Dr. Klaus Paulini reports

AETERNA ZENTARIS SECURES NEW EUROPEAN PATENT RELATED TO USE OF MACIMORELIN FOR THE DIAGNOSIS OF GROWTH HORMONE DEFICIENCY IN ADULTS

The European Patent Office (EPO) has issued Aeterna Zentaris Inc. a patent providing intellectual property protection of macimorelin in 27 countries within the European Union as well as additional European non-EU countries, such as the United Kingdom and Turkey, for macimorelin (Ghryvelin, Macrilen) for use to diagnose growth hormone deficiency (GHD) in adults.

Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone (GH) from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD. Macimorelin is the only U.S. Food and Drug Administration- and European Commission-approved oral diagnostic for adult growth hormone deficiency.

Dr. Klaus Paulini, chief executive officer of Aeterna, commented: "Patents are an important tool to protect our intellectual property and a critical step in bringing any new drug to market. So we are pleased to have such stronger protection around our innovative product Ghryvelin/ Macrilen in the EU, and several non-EU countries. There is also an opportunity to build greater protection by entering the patent in the national phase in 41 European countries, and we will move ahead with a plan to take advantage of this. This patent also provides protection for our licensing partner in Europe and the United Kingdom, Consilient Health, for the commercialization of macimorelin."

Patent details

The patent was issued pursuant to Article 97 (1) of the EPC (European Patent Convention), with the No. EP3729100. The new European patent covers the use of macimorelin to detect GHD in adults, with a base patent term extending until 2038. The EP3729100 patent claims exactly the label of the product approved by the European Commission (EC) in January, 2019. The patent provides intellectual property protection of macimorelin in 27 countries within the European Union as well as additional European non-EU countries, such as the U.K. and Turkey.

About macimorelin

Macimorelin is the 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 and assignment agreement with Novo Nordisk, and in Europe and the United Kingdom under the trade name Ghryvelin, through a licence agreement with Consilient Health Ltd.

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), 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, in collaboration with Novo Nordisk.

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 developing an oral prophylactic bacterial vaccine against SARS-CoV-2 (COVID-19) and chlamydia trachomatis.

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