILL INCLUDE AN EXPLANATORY STATEMENT IN RESPECT
OF THE SCHEME OF ARRANGEMENT OF ORCHARD, IN ACCORDANCE WITH THE
REQUIREMENTS OF THE U.K. COMPANIES ACT 2006) AND ANY OTHER RELEVANT
DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS
ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN
THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY
CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION AND RELATED MATTERS. Investors and security holders may
obtain a free copy of the Proxy Statement and other relevant
documents containing important information about Kyowa Kirin,
Orchard and the proposed transaction (if and when they become
available) once such documents are filed with the SEC at the SEC’s
website at www.sec.gov. Copies of the documents filed with the SEC
by Orchard will be available free of charge on Orchard's website at
ir.orchard-tx.com or by contacting Orchard’s Investor Relations
Department at investors@orchard-tx.com.
Participants in the Solicitation Orchard and
certain of its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the
proposed transaction. Information regarding Orchard’s directors and
executive officers, including a description of their direct
interests, by security holdings or otherwise, is contained in
Orchard’s proxy statement for its 2023 annual general meeting of
shareholders, which was filed with the SEC on April 27, 2023, and
subsequent statements of beneficial ownership on file with the SEC.
Orchard shareholders may obtain additional information regarding
the direct and indirect interests of the participants in the
solicitation of proxies in connection with the proposed
transaction, including the interests of Orchard directors and
executive officers in the transaction, which may be different than
those of Orchard shareholders generally, by reading the Proxy
Statement if and when it is filed with the SEC and any other
relevant documents that are filed or will be filed with the SEC
relating to the transaction. You may obtain free copies of these
documents using the sources indicated above.
Cautionary Statement Regarding Forward-Looking
Statements This communication contains “forward-looking
statements” within the meaning of the federal securities laws,
including Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Exchange Act. These forward-looking
statements are based on Orchard’s current expectations, estimates
and projections about the expected date of closing of the proposed
transaction and the potential benefits thereof, its business and
industry, management’s beliefs and certain assumptions made by
Orchard and Kyowa Kirin, all of which are subject to change. In
this context, forward-looking statements often address expected
future business and financial performance and financial condition,
and often contain words such as “expect,” “anticipate,” “intend,”
“plan,” “believe,” “could,” “seek,” “see,” “will,” “may,” “would,”
“might,” “potentially,” “estimate,” “continue,” “expect,” “target,”
“explore,” “evaluate,” “predict,” “project,” similar expressions or
the negatives of these words or other comparable terminology that
convey uncertainty of future events or outcomes. All
forward-looking statements by their nature address matters that
involve risks and uncertainties, many of which are beyond Orchard’s
or Kyowa Kirin’s control, and are not guarantees of future results,
such as statements about the consummation of the proposed
transaction and the anticipated benefits thereof. These and other
forward-looking statements, are not guarantees of future results
and are inherently subject to risks, uncertainties and assumptions
that could cause actual results to differ materially from those
expressed in any forward-looking statements. Accordingly, there are
or will be important factors that could cause actual results to
differ materially from those indicated in such statements and,
therefore, you should not place undue reliance on any such
statements and caution must be exercised in relying on
forward-looking statements. Important risk factors and
uncertainties that may cause such a difference include, but are not
limited to, risks and uncertainties surrounding: (i) the completion
of the proposed transaction on anticipated terms and timing,
including in connection with obtaining shareholder and regulatory
approvals, the sanction of the High Court of Justice of England and
Wales, satisfaction of other closing conditions to consummate the
acquisition, anticipated tax treatment, unforeseen liabilities,
future capital expenditures, revenues, expenses, earnings,
synergies, economic performance, indebtedness, financial condition,
losses, future prospects, business and management strategies for
the management, expansion and growth of Orchard’s business and
other conditions to the completion of the transaction; (ii) the
occurrence of any event, change or other circumstance that could
give rise to the termination of the definitive transaction
agreement relating to the proposed transaction; (iii) Orchard’s
ability to implement its business model and strategic plans for its
product, product candidates and pipeline, and challenges inherent
in developing, commercializing, manufacturing, launching, marketing
and selling existing and new products; (iv) significant transaction
costs associated with the proposed transaction; (v) potential
litigation relating to the proposed transaction; (vi) the risk that
disruptions from the proposed transaction will harm Orchard’s
business, including current plans, operations and collaborations,
and including as a result of diverting the attention of Orchard’s
and Kyowa Kirin’s management from ongoing business operations;
(vii) the ability of Orchard to retain and hire key personnel;
(viii) potential adverse reactions or changes to business
relationships resulting from the announcement or completion of the
proposed transaction; (ix) legislative, regulatory and economic
developments affecting Orchard’s business; (x) general economic and
market developments and conditions; (xi) the evolving legal,
regulatory and tax regimes under which Orchard operates; (xii)
potential business uncertainty, including changes to existing
business relationships, during the pendency of the transaction that
could affect Orchard’s financial performance; (xiii) restrictions
during the pendency of the proposed transaction that may impact
Orchard’s ability to pursue certain business opportunities or
strategic transactions; (xiv) the risk that Orchard may be unable
to obtain governmental and regulatory approvals required for the
proposed transaction, or that required governmental and regulatory
approvals may delay the consummation of the proposed transaction or
result in the imposition of conditions that could reduce the
anticipated benefits from the proposed transaction or cause the
parties to abandon the proposed transaction; (xv) unpredictability
and severity of catastrophic events, including, but not limited to,
global pandemic, acts of terrorism or outbreak of war or
hostilities, as well as Orchard’s response to any of the
aforementioned factors; (xvi) potential delays or failures related
to research, clinical trials and/or development of Orchard’s
programs or product candidates, which are based on novel gene
therapy and (xvii) the risks related to non-achievement of the CVR
milestone and that holders of the CVRs will not receive payments in
respect of the CVRs. Additional factors that may affect the future
results of Orchard are set forth in Orchard’s filings with the SEC,
including Orchard’s most recently filed Annual Report on Form 10-K,
subsequent Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other filings with the SEC, which are available on the
SEC’s website at www.sec.gov. See in particular Item 1A of
Orchard’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022, and Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 2023, under the headings “Risk
Factors.” The risks and uncertainties described above and in the
SEC filings cited above are not exclusive and further information
concerning Orchard and its business, including factors that
potentially could materially affect Orchard’s business, financial
conditions or operating results, may emerge from time to time.
Moreover, other risks and uncertainties of which Orchard is not
currently aware may also affect Orchard’s forward-looking
statements and may cause actual results and the timing of events to
differ materially from those anticipated. Readers are urged to
consider these factors carefully in evaluating these
forward-looking statements, and not to place undue reliance on any
forward-looking statements, which speak only as of the date hereof
and reflect the views stated therein with respect to future events
as at such dates, even if they are subsequently made available by
Orchard on its website or otherwise. Readers should also carefully
review the risk factors described in other documents that Orchard
files from time to time with the SEC. Except as required by law,
Orchard assumes no obligation to update or revise these
forward-looking statements for any reason, even if new information
becomes available in the future.
No Offer or SolicitationThis communication is
not intended to and shall not constitute an offer to buy or sell or
the solicitation of an offer to buy or sell any securities, or a
solicitation of any vote or approval, nor shall there be any offer,
solicitation or sale of securities in any jurisdiction in which
such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offer of securities shall be made in the United
States absent registration under the U.S. Securities Act of 1933,
as amended, or pursuant to an exemption from, or in a transaction
not subject to, such registration requirements.
CONTACTS:
For Kyowa Kirin
Hiroki Nakamura: Global/Japan
Corporate Communications Department
media@kyowakirin.com
Lisa Popyk: North America
Corporate Communications – Kyowa Kirin North America
lisa.popyk.3z@kyowakirin.com
Stacey Minton: EMEA
SVP, Corporate Affairs – Kyowa Kirin International
Stacey.Minton@kyowakirin.com
For Orchard Therapeutics
Benjamin Navon
+1 857-248-9454
Benjamin.Navon@orchard-tx.com
Orchard Therapeutics (NASDAQ:ORTX)
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Orchard Therapeutics (NASDAQ:ORTX)
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