Jazz to obtain exclusive development and
commercialization rights in key markets including the
U.S., Europe and Japan
Zymeworks to receive $50 million upfront payment, a second payment of
$325 million, at Jazz's option, and
further potential regulatory and commercial milestones for total
potential payments of up to $1.76
billion, plus royalties on net sales
Jazz continues to expand oncology portfolio
with novel late-stage asset with compelling anti-tumor
activity
Top-line clinical data for zanidatamab in
biliary tract cancer (HERIZON-BTC-01) expected by end of 2022;
potential to support first global regulatory filings
DUBLIN and VANCOUVER, Oct. 19,
2022 /CNW/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)
and Zymeworks Inc. (NYSE: ZYME) today announced that Jazz and
Zymeworks' subsidiary, Zymeworks BC Inc., have entered into an
exclusive licensing agreement under which Jazz will acquire
development and commercialization rights to Zymeworks' zanidatamab
across all indications in the United
States, Europe,
Japan and all other territories
except for those Asia/Pacific
territories previously licensed by Zymeworks.
"Zanidatamab is a novel HER2-targeted bispecific antibody with
biparatopic binding and the potential to transform the current
standard of care in multiple HER2 expressing cancers," said
Rob Iannone, M.D., M.S.C.E.,
executive vice president, global head of research and development
of Jazz Pharmaceuticals. "This agreement reflects Jazz's strategic
focus on opportunities where we can not only apply advanced
technologies to address critical unmet patient needs, but where we
can also leverage Jazz's existing integrated capabilities and
global infrastructure to commercialize efficiently. Zanidatamab has
the potential to deliver significant long-term value and
meaningfully contribute to Vision 2025 as we aim to deliver at
least five novel therapies to patients by the end of the decade. We
are pleased to expand our growing oncology pipeline with a
late-stage program, and today's announcement further demonstrates
our commitment to delivering novel oncology therapies."
"In partnering with Jazz, we are thrilled to be working with a
leading global biopharmaceutical team that brings a wealth of
development and commercial experience in oncology and shares our
vision and passion for working hard every day to improve outcomes
for cancer patients around the world," said Kenneth Galbraith, Chair & CEO of Zymeworks.
"Zymeworks and Jazz are committed to advancing the development of
zanidatamab as rapidly as possible, with the potential to provide a
foundational HER2-targeted therapy for patients with
difficult-to-treat cancers who currently have limited treatment
options."
Zanidatamab, a HER2-targeted bispecific antibody with novel
mechanisms of action, has demonstrated compelling anti-tumor
activity in several HER2-expressing cancers, both as monotherapy
and in combination with chemotherapy and other agents.
Zanidatamab is currently in pivotal trials as a second-line
treatment for HER2-expressing biliary tract cancer (BTC) and as a
first-line treatment for HER2-positive gastroesophageal
adenocarcinoma (GEA). In BTC, where no HER2-targeted therapies are
currently approved, the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy designation for zanidatamab,
positioning it as a potential first-in-class therapy. In GEA, based
on Phase 2 data, zanidatamab in combination with chemotherapy has
the potential to be a best-in-class therapy.
Zanidatamab is based on Zymeworks' Azymetric™ platform and can
simultaneously bind two non-overlapping epitopes of HER2, which is
known as biparatopic binding. This innovative design results in
multiple novel mechanisms of action including dual HER2 signal
blockade, enhanced binding and removal of HER2 protein from the
cell surface, and potent effector function leading to encouraging
antitumor activity in patients.
FDA has granted Breakthrough Therapy designation for zanidatamab
in patients with previously treated HER2 gene-amplified BTC, and
two Fast Track designations for zanidatamab, one as a single agent
for refractory BTC and one in combination with standard of care
chemotherapy, for first-line GEA. These designations mean
zanidatamab is eligible for Accelerated Approval, Priority Review
and Rolling Review, as well as FDA guidance on an efficient drug
development program. Zanidatamab has also received Orphan Drug
designations from FDA for the treatment of biliary tract and
gastric cancers, as well as Orphan Drug designation from the
European Medicines Agency for the treatment of gastric cancer.
Transaction Terms
Under the terms of the agreement, Jazz will receive an exclusive
license to develop and commercialize zanidatamab in
the United States, Europe, Japan
and all other territories except for those Asia/Pacific territories that Zymeworks
previously licensed to BeiGene, Ltd. Zymeworks is eligible to
receive a $50 million upfront
payment, following receipt of the clearance relating to the United
States Hart-Scott Rodino Antitrust Improvements Act of 1976 (such
clearance, the "HSR Clearance"), and should Jazz decide to continue
the collaboration following readout of the top-line clinical data
from HERIZON-BTC-01, a second, one-time payment of $325 million. Zymeworks is also eligible to
receive up to $525 million upon the
achievement of certain regulatory milestones and up to $862.5 million in potential commercial milestone
payments, for total potential payments of up to $1.76 billion. Pending approval, Zymeworks
is eligible to receive tiered royalties between 10% and 20% on
Jazz's net sales.
Closing of the agreement is subject to expiration or termination
of the waiting period under the Hart-Scott-Rodino Act of 1976. The
transaction is expected to close within the 2022 calendar year.
Zymeworks management will host a conference call and webcast for
investors and analysts on October 19,
2022, at 8:00 a.m. ET.
Interested parties should refer to the separate press release
issued by Zymeworks for additional details.
About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks'
Azymetric™ platform, that can simultaneously bind two
non-overlapping epitopes of HER2, known as biparatopic binding.
This unique design results in multiple mechanisms of action
including dual HER2 signal blockade, increased binding and removal
of HER2 protein from the cell surface, and potent effector function
leading to encouraging antitumor activity in patients. Zymeworks is
developing zanidatamab in multiple Phase 1, Phase 2 and pivotal
clinical trials globally as a targeted treatment option for
patients with solid tumors that express HER2.
About Biliary Tract
Cancers
Biliary tract cancers (BTC), including gallbladder cancer and
cholangiocarcinoma, account for approximately 3% of all adult
cancers and are often associated with a poor
prognosis1. Globally, more than 210,000
people are diagnosed with BTC every
year2 and most patients (> 65%) are
diagnosed with tumors that cannot be removed surgically. The human
epidermal growth factor receptor 2 (HER2) is a well-validated
target for anti-cancer therapy. About 5% to 19% of patients with
BTC have tumors that express HER23 and
may be positioned for potential benefit from HER2-targeted therapy.
Currently no HER2-targeted therapy has been approved for the
treatment of BTC.
About Gastroesophageal
Adenocarcinoma
Gastroesophageal adenocarcinoma (GEA) is the fifth most common
cancer worldwide and approximately 20% of patients are
HER2–positive. HER2–positive GEA has high morbidity and mortality,
and patients are urgently in need of new treatment options.
About Jazz Pharmaceuticals
plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
– often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology.
Within these therapeutic areas, we are identifying new options for
patients by actively exploring small molecules and biologics, and
through innovative delivery technologies and cannabinoid science.
Jazz is headquartered in Dublin,
Ireland and has employees around the globe, serving patients
in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the discovery, development and commercialization of
next-generation multifunctional biotherapeutics. Zymeworks' suite
of therapeutic platforms and its fully integrated drug development
engine enable precise engineering of highly differentiated product
candidates. Zymeworks' lead clinical candidate, zanidatamab, is a
novel Azymetric™ HER2-targeted bispecific antibody currently being
evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials
globally as a targeted treatment option for patients with solid
tumors that express HER2. Zymeworks' second clinical candidate,
zanidatamab zovodotin (ZW49), is a novel bispecific HER2 –targeted
antibody-drug conjugate currently in Phase 1 clinical development
and combines the unique design and antibody framework of
zanidatamab with Zymeworks' proprietary ZymeLink™ linker and
cytotoxin. Zymeworks is also advancing a deep preclinical
pipeline in oncology (including immuno-oncology agents) and other
therapeutic areas. In addition, its therapeutic platforms are being
leveraged through strategic partnerships with global
biopharmaceutical companies. For more information on our ongoing
clinical trials visit www.zymeworksclinicaltrials.com. For
additional information about Zymeworks,
visit www.zymeworks.com and
follow @ZymeworksInc on Twitter.
Jazz Pharmaceuticals plc Caution
Concerning Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to zanidatamab's
potential to be a best-in-class therapy in GEA and potential
first-in-class therapy in BTC; zanidatamab's potential to deliver
significant long-term value and meaningfully contribute to Vision
2025; the potential future development, manufacturing, regulatory
and commercialization activities; potential future payments by Jazz
Pharmaceuticals to Zymeworks for development, regulatory and
commercial milestones as well as tiered royalties based on future
net sales; and other statements that are not historical facts.
These forward-looking statements are based on Jazz Pharmaceuticals'
current plans, objectives, estimates, expectations and intentions
and inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties associated with: Jazz Pharmaceuticals' ability to
achieve the expected benefits (commercial or otherwise) from the
license agreement; pharmaceutical product development and clinical
success thereof; the regulatory approval process; effectively
commercializing any product candidates; and other risks and
uncertainties affecting Jazz Pharmaceuticals, including those
described from time to time under the caption "Risk Factors" and
elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange
Commission filings and reports (Commission
File No. 001-33500), including Jazz Pharmaceuticals'
Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022 and future filings and
reports by Jazz Pharmaceuticals. Other risks and uncertainties of
which Jazz Pharmaceuticals is not currently aware may also affect
Jazz Pharmaceuticals' forward-looking statements and may cause
actual results and the timing of events to differ materially from
those anticipated. The forward-looking statements herein are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by Jazz Pharmaceuticals on its website or otherwise. Jazz
Pharmaceuticals undertakes no obligation to update or supplement
any forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
Zymeworks Cautionary Note
Regarding Forward-Looking Statements
This press release includes "forward-looking statements" or
information within the meaning of the applicable securities
legislation, including Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements in this press release
include, but are not limited to, statements that relate to the
potential therapeutic effects and commercial potential of
zanidatamab, zanidatamab zovodotin and Zymeworks' other product
candidates; the anticipated benefits of the license agreement with
Jazz; Zymeworks' ability to receive the upfront $50 million payment following expiration or
termination of the waiting period under the Hart-Scott-Rodino Act
and the anticipated timing thereof; Zymeworks' ability to receive
additional payments pursuant to the license agreement, including
the additional $325 million following
readout of the top-line clinical data from HERIZON-BTC-01, as
well as any additional future milestone payments and royalties; the
timing of and results of the interactions with regulators; the
timing and status of ongoing and future studies and the related
data; the commercial potential of zanidatamab and our and Jazz
Pharmaceutical's ability to obtain regulatory approval of and
successfully commercialize zanidatamab the anticipated timing
of closing of our agreement with Jazz Pharmaceuticals and
satisfactions of closing conditions; and other information
that is not historical information. When used herein, words such as
"subject to", "believes", "future", "anticipate", "approximately",
"will", "plans", "may", "potential", and similar expressions are
intended to identify forward-looking statements. In addition, any
statements or information that refer to expectations, beliefs,
plans, projections, objectives, performance or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking. All forward-looking
statements are based upon Zymeworks' current expectations and
various assumptions. Zymeworks believes there is a reasonable basis
for its expectations and beliefs, but they are inherently
uncertain. Zymeworks may not realize its expectations, and its
beliefs may not prove correct. Actual results could differ
materially from those described or implied by such forward-looking
statements as a result of various factors, including, without
limitation: any of Zymeworks' or its partners' product candidates
may fail in development, may not receive required regulatory
approvals, or may be delayed to a point where they are not
commercially viable; Zymeworks may not achieve milestones or
receive additional payments under its collaborations, including the
anticipated upfront payments from Zymeworks' agreement with Jazz;
expiration or termination of the waiting period under the
Hart-Scott-Rodino Act may be delayed or may not be received at all;
regulatory agencies may impose additional requirements or delay the
initiation of clinical trials; the impact of new or changing laws
and regulations; market conditions; the impact of the COVID-19
pandemic on Zymeworks' business, research and clinical development
plans and timelines and results of operations, including impact on
its clinical trial sites, collaborators, and contractors who act
for or on Zymeworks' behalf, may be more severe and more prolonged
than currently anticipated; clinical trials may not demonstrate
safety and efficacy of any of Zymeworks' or its collaborators'
product candidates; any of Zymeworks' or its partners' product
candidates; Jazz may decide not to proceed with the
collaboration following readout of the top-line clinical data from
HERIZON-BTC-01; Zymeworks may be unable to maintain or enter into
new partnerships or strategic collaborations and the factors
described under "Risk Factors" in Zymeworks' quarterly and annual
reports filed with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for its quarter ended
June 30, 2022 (a copy of which may be
obtained at www.sec.gov and www.sedar.com).
Although Zymeworks believes that such forward-looking statements
are reasonable, there can be no assurance they will prove to be
correct. Investors should not place undue reliance on
forward-looking statements. The above assumptions, risks and
uncertainties are not exhaustive. Forward-looking statements are
made as of the date hereof and, except as may be required by law,
Zymeworks undertakes no obligation to update, republish, or revise
any forward-looking statements to reflect new information, future
events or circumstances or to reflect the occurrences of
unanticipated events.
Jazz Media Contact:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637
2141
U.S. +1 215 867 4948
Jazz Investor Contact:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland, +353 1 634
3211
U.S. +1 650 496 2717
Zymeworks Media Contact:
Diana Papove
Senior Manager, Corporate Communications
media@zymeworks.com
(604) 678-1388
Zymeworks Investor Contact:
Jack Spinks
Associate Director, Investor Relations
ir@zymeworks.com
(604) 678-1388
1 Valle JW, Lamarca A, Goyal L, Barriuso J, Zhu
AX. New Horizons for precision medicine in biliary tract cancers.
Cancer Discov. 2017;7(9):943-962.
2 GBD 2017 Disease and Injury Incidence and
Prevalence Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 354 diseases and
injuries for 195 countries and territories, 1990-2017: a systematic
analysis for the Global Burden of Disease Study 2017. Lancet.
2018;392(10159):1789-1858.
3 Galdy S, Lamarca A, McNamara MG, et al.
HER2/HER3 pathway in biliary tract malignancies; systematic review
and meta-analysis: a potential therapeutic target? Cancer
Metastasis Rev. 2017;36(1):141-157.
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