Zoptrex, a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE), is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer.
The Company expects to complete the Phase 3 clinical trial in the third quarter of 2016 and, if the results of the trial warrant doing so, to file a new drug application for Zoptrex in the first half of 2017.
Under the terms of the License Agreement, Aeterna Zentaris will be entitled to receive a non-refundable upfront payment in consideration for the license to Cyntec of the Company’s intellectual property related to Zoptrex and the grant to Cyntec of the right to commercialize Zoptrex in the Territory.
Cyntec has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones.
Furthermore, the Company will receive royalties on future net sales of Zoptrex in the Territory. Cyntec will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory.
David Dodd, President and CEO of the Company, stated, "We are very excited about this arrangement with OEP. It is an important step in our strategy of leveraging our pipeline to secure future revenues with strategic development and commercial licensees for specific regions of the world. We are very pleased that OEP’s affiliates will commercialize Zoptrex in the Territory, providing women with advanced endometrial cancer a significant treatment option.
"Their experience and commitment to ensuring the success of Zoptrex in their Territory is most assuring. We look forward to similar, additional agreements as we progress towards the completion of the pivotal Phase 3 trial and the subsequent reporting of top-line results later this year."
Commenting on the signing of the agreement, Peter Tsai, Chairman and CEO of OEP stated, "With our advantage of the comprehensive sales network and operation over Southeast Asia market which we have cultivated for years, we successfully signed the partnership with Aeterna Zentaris and the outstanding endometrial cancer treatment. The exclusive license agreement gives us more confidence in exploring the Asian market with a stronger product portfolio."
About Zoptrex
Zoptrex is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is [D-Lys6]-LHRH, a modified natural hormone believed to have a strong affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors.
Potential benefits of this targeted approach include enhanced efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin.