Jazz Pharmaceuticals has entered into a significant licensing agreement with Zymeworks Inc., securing exclusive development and commercialization rights to zanidatamab across major global markets, excluding certain Asia Pacific territories. The deal, which marks a substantial expansion of Jazz's oncology portfolio, could reach a total value of $1.76 billion plus royalties.
Under the terms of the agreement, Zymeworks will receive an initial upfront payment of $50 million, with a subsequent payment of $325 million at Jazz's discretion. The company stands to earn additional regulatory milestone payments of up to $525 million and commercial milestone payments reaching $862.5 million. Upon approval, Zymeworks will be eligible for tiered royalties ranging from 10% to 20% on Jazz's net sales.
Scientific Innovation in Cancer Treatment
Zanidatamab represents a significant advancement in HER2-targeted therapy. The bispecific antibody employs multiple novel mechanisms of action and has demonstrated compelling anti-tumor activity across various HER2-expressing cancers, both as a monotherapy and in combination with other treatments.
The drug's innovative design, based on Zymeworks' Azymetric platform, enables simultaneous binding to two non-overlapping HER2 epitopes through biparatopic binding. This unique approach results in dual HER2 signal blockade and removal of HER2 protein from the cell surface, leading to enhanced anti-tumor activity in patients.
Clinical Development Status and Regulatory Progress
The therapeutic candidate is currently undergoing pivotal trials in two key indications:
- Second-line treatment for HER2-expressing biliary tract cancer (BTC)
- First-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA)
Notably, zanidatamab has received FDA Breakthrough Therapy designation for BTC treatment in patients with HER2 gene-amplified disease who have received prior treatment. This designation is particularly significant as no HER2-targeted therapies are currently approved for BTC. Additionally, the FDA has granted Fast Track designations for zanidatamab both as a monotherapy for refractory BTC and in combination with standard chemotherapy for first-line GEA.
Strategic Implications and Future Outlook
Rob Iannone, MD, MSCE, Executive Vice President and Global Head of Research and Development at Jazz Pharmaceuticals, emphasized the strategic importance of the acquisition: "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."
The collaboration aligns with Jazz's Vision 2025 strategy, which aims to deliver at least five novel therapies to patients by the end of the decade. Kenneth Galbraith, Chair and CEO of Zymeworks, expressed enthusiasm about the partnership, highlighting Jazz's extensive oncology experience and shared commitment to improving cancer patient outcomes.
Top-line clinical data from the HERIZON-BTC-01 trial investigating zanidatamab in BTC is expected by year-end, potentially establishing a new foundation for HER2-targeted therapy in patients with limited treatment options. The transaction is anticipated to close within the 2022 calendar year, subject to regulatory approvals.
