Italfarmaco and Medis Announce Exclusive Distribution Agreement for Givinostat in 17 Central and Eastern European Countries including the Baltic States

• Medis will have exclusive distribution rights in 17 EU and non-EU countries for givinostat once approved

• Regulatory approvals for givinostat as a treatment of Duchenne muscular dystrophy obtained in the US and UK; EMA evaluation ongoing

/EIN News/ -- MILAN and LJUBLJANA, Slovenia, March 18, 2025 (GLOBE NEWSWIRE) -- Italfarmaco S.p.A. and Medis, a leading pharmaceutical commercialisation company in Central and Eastern Europe, today announced an exclusive distribution agreement for givinostat, Italfarmaco’s drug for the treatment of Duchenne muscular dystrophy (DMD). Once approved by the EMA and relevant regulatory bodies, this partnership will facilitate patient access to givinostat across 17 EU and non-EU countries covered by the agreement. No financial terms were disclosed.

Givinostat has already received regulatory approval in the US and UK, with an evaluation ongoing by the European Medicines Agency (EMA).

Under the terms of the agreement, Italfarmaco grants Medis exclusive distribution rights for givinostat in Poland, Romania, Czech Republic, Hungary, Bulgaria, Slovakia, Croatia, Slovenia, Lithuania, Latvia, and Estonia. The non-EU countries within the agreement include Serbia, Albania, Kosovo, Bosnia and Herzegovina, North Macedonia, and Montenegro. Medis will be responsible for the full commercialisation of givinostat, including market access, medical, sales and marketing activities, and supply.

Antonio Nardi, Vice President and Head of Business & Portfolio Development of Italfarmaco, said, “We understand the challenges that families affected by DMD face every day. Ensuring that patients in Central and Eastern Europe have access to givinostat is not just important - it’s essential. By partnering with Medis, which has deep expertise and a strong infrastructure in rare diseases, we can help bring this much-needed treatment to patients who need it most.”

Martina Perharič, Chief Business Officer at Medis, added, “Living with DMD is incredibly challenging for patients and their families, and access to effective treatment can make a real difference in their lives. With our deep regional knowledge and strong local presence, Medis will ensure a seamless and timely introduction of givinostat across Central and Eastern Europe as soon as approvals are in place. We are dedicated to supporting patients every step of the way.”

About Duchenne Muscular Dystrophy

DMD is a progressive neuromuscular disorder caused by a mutation in the DMD gene which affects the production of a protein called dystrophin.¹ Dystrophin is a critical component of the dystrophin-associated protein complex (DAPC) which supports the strength, stability, function and repair of muscle cells. In DMD, muscle fibers are highly susceptible to injury and this continuous muscle injury leads to chronic inflammation, impairment of muscle regeneration and muscle replacement by fibrotic and fat tissue.^{2, 3-5} The disease primarily affects boys, with symptoms usually first seen between two and five years of age. Symptoms worsen over time affecting the ability to walk. Eventually, heart and respiratory muscles are affected, which are the two main causes of premature death.⁶ DMD is one of the most severe and common forms of childhood muscular dystrophy, with a worldwide birth incidence of around 1 in 5,050 boys.⁷

About Givinostat

Givinostat was discovered through Italfarmaco’s research and development efforts in collaboration with Telethon and Duchenne Parent Project (Italy). Givinostat is an orally administered histone deacetylases (HDAC) inhibitor. HDAC is activity upregulated in DMD muscle and has the potential to modify the expression of certain genes and biological processes involved in muscle repair and inflammation.^{8, 9}

About ITALFARMACO

Founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company that has led the successful development and approval of many pharmaceutical products around the world. The Italfarmaco group has operations in more than 60 countries through directly controlled or affiliated companies. The company is a leader in pharmaceutical research, product development, production and commercialisation with proven success in many therapeutic areas including immuno-oncology, gynaecology, neurology, cardiovascular disease and rare diseases. Italfarmaco's rare disease unit includes programmes in Duchenne muscular dystrophy, Becker muscular dystrophy, amyotrophic lateral sclerosis and polycythaemia vera.

About Medis

Medis is the commercialization partner of choice for the world’s leading innovative pharmaceutical and biotech companies, serving as their exclusive partner in Central and Eastern Europe & Greece. Headquartered in Ljubljana, Slovenia, Medis specializes in the comprehensive commercialization of life-changing and innovative therapies, ensuring better access to modern, effective, and safe treatments for patients across 19 countries in the region. With a strong local presence in every country and deep knowledge of the region’s complex healthcare systems, Medis helps its partners overcome market access and other barriers with speed and precision. Medis is also a proud member of the World Orphan Drug Alliance (WODA), a global network of full-service commercial distributors for rare and specialty medicines, covering 158 markets worldwide.

Contacts
For Italfarmaco
Media enquiries:
Anja Heuer / Jacob Verghese |+49 (0) 151 106 199 05 | italfarmaco@trophic.eu

Other enquiries:
Patient Advocacy and Communications Lead| s.parker@italfarmacogroup.com

For Medis

Tina Vojnovic|+386 (0)31 744 735| pr@medis.com

References:

1. Ryder S, Leadley RM, Armstrong N, et al. The burden, epidemiology, costs and treatment for Duchenne muscular dystrophy: an evidence review. Orphanet J Rare Dis. 2017;12(1):79. doi:10.1186/s13023-017-0631-3.
2. Sandonà M, Cavioli G, Renzini A, et al. Histone Deacetylases: Molecular Mechanisms and Therapeutic Implications for Muscular Dystrophies. Int J Mol Sci. 2023;24(5):4306. https://doi.org/10.3390/ijms24054306.
3. Consalvi S, Saccone V, Giordani L, Minetti G, Mozzetta C, Puri PL. Histone Deacetylase Inhibitors in the Treatment of Muscular Dystrophies: Epigenetic Drugs for Genetic Diseases. Mol Med. 2011;17(5):457–465. https://doi.org/10.2119/molmed.2011.00049.
4. Bez Batti Angulski A, Hosny N, Cohen H, et al. Duchenne muscular dystrophy: disease mechanism and therapeutic strategies. Front Physiol. 2023;14:1183101. https://doi.org/10.3389/fphys.2023.1183101.
5. Giuliani G, Rosina M, Reggio A. Signaling pathways regulating the fate of fibro/adipogenic progenitors (FAPs) in skeletal muscle regeneration and disease. FEBS J. 2022;289(21):6484–6517. https://doi.org/10.1111/febs.16080.
6. Walter MC, Reilich P. Recent developments in Duchenne muscular dystrophy: facts and numbers. J Cachexia Sarcopenia Muscle. 2017;8(5):681–685. https://doi.org/10.1002/jcsm.12245.
7. Crisafulli S, Sultana J, Fontana A, Salvo F, Messina S, Trifirò G. Global epidemiology of Duchenne muscular dystrophy: an updated systematic review and meta-analysis. Orphanet J Rare Dis. 2020;15(1):141. https://doi.org/10.1186/s13023-020-01430-8.
8. Comi G, Bertini E, Vita G, et al. S22.008: Development of the histone deacetylases inhibitor Givinostat in Duchenne Muscular Dystrophy. Poster. Neurology. 2018;90(15 (Supplement)).
9. Licandro SA, Crippa L, Pomarico R, et al. The pan HDAC inhibitor Givinostat improves muscle function and histological parameters in two Duchenne muscular dystrophy murine models expressing different haplotypes of the LTBP4 gene. Skelet Muscle. 2021;11(1):19. https://doi.org/10.1186/s13395-021-00273-6.