Aeterna Zentaris & Orient Europharma Sign License Agreement

Aeterna Zentaris Inc. and Orient EuroPharma Co., Ltd. recently announced the signing of an exclusive license agreement between the company and Cyntec Co., Ltd., an affiliate of OEP (Cyntec), for the company’s lead anti-cancer compound, Zoptrex (zoptarelin doxorubicin), for the initial indication of endometrial cancer, for Taiwan and nine countries in Southeast Asia (the Territory). Zoptrex, a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE), is currently in a fully enrolled Phase III clinical trial in endometrial cancer. The company expects to complete the Phase III 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.

“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 toward the completion of the pivotal Phase III trial and the subsequent reporting of top-line results later this year,” said David Dodd, President and CEO of the company.

“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,” added Peter Tsai, Chairman and CEO of OEP.

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.

Founded in 1982, Orient EuroPharma Co., Ltd (OEP) was officially listed in the Gre-Tai Securities market in 2003, and consolidated net sales exceeded $5 billion in the 2014 financial year. Currently, OEP has more than 800 staff worldwide, in which over 40% are overseas employees. OEP’s products include pharmaceuticals, cancer drugs, cosmeceutical, infant and adult nutrition and healthcare products. OEP also established a subsidiary company focused on developing and manufacturing new drugs. OEP is one of multinational pharmaceutical companies able to integrate pharmaceutical research and development, clinical trial, manufacture and marketing in Taiwan.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology, and women’s health. It is engaged in drug development activities and in the promotion of products for others. The company is now conducting Phase III studies of two internally developed compounds. The focus of its business development efforts is the acquisition or license of products that are relevant to its therapeutic areas of focus. The company also intends to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable it to ensure development, registration, and launch of product candidates.