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
Crown Bioscience and Turbine Partner to Connect AI-Driven Prediction with Organoid Validation in Translational Oncology21.4.2026 14:30:00 CEST | Press release
Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, today announced a strategic partnership with Turbine, a leading virtual biology company, to advance translational oncology research by integrating Turbine’s in silico Virtual Assays with its Tumor Organoid Assays based on HUB Organoid Technology. This collaboration establishes a connected workflow that enables researchers to move more efficiently from hypothesis to validation. Turbine’s Virtual Assays simulate biological response across thousands of biological samples and hundreds of drugs, generating predictive insights to identify and prioritize targets, therapies, and combinations. The predictions will be enhanced through the incorporation of multimodal and drug response data from hundreds of tumor organoid models at Crown Bioscience. Together, the companies create a closed-loop approach linking prediction with validation, improving predictive accuracy, reducing experimental burden, whil
Responding to Customer Demand, Starlink High-Speed Connectivity Now Available as an Aftermarket Option on the Cessna Citation Ascend; 560XL Series Achieves EASA Certification21.4.2026 14:00:00 CEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced at AERO Friedrichshafen the availability of Starlink highspeed connectivity as an aftermarket upgrade for the Cessna Citation Ascend, the newest aircraft in the bestselling Cessna Citation 560XL series, following the Federal Aviation Administration’s issuance of AeroMech’s Supplemental Type Certificate (STC). In addition, the Cessna Citation 560 XL fleet — including the XLS Gen 2, XLS+, XLS and Excel — has received European Union Aviation Safety Agency (EASA) certification for Starlink installation at Textron Aviation’s European service centers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260420017406/en/ Responding to customer demand, Starlink high-speed connectivity now available as an Aftermarket option on the Cessna Citation Ascend; 560XL series achieves EASA certification AeroMech’s STC utilizes Starlink’s high-speed internet technology connec
Moody’s Advances Decision-Grade Credit Intelligence Across Enterprise AI Workflows, Powered by Microsoft 365 Copilot21.4.2026 14:00:00 CEST | Press release
Moody’s decision-grade intelligence now available directly in the AI-powered tools where market participants work Moody’s Corporation (NYSE: MCO) today announced the next phase of its strategic partnership with Microsoft, integrating Moody’s decision-grade intelligence directly into Microsoft AI solutions. The milestone expands the collaboration from co-innovation to scaled, workflow-embedded distribution of Moody’s decision-grade intelligence across the enterprise environments where its customers work every day. “For over 115 years, Moody’s has served as the intelligence layer that financial professionals turn to when making consequential decisions,” said Rob Fauber, President and Chief Executive Officer of Moody’s. “By embedding that intelligence directly into Microsoft’s AI solutions at enterprise scale, we’re making decision-grade analysis available not just to specialists, but to every person across an organization who needs it.” The integrations operate across two channels. Using
Redslim expands its global footprint into Latin America21.4.2026 14:00:00 CEST | Press release
Redslim, a specialist in end-to-end data management solutions and an Astorg portfolio company, today announced its expansion into the Latin America (LATAM) region, marking the next step in its growth strategy to support multinational brands and retailers across every major market. Following its recent expansion into APAC, this move reinforces Redslim’s momentum in building a truly global presence, reflecting growing demands from international clients for a trusted partner delivering reliable and AI-ready data and insights at scale. The expansion includes the appointment of Alejandro Merlo as Regional Director and Javier Gonzalez as Regional Manager for the region. Latin America represents a strong growth opportunity for global consumer brands, but also one of the most complex data environments. Rapid digital adoption and shifting consumer behaviours are driving demand for reliable market intelligence, while fragmented retailer structures and country-specific data landscapes make consis
Adtran’s SDG router portfolio receives FCC conditional approval, supporting ongoing broadband expansion21.4.2026 14:00:00 CEST | Press release
News summary: FCC approval exempts Adtran’s SDG router portfolio from Covered List restrictions through October 1, 2027 Decision enables uninterrupted shipments, authorizations and deployments across current and next-generation SDG platforms Regulatory clarity supports long-term SDG investment and rollout planning Adtran today announced that its service delivery gateway (SDG) carrier-grade router portfolio has received conditional approval from the FCC’s Public Safety and Homeland Security Bureau, formally exempting the platforms from FCC Covered List restrictions through October 1, 2027. The decision places Adtran among the first router manufacturers to achieve this designation under the FCC’s national security review process. By ensuring continued access to Adtran’s SDG technology, the approval enables service providers to maintain deployment momentum, reduce operational risk and invest confidently in the long-term expansion of broadband networks while navigating evolving regulatory
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