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Aeterna signs macimorelin licensing deal

2020-12-07 09:48 ET - News Release

Mr. Ahmed Al-Derzi reports

AETERNA ZENTARIS ANNOUNCES EUROPEAN LICENSING AGREEMENT WITH CONSILIENT HEALTH LTD. FOR COMMERCIALIZATION OF MACIMORELIN

Aeterna Zentaris Inc. has entered into an exclusive licensing agreement with Consilient Health Ltd. (CH), a privately owned pharmaceutical company focused on commercializing medicines in Europe and Middle East, for the commercialization in Europe and the United Kingdom of macimorelin, Aeterna's orally available ghrelin agonist, in any diagnostic application, including the diagnosis of patients with adult growth hormone deficiency (AGHD) and, subject to receipt of regulatory approval, childhood-onset growth hormone deficiency (CGHD).

Under the terms of the agreement, CH will be responsible for obtaining pricing and reimbursement approval in the European economic area and the United Kingdom, as well as bearing the regulatory cost for the label extension for pediatric use pending successful outcome of the upcoming safety and efficacy study, AEZS-130-P02 (study P02), evaluating macimorelin for the diagnosis of CGHD. This pivotal phase 3 study P02 is expected to be initiated in Q1 of 2021. Aeterna and Consilient Health have also entered into a separate commercial supply agreement under which Consilient Health will purchase macimorelin from Aeterna and Aeterna will be responsible for supply and product quality. Aeterna will continue to maintain control of its patents covering macimorelin in Europe and the United Kingdom.

As agreed, Consilient Health will make an upfront payment to Aeterna of one million euros and will pay to Aeterna royalties on net sales of macimorelin ranging from 10 per cent to 20 per cent depending on the level of net sales achieved by Consilient Health in the particular year. Aeterna will also be eligible to receive milestone payments associated with the achievement of pricing and reimbursement approvals in certain countries in Europe and in the United Kingdom, upon approval of macimorelin in CGHD, and on the attainment by Consilient Health of other sales-based events.

"This licence agreement represents another significant milestone for the company as we continue to secure and bolster our portfolio of marketing partners for macimorelin in key markets. As a synergistic partner of choice with insight and commercialization capabilities, we believe that Consilient Health brings noteworthy expertise that is the right fit for Aeterna. We are grateful for their partnership and look forward to leveraging their experience in driving innovative marketing to our international distribution network for macimorelin," commented Dr. Klaus Paulini, chief executive officer of Aeterna Zentaris.

Commenting on the agreement, Ahmed Al-Derzi, Consilient Health's chief executive officer, stated: "We are delighted to build this partnership with Aeterna Zentaris for macimorelin. Not only does the brand further strengthen our growing offering to endocrinology specialists and their patients but it also strengthens CH's position across Europe. Macimorelin is an exciting innovation in the field of growth hormone deficiency."

In addition to advancing its pediatric program, Aeterna is actively pursuing its business development activities with the goal of securing marketing partners for macimorelin for the diagnosis of growth hormone deficiency in additional markets where the company does not already have partnership agreements.

About macimorelin

Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD.

In December, 2017, the United States Food and Drug Administration (FDA) granted Aeterna Zentaris marketing approval for macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency. Macrilen has been granted orphan drug designation by the FDA for diagnosis of AGHD. In January, 2019, the European Commission granted marketing authorization for macimorelin to Aeterna Zentaris for diagnosis of growth hormone deficiency in adults. In March, 2017, the pediatric committee of the EMA agreed to the company's PIP for macimorelin, a prerequisite for filing a marketing authorization application for any new medicinal product in Europe.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The company's lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the trade name Macrilen through a licence agreement with Novo Nordisk where Aeterna Zentaris receives royalties on sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established licence agreement with Consilient Health Ltd. and Aeterna Zentaris will receive royalties on sales and other potential payments.

Aeterna Zentaris is also 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.

The company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value.

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