04:22:37 EDT Sun 24 Sep 2023
Enter Symbol
or Name

Login ID:
Aeterna Zentaris Inc (4)
Symbol AEZS
Shares Issued 4,855,880
Close 2022-08-26 C$ 6.63
Recent Sedar Documents

Aeterna to regain full rights to macimorelin from Novo

2022-08-29 09:31 ET - News Release

Dr. Klaus Paulini reports


Novo Nordisk Healthcare AG has exercised its right to terminate the amended development and commercialization licence agreement previously entered into between Aeterna Zentaris Inc.'s wholly owned subsidiary and Novo for Macrilen (macimorelin), the first and only U.S. Food and Drug Administration- and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). 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 licence, 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, the commercial licence requires Novo Nordisk to continue selling and promoting Macrilen (macimorelin) in the United States, and Novo Nordisk's financial support of the pivotal safety and efficacy Detect trial remains unchanged until the end of that notice period.

"We are delighted to regain full control over macimorelin in the U.S. 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 licence, Novo Nordisk was granted an exclusive licence 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 preclinical 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.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The company's lead product, macimorelin (Macrilen; Ghryvelin), is the first and only U.S. FDA- and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), Parkinson's disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Additionally, the company is in preclinical development of an oral prophylactic bacterial vaccine against SARS-CoV-2 (COVID-19) and chlamydia trachomatis.

We seek Safe Harbor.

© 2023 Canjex Publishing Ltd. All rights reserved.