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On October 19, Jazz Pharmaceuticals plc (NASDAQ: Jazz) and Zymeworks Inc.
(NYSE: ZYME) announced that Jazz and Zymewarks BC Inc.
, a subsidiary of Zymeworks, have entered into an exclusive license agreement under which Jazz will acquire Zymeworks' zanidatamab in the United States, Europe and Canada.
Development and commercialization rights for all indications in Japan and all other regions, except
for the Asia Pacific region previously licensed to BeiGene by Zymeworks.
Zymeworks is eligible for an upfront payment of $50 million, a second one-time payment of $325 million
if Jazz decides to continue working together following the release of top-tier clinical data for HERIZON-BTC-01.
Zymeworks is also eligible for up to $525 million after achieving certain regulatory milestones, as well as potential commercial milestone payments of up to $862.
5 million, with potential payments daring to reach $1.
76 billion
.
Pending approval, Zymeworks is eligible for graded royalties
of 10% to 20% from Jazz's net sales.
Dr.
Rob Iannone, Executive Vice President and Global Director of R&D at Jazz Pharmaceuticals, said: "Zanidatamab is a novel HER2-targeted, bispecific antibody with biparatopic binding that has the potential to change the current standard of care for
multiple HER2-expressing cancers 。 This agreement reflects Jazz's strategic focus on opportunities where we can not only apply advanced technologies to meet critical unmet patient needs, but also leverage Jazz's existing integration capabilities and global infrastructure for efficient commercialization
.
Zanidatamab has the potential to deliver tremendous long-term value and aims to make a meaningful contribution to Vision 2025 with the goal of making at least five new therapies
available to patients by the end of the decade.
We are excited to expand our growing oncology pipeline through late-stage programs, and today's announcement is further proof of our commitment to
delivering novel oncology therapies.
" ”
Rob Iannone, Executive Vice President and Global Director of Research and Development at Jazz Pharmaceuticals, said:
Kenneth Galbraith, Chairman and CEO of Zymeworks, said: "Through our partnership with Jazz, we are excited to partner with the world's leading biopharmaceutical team, which brings extensive development and commercial experience in oncology and shares the vision and passion we work hard every day to improve outcomes
for cancer patients around the world.
Zymeworks and Jazz are committed to advancing the development of Zanidatamab as quickly as possible to provide foundational HER2-targeted therapies
for patients with refractory cancers with limited treatment options today.
”
Zanidatamab, a HER2-targeted, bispecific antibody with a novel mechanism of action, has shown convincing antitumor activity in several HER2-expressing cancers, both as monotherapy and in combination with chemotherapy and other drugs
.
Zanidatamab is currently being pivotal trial
as a second-line treatment for HER2-expressing biliary tract cancer (BTC) and HER2-positive gastroesophageal adenocarcinoma (GEA).
Among BTC that has not yet approved HER2-targeted therapy, the U.
S.
FDA has granted Zanidatamab breakthrough therapy designation, positioning it as a potentially first-class treatment
.
In GEA, Zanidatamab combined with chemotherapy has the potential to become a first-class treatment
based on Phase 2 clinical data.
Zanidatamab is based on Zymeworks' Azmetric™ and can bind two nonoverlapping epitopes of HER2 simultaneously, which is known as biparasitic binding
.
This innovative design has led to multiple new mechanisms of action, including dual HER2 signal blocking, enhanced binding and removal of HER2 proteins from the cell surface, and effective effector function to promote anti-tumor activity
in patients.
The FDA has granted Zanidatamab breakthrough therapy designations to patients who have previously treated HER2 gene amplified BTC and two fast-track designations for Zanidatamab, one as a single agent for refractory BTC and the other in combination with standard-care chemotherapy for first-line GEA
.
These designations mean that Zanidatamab is eligible for accelerated approval, priority review and rolling review, as well as FDA guidance
on effective drug development programs.
Zanidatamab has also received FDA orphan drug designation for the treatment of biliary tract and stomach cancer, as well as the European Medicines Agency's orphan drug designation
for the treatment of stomach cancer.
