Under the terms of the deal, Jazz will obtain exclusive rights to develop and commercialise zanidatamab worldwide, excluding certain Asia-Pacific territories those Zymeworks has previously licensed to BeiGene
Jazz signs exclusive licence deal with Zymeworks. (Credit: Markus Spiske on Unsplash)
Jazz Pharmaceuticals has signed a licensing deal with a subsidiary of Canadian biotechnology company Zymeworks for the latter’s cancer drug zanidatamab.
Under the terms of the deal, Jazz will obtain exclusive rights to develop and commercialise zanidatamab worldwide, excluding certain Asia-Pacific territories those Zymeworks has previously licensed to BeiGene.
The Irish biopharmaceutical company will make an upfront payment of $50m to Zymeworks, after receiving the clearance relating to the US Hart-Scott Rodino Act.
It will also make a second, one-time payment of $325m if it wishes to continue the collaboration following the release of clinical data from HERIZON-BTC-01.
Zymeworks is eligible to receive up to $525m upon achieving certain regulatory milestones and up to $862.5m in potential commercial milestone payments.
In addition, the company is eligible to receive tiered royalties between 10% and 20% on Jazz’s net sales, pending regulatory approval.
The transaction is expected to be completed within this calendar year, subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Act of 1976.
Jazz Pharmaceuticals executive vice president and research and development global head Rob Iannone said: “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.
“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 commercialise efficiently.
“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.”
Zanidatamab is a bispecific antibody, developed based on Zymeworks’ Azymetric platform, which enables simultaneous binding of two non-overlapping epitopes of HER2
The company is developing the HER2-targeted bispecific antibody in multiple Phase 1, Phase 2 and pivotal clinical studies worldwide, in patients with HER2-positive solid tumours.
It works with multiple mechanisms of action, including dual HER2 signal blockade, increased binding and removal of HER2 protein, and potent effector function.
The drug showed superior anti-tumour activity in several HER2-expressing cancers, both as monotherapy and in combination with chemotherapy and other agents.
It has received the US Food and Drug Administration (FDA) Breakthrough Therapy designation to treat biliary tract cancer (BTC), along with two Fast Track designations.
Furthermore, the drug has also secured the FDA Orphan Drug designation in biliary tract and gastric cancers, and the Orphan Drug designation from the European Medicines Agency.
Zymeworks chair and CEO Kenneth Galbraith said: “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.
“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.”