Follows positive top-line clinical data
readout from HERIZON-BTC-01 pivotal trial in biliary tract
cancers
DUBLIN and VANCOUVER, BC, Dec. 21,
2022 /PRNewswire/ -- Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) and Zymeworks Inc. (Nasdaq: ZYME) today announced
that Jazz has exercised its option to continue with its exclusive
development and commercialization rights to Zymeworks' zanidatamab
in key markets, including the U.S., Europe and Japan, pursuant to the license and
collaboration agreement entered into in October 2022.
The decision to exercise this option follows positive top-line
clinical data from HERIZON-BTC-01, a pivotal trial in previously
treated HER2-amplified biliary tract cancers (BTC), which
demonstrated that 41.3% (95% CI: 30.4, 52.8) of enrolled patients
with HER2-amplified and expressing (IHC2+ and 3+) disease achieved
an objective response as assessed by independent central review.
The median duration of response was 12.9 months (95% CI: 5.95 to
not reached). The safety profile of zanidatamab in this trial was
consistent with that observed in previously reported monotherapy
studies, with no new safety signals identified.
"The compelling top-line clinical data from the pivotal trial in
patients with BTC highlight zanidatamab's potential to transform
the current standard of care," said Rob
Iannone, M.D., M.S.C.E., executive vice president, global
head of research and development of Jazz Pharmaceuticals. "This
important milestone strengthens our confidence in advancing this
therapy for cancer patients with significant unmet need. While our
initial focus will be on the ongoing clinical programs in BTC and
GEA, these data add to the growing body of evidence that
zanidatamab has anti-tumor activity across multiple
HER2-expressing cancers."
"We're pleased that our collaboration with Jazz is moving
forward, enabling the global, rapid advancement of zanidatamab in
multiple tumor types with the potential to provide a foundational
HER2-targeted therapy for patients with difficult-to-treat cancers
and limited treatment options," said Kenneth Galbraith, Chair & CEO of Zymeworks.
"Jazz's track record of R&D and commercial success, combined
with their deep relationships in the oncology community and shared
passion for working to improve outcomes for cancer patients, make
them the ideal development and commercialization partner for
zanidatamab."
Transaction Terms
Pursuant to the terms of the
agreement, Jazz will make a one-time payment of $325 million to Zymeworks, in the fourth quarter
of 2022, to exercise its option to continue with its 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. Jazz previously made a
separate $50 million up-front
payment. 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 of zanidatamab, Zymeworks is
eligible to receive tiered royalties between 10% and 20% on Jazz's
net sales.
MTS Health Partners, L.P. acted as exclusive financial advisor
and Wilson Sonsini Goodrich &
Rosati P.C. acted as legal advisor to Zymeworks in connection with
the license and collaboration agreement entered into in
October 2022.
About Zanidatamab
Zanidatamab is an investigational
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, along with collaborators Jazz and BeiGene,
are 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. Please visit www.jazzpharmaceuticals.com for more
information.
About Zymeworks Inc.
Zymeworks is a global
biotechnology company committed to the discovery, development, and
commercialization of novel, multifunctional biotherapeutics.
Zymeworks' mission is to make a meaningful difference for people
impacted by difficult-to-treat cancers and other diseases.
Zymeworks' complementary therapeutic platforms and fully integrated
drug development engine provide the flexibility and compatibility
to precisely engineer and develop highly differentiated
antibody-based therapeutic candidates. Zymeworks engineered and
developed zanidatamab, a HER2-targeted bispecific antibody using
Zymeworks' proprietary Azymetric™ technology. Zymeworks has entered
into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz
Pharmaceuticals Ireland Limited (Jazz), granting each of BeiGene
and Jazz with exclusive rights to develop and commercialize
zanidatamab in different territories. Zanidatamab is currently
being evaluated in global Phase 1, Phase 2, and pivotal clinical
trials as a treatment for patients with HER2-expressing cancers.
Zymeworks' next clinical candidate, zanidatamab zovodotin (ZW49),
is a HER2-targeted bispecific antibody-drug conjugate (ADC)
developed using Zymeworks' proprietary Azymetric™ and ZymeLink™
Auristatin technologies. Zanidatamab zovodotin is currently being
evaluated in a Phase 1 clinical trial for patients with a variety
of HER2-expressing cancers. Zymeworks is also advancing a deep
pipeline of product candidates based on its experience and
capabilities in both ADC and multispecific antibodies (MSAT). In
addition to Zymeworks' wholly-owned pipeline, its therapeutic
platforms have been further leveraged through strategic
partnerships with global biopharmaceutical companies. For
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
the release of top-line data from the ongoing pivotal Phase III
trial in GEA; zanidatamab's potential to transform the current
standard of care in multiple HER2-expressing cancers and its
potential in difficult-to-treat HER2-expressing cancers; 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
September 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 and Zymeworks' other product candidates; the
anticipated benefits of the license agreement with Jazz; Zymeworks'
ability to receive additional payments pursuant to the license
agreement, including any 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 Zymeworks' and
Jazz's ability to obtain regulatory approval of and successfully
commercialize zanidatamab; 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; 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; 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 September 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
1Valle 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.
2GBD 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.
3Galdy 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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SOURCE Jazz Pharmaceuticals plc