PHARMANOVIA
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
Galderma Opens up New Chapter for Sculptra® with MDR Certification and New Expanded Indication for Body5.12.2025 07:00:00 CET | Press release
Sculptra®, the first proven regenerative biostimulator, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include gluteal area, posterior thighs, décolletage, and upper arms1 Studies investigating the efficacy of Sculptra on areas beyond the face show patients experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour Sculptra’s versatility and new indication allow practitioners to shift patient treatment goals beyond rejuvenation toward enhancement, meeting evolving patient needs The certification validates Sculptra’s safety performance, efficacy, and quality, reinforcing Galderma’s commitment to innovation and meeting evolving patient needs Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its
Northern Escape Heli-Skiing Takes the Title of “World’s Best Heli-Ski-Operator” for the 4th Year Running5.12.2025 02:40:00 CET | Press release
4x World’s Best Heli-Skiing Operation near Terrace, BC Northern Escape Heli-Skiing (NEH) has been named World’s Best Heli-Ski Operator 2025 by the World Ski Awards, marking its fourth straight victory following years 2022, 2023 and 2024. This recognition places NEH amongst an elite group of ski tourism operators consistently voted best in the world by industry leaders and enthusiasts alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204074550/en/ A four-year run built on reliability NEH operates in British Columbia’s Skeena Mountains, where deep northern snow and vast terrain come together with small-group heli-skiing and heli snowboarding. When helicopters can’t safely fly, NEH has cat skiing readily available as a backup — an exceedingly rare offering in this industry. The operation spans over 833,571 wild acres of alpine bowls, glaciers and old-growth tree skiing. The NEH experience Guests choose from three lodge f
IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance5.12.2025 01:00:00 CET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers. IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development. Dr. Yue
Helical Fusion, Developer of Next-Generation Clean Energy Through Nuclear Fusion, Completes USD 5.5M Series A Extension Round5.12.2025 01:00:00 CET | Press release
Stakeholder base expands with participation from an individual-investor-oriented fund, alongside corporate and individual investors, bringing Total Funding to USD 38M Helical Fusion Co., Ltd. (Head Office: Chuo-ku, Tokyo; CEO: Takaya Taguchi; hereafter “Helical Fusion”), which is developing a next-generation energy source using Japan’s original Helical Stellarator technology to realize commercially viable fusion power plant in the 2030s, announced the completion of its Series A Extension round, raising approximately USD 5.5 million (≈ JPY 870 million). The round included investments from “Ecrowd NEXT”, a fund designed for individual investors, as well as multiple corporate investors and individual investors. As a result, Helical Fusion’s total Series A funding, including loans, amounts to approximately USD 21 million (≈ JPY 3.2 billion), bringing the company’s cumulative fundraising—including grants and loans—to approximately USD 38 million (≈ JPY 6.0 billion). With this funding, Helic
Andersen Consulting udvider sin tilstedeværelse gennem samarbejde med Hilal Technology4.12.2025 23:04:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Hilal Technology for at styrke sine kompetencer inden for digital infrastruktur, cybersikkerhed og AI. Med tilstedeværelse i Bahrain, Saudi-Arabien, De Forenede Arabiske Emirater, Oman og Indien leverer Hilal Technology et komplet spektrum af digital infrastruktur og managed services inden for cloudcomputing, cybersikkerhed, enterprise ai og systemintegration. Deres ydelser omfatter cloudtjenester, sikkerheds- og netværksdrift, implementering af ERP og applikationer samt udvikling af generative ai-kapaciteter. Med et team på mere end 250 fagfolk servicerer firmaet en bred vifte af brancher, herunder den finansielle sektor, olie og gas, logistik og den offentlige sektor. "Transformation er mere end systemer; det handler om parathed, tillid og løbende samarbejde," udtaler Roshan George, direktør for Hilal Technology. "Vi er begejstrede for at samarbejde med Andersen Consulting og levere skalerbare løsninger, der matcher tempoet i den dig
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