On April 27th, 2018 PharmaMar reported to National Securities Market Commission that Chugai Pharmaceutical 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.
"We thank Chugai for the great relationship in the past. The mutual termination now offers PharmaMar the opportunity to engage in a new partnership for Japan, while Chugai can focus on its own pipeline," Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, said.
Zepsyre (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.