PHARMANOVIA
16.3.2023 13:51:39 CET | Business Wire | Press release
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005846/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release
If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids
Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release
Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use
DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release
-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating
HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 11:18:00 CEST | Press release
HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi
Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 10:28:00 CEST | Press release
Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom