Pharmanovia Enters Into an Exclusive Licensing Agreement With Aeterna Zentaris for the First and Only Orally Administered Approved Medicine for the Diagnosis of Growth Hormone Deficiency in Adults

- The Agreement Covers the European Economic Area (EEA) and the UK

- Pharmanovia Will Take Over Rights From Consilient Health and Any Future European Commercial Rights for Paediatric Indications Resulting From the Detect Study

- Deal Complements Existing Endocrinology Portfolio

BASILDON, England--(BUSINESS WIRE)--Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its endocrinology portfolio with a new licensing agreement for GHRYVELIN™ (macimorelin), a novel medicine used for diagnosing Adult Growth Hormone Deficiency (AGHD) from Aeterna Zentaris.

The agreement gives Pharmanovia the exclusive commercial rights in the UK and EEA.

AGHD is a rare and serious condition that affects 2 to 3 people in 10,000 with significant risk of morbidity and reduced quality of life. It is underdiagnosed and often missed in patients.¹

It is characterised by a number of variable and common 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.²

Pharmanovia CEO, Dr James Burt commented; ‘’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-licence novel, complementary products in the therapeutic settings we support.”

“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. Furthermore today’s announcement presents a rare opportunity to license in a medicine that naturally synergises with one of the core growth products in our current portfolio.”

Dr Klaus Paulini, CEO of Aeterna Zentaris, added: “Pharmanovia has expertise marketing diagnostic testing solutions combined with an established footprint in endocrinology across Europe, so this partnership was a natural choice. We’re excited to leverage their knowledge to ensure that more patients benefit from an improved testing experience and reduction in unnecessary treatment for patients.”

About Pharmanovia

Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally.

We do this by enhancing established medicines either by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and through strategic partnerships.

Our diverse and growing team operate in over 160 countries across the globe, delivering high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology.

About Aeterna Zentaris

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercialising 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.

About Macimorelin

Macimorelin is marketed under the brand name GHRYVELIN™ (macimorelin) in the UK and European Economic Area.

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. of GHRYVELIN™ was granted in 2019, based on Phase III data showing that oral macimorelin provides accuracy comparable to that of standard insulin tolerance testing (ITT)⁴, but has a more favourable safety profile compared to ITT. Oral GHRYVELIN™ also reduces false positive test results, helping to avoid unnecessary treatment of patients.³

References

¹ J Endocr Soc. 2022 Jul 1; 6(7): bvac077. Andrew R Hoffman, Tracy Mathison, Deno Andrews, Kristine Murray, Nicky Kelepouris, and Maria Fleseriu - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9165431/ -last accessed 1.3.2023

² Yuen KCJ, Biller BMK, Radovick S, et al -. Endocr Pract. 2019;25(11):1191-1232. https://pubmed.ncbi.nlm.nih.gov/31760824/ - last accessed 1.3.2023

³ Garcia JM et al. Macimorelin as a Diagnostic Test for Adult GH Deficiency. J Clin Endocrinol Metab, 2018, 103(8): 3083-3093 - https://pubmed.ncbi.nlm.nih.gov/29860473/ - last accessed 1.3.2023

⁴ https://www.ema.europa.eu/en/documents/assessment-report/ghryvelin-previously-macimorelin-aeterna-zentaris-epar-public-assessment-report_en.pdf – last accessed 1.3.2023