PharmaMar announces that both Chugai and PharmaMar have entered into a mutual early termination agreement of this license agreement
Chugai Pharmaceutical Co., Ltd. had exercised its right to terminate without cause the License, Development and Commercialization Agreement for Zepsyre® in Japan entered on December 22nd, 2016, with an effective date of termination in April 2019.
PharmaMar announces that both Chugai and PharmaMar have entered into a mutual early termination agreement of this license agreement under which the termination of the license agreement is effective as of today and neither company shall have any further obligation to the other party thereafter.
Consequently, under the terms of this early termination agreement, PharmaMar regains all its rights for Zepsyre® in Japan with immediate effect and will receive a payment of €3,000,000 from Chugai in consideration for the early termination of the license agreement.
PharmaMar continues with the clinical development of Zepsyre® in Japan, while its global registration trial in small-cell lung cancer (ATLANTIS; n=600) is about to finalize recruitment in July 2018.
This pivotal, randomized, Phase III trial assesses the efficacy of Zepsyre® in combination with doxorubicin compared with the standard treatment for this indication.
ATLANTIS trial has successfully passed two safety analyses by the Independent Data Monitoring Committee (IDMC) after the inclusion of 150 and 500 patients. Results for the primary endpoint of overall survival are expected by the second half of 2019.
PharmaMar has begun discussions with new potential licensees for Japan during the recent annual meeting of ASCO (American Society of Clinical Oncology) in June, where the company has presented encouraging clinical data on the use of Zepsyre® in small- cell lung cancer as a single agent, including an overall survival benefit of 11.8 months.