Israel’s Clal Biotechnology Industries has sold the exclusive worldwide commercialization rights for its cancer treatment pidilizumab to the American company Medivation. The rights are held by Clal subsidiary CureTech.
Pidilizumab (CT-011) is a humanized monoclonal antibody (mAb) that modulates the immune response and inhibits tumor growth and the spread of metastases.
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This is good news for Clal which is still embroiled in a scandal over accusations that its Andromeda Biotech unit faked the results of research on its drug for the treatment of diabetes. The company is currently being sued for $200 million by its former partner Hyperion because of it.
Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology.
Pidilizumab is a humanized monoclonal antibody which belongs to a class of anticancer therapies that target the immune system. Cancer cells evade destruction by suppressing immune T-lymphocytes through activation of the PD-1 (programmed death-1) pathway. Pidilizumab binds the PD-1 protein on T lymphocytes and facilitates the T-cells’ ability to target and destroy cancer cells.
“Immuno-oncology is a significant area of interest for researchers in the development of anti-cancer therapies, marked by its potential to stimulate the body’s immune system to fight disease, ” said David Hung, M.D., President and Chief Executive Officer of Medivation.
“We believe that Medivation’s expertise and accomplishments in drug development will be a tremendous advantage in the highly competitive field of oncology immunotherapy, ” said Michael Schickler, Chief Executive Officer of CureTech. “We are pleased that Medivation will advance this molecule to the next stage of development and potential commercialization.”
The arrangement also includes a manufacturing and supply agreement, under which CureTech will manufacture and supply the antibody to Medivation over the next 3 years for clinical development purposes. In addition, the arrangement contemplates a guaranty agreement between Medivation and CureTech’s largest (53%) shareholder — Clal Biotechnology Industries Ltd. (CBI) — with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders.
If approval of the guaranty agreement is not obtained, Medivation has the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms.
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel therapies to treat serious diseases for which there are limited treatment options. The company declares its aim to be to transform the treatment of these diseases and offer hope to critically ill patients and their families.
