Aeterna Zentaris’ Licensing Partner, Consilient Health Announces European Launch of Ghryvelin™ (macimorelin) for Diagnosing Adult Growth Hormone Deficiency

Rhea-AI Summary

Aeterna Zentaris (NASDAQ: AEZS) announces the European launch of Ghyrvelin™ (macimorelin), the first oral test for diagnosing Adult Growth Hormone Deficiency (AGHD). The product is available through their licensing partner, Consilient Health, marking a significant milestone for the company. Ghryvelin™ offers a well-tolerated, efficient alternative to traditional testing methods. The European approval came in 2019 based on Phase 3 data showing comparable accuracy to insulin tolerance testing, with a superior safety profile.

Positive

• Launch of Ghryvelin™ in Europe enhances Aeterna's market presence.
• Ghyrvelin™ provides a safer, more patient-friendly alternative to traditional AGHD tests.
• Partnership with Consilient Health expands the commercial reach of macimorelin.

Negative

• None.

TORONTO, ONTARIO, May 25, 2022 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, today announced that Ghryvelin^™ (macimorelin), the first oral test approved for diagnosing Growth Hormone Deficiency in adults (AGHD), is now available to healthcare 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^™ 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^™, 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^™ for the assessment of AGHD. Please see Summary of Product Characteristics for full prescribing information.²

European approval of Ghryvelin^™ 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^™ 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^™.

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^™ 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^™, through a license and assignment agreement with Novo Nordisk and in Europe and the United Kingdom under the tradename Ghryvelin^™, 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^™; 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, 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.

For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations and such statements are made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "potential," "possible," and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking statements in this press release include, but are not limited to, those relating to: expectations regarding the commercialization of Ghryvelin^™ and any future plans with respect to the development of macimorelin for CGHD.

Forward-looking statements involve known and unknown risks and uncertainties, and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others, results from ongoing or planned pre-clinical studies of our products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our now heavy dependence on the success of macimorelin (sold under the trade names Macrilen^® in the United States and Ghryvelin^™ in the EU) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the license agreement and the amended license agreement (collectively the Novo Amended License Agreement) and our license agreement with Consilient Health; the global instability due to the global pandemic of COVID-19 and the war in Ukraine and the resulting geopolitical instability, and its unknown potential effect on our planned operations; our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; and our ability to continue to list our common shares on the NASDAQ. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties, including those risks discussed in our Annual Report on Form 20-F, under the caption "Risk Factors". Given the uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

No securities regulatory authority has either approved or disapproved of the contents of this news release. The Toronto Stock Exchange accepts no responsibility for the adequacy or accuracy of this release..

Investor Contact:

Jenene Thomas
JTC Team
T (US): +1 (833) 475-8247
E: aezs@jtcir.com

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¹ Pituitary Foundation. Growth Hormone Factsheet. Available online at: https://www.pituitary.org.uk/media/624527/GHfact-sheet-2018_EMAIL.pdf (last accessed May 2022)
² Ghryvelin^™ Summary of Product Characteristics. Available online at: https://www.ema.europa.eu/en/medicines/human/EPAR/ghryvelin-previously-macimorelin-aeterna-zentaris (last accessed May 2022)
³ Garcia JM et al. Macimorelin as a Diagnostic Test for Adult GH Deficiency. J Clin Endocrinol Metab, 2018, 103(8): 3083-3093

FAQ

What is Ghryvelin™ and when was it launched in Europe?

Ghyrvelin™ (macimorelin) is the first oral test approved for diagnosing Adult Growth Hormone Deficiency (AGHD) and was launched in Europe on May 25, 2022.

Who is Aeterna Zentaris's licensing partner for Ghryvelin™?

Aeterna Zentaris's licensing partner for Ghryvelin™ is Consilient Health, which is responsible for its commercialization across Europe.

What are the benefits of using Ghryvelin™ for AGHD testing?

Ghyrvelin™ is a well-tolerated oral medication that offers a less labor-intensive, safer alternative to traditional insulin tolerance tests for AGHD.

What is the significance of the European approval for Ghryvelin™?

The European approval, granted in 2019, is significant as it validates the product's effectiveness and safety compared to traditional testing methods, enhancing its market potential.

What clinical data supported Ghryvelin™'s approval?

Ghyrvelin™'s approval was based on Phase 3 data showing its accuracy in diagnosing AGHD comparable to insulin tolerance testing, with a favorable safety profile.