On August, 29, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported that Novo Nordisk Healthcare AG ("Novo Nordisk"), has exercised its right to terminate the amended development and commercialization license agreement (the "Commerical License") previously entered into between Aeterna’s wholly-owned subsidiary and Novo for Macrilen (macimorelin), the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD) (Press release, AEterna Zentaris, AUG 29, 2022, View Source [SID1234618732]). Following Novo’s 270-day notice period, Aeterna will regain full U.S. and Canadian rights to the product. Under the terms of the Commercial License, Novo Nordisk will return the regulatory approvals, the intellectual property and provide certain other assistance in order to aid in an orderly transition of Macrilen (macimorelin) rights to the Company. Until the end of that 270-day period, Commercial License requires Novo Nordisk to continue selling and promoting Macrilen (macimorelin) in the U.S., and Novo Nordisk’s financial support of the pivotal safety and efficacy DETECT-trial remains unchanged until the end of that notice period.
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"We are delighted to regain full control over macimorelin in the US and Canada. We have always strongly believed in the value of macimorelin and remain fully committed to our plans to continue commercialization in the U.S. and Canada as well as continuing the pediatric development in our ongoing DETECT-trial. As the only U.S. FDA and EU approved diagnostic product for adult growth hormone deficiency, we continue to believe macimorelin remains a compelling opportunity," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "Additionally, we believe that macimorelin’s value has the potential to substantially increase as we plan for success with its potential expanded use in CGHD. As a result, our priority and focus is on identifying a strong partner who shares our vision for the expansion of this important product to maximize the global opportunity for macimorelin in AGHD as well as in CGHD in the near and long term."
Macimorelin has been marketed in the U.S. by Novo Nordisk under the trade name Macrilen. Under the Commercial License, Novo Nordisk was granted an exclusive license for the development, manufacturing, registration and commercialization of Macrilen (macimorelin) in the U.S. and Canada. In light of Novo Nordisk’s decision, Aeterna plans to engage in robust business development efforts to identify and secure a new development and commercialization partner.
"Over the past 18 months, we have made notable progress in building a pre-clinical development pipeline with the goal of diversifying our opportunities. Our growing pipeline, in what we believe are high-value indications with significant unmet medical need, is expected to hold great promise for patients and ultimately our shareholders. Accordingly, we believe regaining the U.S. and Canadian rights to macimorelin provides the Company with additional optionality to drive value creation. Our strong balance sheet as of June 30, 2022, included $58.2 million in cash, allows us to continue the DETECT-trial, invest as we consider prudent in our pipeline, and consider strategic opportunities as we strive to build shareholder value," concluded Dr. Paulini.