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Aeterna Zentaris Inc (3)
Symbol AEZS
Shares Issued 121,397,007
Close 2022-05-25 C$ 0.26
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Aeterna partner Consilient releases Ghryvelin in Europe

2022-05-25 16:41 ET - News Release

Dr. Klaus Paulini reports


Aeterna Zentaris Inc. has noted that Ghryvelin (macimorelin), the first oral test approved for diagnosing growth hormone deficiency in adults (AGHD), is now available to health care professionals across Europe (subject to reimbursement). This availability is possible thanks to Aeterna's licensing partner, Consilient Health, Ltd. ("CH" or "Consilient Health"), a privately owned pharmaceutical company focused on commercializing medicines in Europe and Middle East.

"The development of innovative new medical products is an intensive and rigorous process, so the European launch of Ghryvelin(TM) is a significant milestone for both companies as well as a positive development for patients who require AGHD testing," said Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. "The ability to bring to market an oral, well-tolerated and time-efficient alternative to commonly used labor-intensive tests to diagnose AGHD is a great accomplishment. We are grateful for our partnership with Consilient Health, their demonstrated leadership and expertise, and ability to expand the international reach for macimorelin."

AGHD is most often acquired from a pituitary tumor or trauma to the brain but may also be idiopathic. It is characterized by a number of variable symptoms including reduced energy levels, altered body composition, osteoporosis (reduced bone mineral density), reduced muscle strength, lipid abnormalities such as increased LDL cholesterol, insulin resistance, and impaired cardiac function. Treatment for GHD requires daily injections of recombinant human growth hormone (rHGH).1

Ghryvelin(TM), 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 Ghryvelin(TM) for the assessment of AGHD. Please see Summary of Product Characteristics for full prescribing information.2

European approval of Ghryvelin(TM) was granted in 2019, based on Phase 3 data showing that oral macimorelin provides accuracy comparable to that of standard insulin tolerance testing (ITT), but has a considerably more favorable safety profile compared to ITT. Oral Ghryvelin(TM) also reduces false positive test results, helping to avoid unnecessary treatment of patients.3

Aeterna's licensing partner, Novo Nordisk is currently marketing macimorelin in the United States under the tradename Macrilen(TM).

About Consilient Health

Established in 2005 with headquarters in Ireland, Consilient Health is an independent, dynamic and rapidly growing pharmaceutical company with a rich heritage of commercialising products in complex markets in therapeutic areas such as women's health, urology and endocrinology. The company has a strategy of partnering with innovative companies to bring to medicines to market that serve a clear unmet clinical need. In November 2020 Consilient Health acquired the marketing rights from Aeterna Zentaris to market Ghryvelin(TM) across EU and UK.

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 tradename Macrilen(TM), through a license and assignment agreement with Novo Nordisk and in Europe and the United Kingdom under the tradename Ghryvelin(TM), through a license 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(TM); Ghryvelin(TM)), 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 pre-clinical 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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