Aeterna Zentaris (AEZS), Specialised Therapeutics Enter Zoptrex Licensing Agreement in Australia, New Zealand

October 12, 2016 8:01 AM EDT

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Aeterna Zentaris Inc. (Nasdaq: AEZS) and Specialised Therapeutics Asia announced the signing of an exclusive license agreement for the Company’s lead investigational anti-cancer compound, Zoptrex™ (zoptarelin doxorubicin), for the territories of Australia and New Zealand (the “Territory”). Zoptrex™, a novel synthetic peptide carrier linked to doxorubicin, is currently undergoing a fully-enrolled Phase 3 clinical trial to evaluate the compound in endometrial cancer. The Company expects to complete the Phase 3 clinical trial in 2016 and, if the results of the trial warrant doing so, to submit a new drug application for Zoptrex™ to the United States Food and Drug Administration (FDA) in the first half of 2017. Zoptrex™ is the Company’s proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the FDA.

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 STA of the Company’s intellectual property related to Zoptrex™ and the grant to STA of the right to commercialize Zoptrex™ in the Territory. STA has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones, as well as double-digit royalties on future net sales of Zoptrex™ in the Territory. STA will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory. The Company and STA have also entered into a supply agreement, pursuant to which the Company will supply Zoptrex™ to STA for the duration of the license agreement.

David Dodd, President and CEO of the Company, stated, “I am very pleased that we have now concluded four agreements for the commercial rights to Zoptrex™, if approved, outside the United States. We believe that the interest in Zoptrex expressed by our licensees supports our view that Zoptrex™, if it is approved by the FDA for its initial indication, could be an important treatment option for women with the most severe form of endometrial cancer. We are particularly pleased to have a company of the caliber of STA as a licensee. STA enjoys the highest reputation in its markets and, with its existing portfolio of oncology products, it has the capability to position Zoptrex™ very well in the market.”

STA Chief Executive Officer Mr. Carlo Montagner said Zoptrex™ had demonstrated great potential and was poised to add further value to the company’s expanding oncology portfolio. “All results to date suggest Zoptrex™ is a potent new compound and we look forward to collaborating closely with Aeterna Zentaris to maximise its full potential in our key markets,” he said.

About Zoptrex™

Zoptrex™ (zoptarelin doxorubicin) 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.

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