Kamada slumps after Shire hands back rights
- Shire has halted the current U.S. Phase 2/3 study and ducked out of further trials of alpha-1 antitrypsin (G1-AAT IV), handing the investigational drug application for the Phase 2/3 for the treatment of acute graft-versus-host disease (GvHD) study back to Israeli developer Kamada.
- Shire previously headed up the development of G1-AAT-IV int he U.S., with Kamada responsible for Europe; Kamada now takes full responsibility and plans to begin studies again in "the upcoming few months" once it has standardized the study design across U.S. and European clinical development.
- The agreement between the two companies dates back to 2010, and Shire remains the exclusive distributor of the product in the U.S., Canada, Australia and New Zealand. Kamada and Shire will also continue to collaborate on the clinical development of G1-AAT-IV for prevention of lung transplantation rejection.
Since its acquisition of Baxalta in 2016, Shire has been shedding assets, for example terminating its biosimilars program and halting eight drug development programs. The downsizing of the G1-AAT-IV agreement, signed by Baxalta and Kamada in 2010, is just the latest casualty of the $700 million cost cutting that Shire plans to achieve by 2020.
Shire has blamed pipeline prioritization, as well as slow recruitment of patients to the U.S. study, for its decision to pull out of the GvHD clinical development of G1-AAT-IV. While Shire will retain distribution rights and R&D rights for the lung transplant indication, it will save on its R&D costs for this project going forward.
"Based on the FDA-approved IND in the U.S. and the guidance received at our scientific advice meeting held earlier this year with the EMA, we have a clear understanding of the regulatory path forward in both territories. Moreover, based on our GvHD industry expertise and discussions held with the key opinion leaders, from both territories... we believe that conducting an integrated clinical program across both territories will significantly benefit overall recruitment efforts, as well as provide important operational and financial efficiencies," said Kamada CEO Amir London.
Kamada shares had dipped by 6.7% by close of markets yesterday. The development does not bode well for the program. Generally the exit of a larger partner signals issues with the drug — in this case it could indicate a lack of market potential.
- Kamada Statement
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