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Aeterna Zentaris Inc (4)
Symbol AEZS
Shares Issued 4,855,880
Close 2023-03-15 C$ 3.65
Market Cap C$ 17,723,962
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Aeterna partner licenses Ghryvelin to Pharmanovia

2023-03-16 11:26 ET - News Release

Dr. Klaus Paulini reports


Pharmanovia, a global life cycle management health care company, has acquired from Aeterna Zentaris Inc.'s existing EEA (European economic area) and United Kingdom partner, Consilient Health, the exclusive rights and licence to commercialize Ghryvelin (macimorelin) in the territory, for the diagnosis of adult growth hormone deficiency (AGHD) and, if approved, for childhood-onset growth hormone deficiency (CGHD).

Dr. Klaus Paulini, chief executive officer of Aeterna, commented: "Pharmanovia has established global expertise in marketing diagnostic testing solutions in addition to an established footprint in endocrinology across Europe. They are positioned as the natural choice as our commercialization partner moving forward. We believe that the decision by Pharmanovia to invest in Ghryvelin demonstrates the future potential of Ghryvelin, and is an endorsement of the efforts made to date by both Aeterna Zentaris and our former licensee, Consilient Health's, to obtain approval for and launch Ghryvelin in Europe. We are excited to now have Pharmanovia as a partner as we continue our efforts to benefit patients."

"Endocrinology is the largest of our four core therapy areas and the in-licensing of this important novel medicine, the second in-licensing deal of a novel medicine in almost as many weeks, speaks to our ability to in-license novel, complementary products in the therapeutic settings we support," commented Pharmanovia CEO, Dr. James Burt. "We are well placed to use the knowledge and the platform we've built through our current endocrinology work, to ensure that more patients get the diagnosis they need for this rare and serious condition."

In 2022, Aeterna Zentaris announced that it will regain full rights to Macrilen for the United States and Canada from Novo Nordisk in May, 2023, and the company is actively seeking an alternate development and commercialization partner for Macrilen in the U.S., Canada and for other territories currently not partnered.

About macimorelin (Macrilen, G Hryvelin)

Macimorelin is marketed under the brand name Ghryvelin (macimorelin) in the U.K. and European economic area, and Macrilen in the United States for the diagnosis of adult growth hormone deficiency (AGHD). In addition, Aeterna Zentaris is currently conducting a pivotal phase 3 safety and efficacy study, AEZS-130-P02 (also referred to as the Detect study), evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD).

Macimorelin (Macrilen, Ghryvelin), 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 AGHD. Approval of macimorelin was granted by the FDA (Food and Drug Administration) in 2017 and by the EMEA in 2019, based on phase 3 data showing that oral macimorelin provides accuracy comparable with that of standard insulin tolerance testing (ITT), but has a more favourable safety profile compared to ITT. Oral macimorelin also reduces false positive test results, helping to avoid unnecessary treatment of patients.

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).

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