Zymeworks Announces Expiration of Hart-Scott-Rodino Waiting Period for Zanidatamab License Agreement with Jazz Pharmaceuticals
29 Novembro 2022 - 10:30AM
Business Wire
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today announced
that the waiting period under the Hart-Scott-Rodino (HSR) Antitrust
Improvements Act of 1976, as amended, for the previously announced
license agreement of zanidatamab, a HER2-targeted bispecific
antibody, with Jazz Pharmaceuticals has expired.
The expiration or termination of the HSR waiting period was a
condition to Zymeworks’ receipt of a $50.0 million non-refundable
upfront payment from Jazz as part of the agreement. Zymeworks
anticipates providing Jazz top-line clinical data from Zymeworks’
HERIZON-BTC-01 study before the end of 2022. Should Jazz decide to
continue the collaboration following the data readout, a second,
one-time payment of $325.0 million to Zymeworks will be due and
payable, which Zymeworks expects to receive before the end of
2022.
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.
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; the anticipated benefits of the license agreement with
Jazz; 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; our and Jazz Pharmaceutical’s ability to obtain
regulatory approval of and successfully commercialize zanidatamab;
satisfaction of conditions under our agreement with Jazz; and other
information that is not historical information. When used herein,
words such as “subject to”, “believes”, “future”, “anticipate”,
“will”, “plans”, “may”, “potential”, “should”, “expects”, 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; 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221129005175/en/
Investor inquiries: Jack Spinks (604) 678-1388
ir@zymeworks.com Media inquiries: Diana Papove (604)
678-1388 media@zymeworks.com
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