Date: 2014-10-23
Type of information: Exercise of an option agreement
Compound: pidilizumab (CT-011)
Company: Curetech (Israel) Medivation (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: monoclonal antibody. 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.
Disease: hematological malignancies and solid tumors
Details: * On December 22, 2014, Medivation announced that it has exercised its option under the terms of the license agreement announced on October 23, 2014, for pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody from CureTech. Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology. The agreement includes a guaranty with respect to certain obligations of CureTech by Clal Biotechnology Industries Ltd. (CBI), CureTech's largest (53%) shareholder. The guaranty has been approved by CBI shareholders. Under the terms of the license agreement, CureTech will receive an upfront payment of $5.0 million from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling up to $85 million. In addition, CureTech would be eligible to receive sales-based milestone payments totaling up to $245 million upon the achievement of certain annual worldwide net sales thresholds and tiered royalties ranging from 5%-11% based on annual worldwide net sales. * On October 23, 2014, Medivation and CureTech announced Medivation has licensed exclusive worldwide rights to CureTech's late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody. Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology. The arrangement with CureTech 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 (i.e. a reduction of $2 million in the upfront payment and 1% from each tier of royalties). The shareholder vote on the guaranty and Medivation's exercise of its option to continue to maintain the license are expected to occur in December 2014.
Financial terms: Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5.0 million from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling $85 million. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245 million, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4%-11% based on annual worldwide net sales.
Latest news: * On June 16, 2016, Medivation announced results from a Phase 1/2 study of pidilizumab that demonstrated potential clinical benefit in pediatric patients with diffuse intrinsic pontine glioma (DIPG).
