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
Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press release
ARK Invest, backer of OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund and Schooner Capital back new round bringing total funding to $110M Plans to scale to 40 bases in the United States, supported by seven years of operational orchestration experience, and recently expanded its global partnerships with Uber, joining Deliveroo, Just Eat and DoorDash in delivering everyday items by air. Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include
Bureau Veritas Launches an Independent AI Assessment Offering for European Enterprises, Developed in Partnership with Amazon Web Services (AWS)1.4.2026 17:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the launch of an AI systems audit to help European enterprises assess and demonstrate their compliance with the European Union's "AI Act" regulatory requirements. This offering combines on-site audits, document analysis, and direct testing to deliver an independent maturity report. Since the EU's AI regulation came into force in 2024, companies have faced major implementation challenges. According to a recent report*, 68% of them struggle to interpret the provisions of the text, while 60% have yet to put in place the governance needed to comply. Non-compliance can cost them up to 7% of annual revenue. Bureau Veritas has developed this new audit offering to help companies identify their compliance gaps and remedy them. Bureau Veritas's new audit offering comprises a pre-audit, document review, on-site audit, and direct testing, resulting in an independent report on the client's AI maturit
Greenland Resources Signs Eight Year Off-take Agreement With SSAB to Supply High Quality Molybdenum1.4.2026 16:29:00 CEST | Press release
Greenland Resources Inc. (TSX:MOLY, FSE:M0LY) (“Greenland Resources” or the “Company”) is pleased to announce the Company has signed a binding off-take agreement with SSAB, a Nordic and US-based steel producer headquartered in Sweden. The company is a leading producer on the global market for advanced high-strength steels providing solutions to the defence, automotive, infrastructure and energy industries. A stock exchange press release from SSAB can be found on their website at www.ssab.com This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401270749/en/ The off-take agreement provides an established price floor and price ceiling and will allow SSAB to secure high quality low carbon emission ferromolybdenum extracted in Greenland and refined in Belgium. SSAB will be able to ensure a stable and responsibly sourced long term secured primary molybdenum supply with high sustainability standards and low scope 1&2 emissions from a
VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System1.4.2026 15:30:00 CEST | Press release
VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system. The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDYNE system in patients with severe tricuspid regurgitation (TR). “This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.” Significant unmet clinical needs exist in the
NetJets Introduces State-of-the-Art, Exclusive-Use Terminal in Augusta, Georgia1.4.2026 15:05:00 CEST | Press release
New facility set to elevate the experience for customers during golf’s most celebrated event—and beyond NetJets, the global leader in private aviation, is well underway on its development of a new exclusive-use terminal at Augusta Regional Airport (AGS). This state-of-the-art facility represents a significant investment in the region and reinforces NetJets’ commitment to delivering unparalleled experiences for its customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330125414/en/ NetJets to open a new, exclusive-use terminal at Augusta Regional Airport (AGS). Guests arriving this April for golf’s most iconic championship will witness the construction in progress, including the finished ramp and foundational walls of what will soon become a full-service terminal. The private ramp, offering 432,000 square feet of space for aircraft parking, will be completed in time for the 2026 golf tournament. “Augusta is a key desti
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