Santhera signs agreement with GEN for the distribution of AGAMREE® (vamorolone) in Turkey
Wednesday, August 13, 2025
Santhera Pharmaceuticals announces the signing of an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN) for the distribution and commercialization of AGAMREE® (vamorolone) in Turkey for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
Supply and sales by GEN are expected to begin in the first half of 2026, initially on a named-patient basis, followed by commercial distribution. Santhera has received a small upfront payment and will receive an ongoing percentage of net sales, in accordance with existing agreements.
Dario Eklund, Chief Executive Officer of Santhera, said: "As a leader in the Turkish specialty pharmaceutical market, GEN was a natural choice for Santhera when we were looking for a high-quality distribution partner. We look forward to working closely together toward market launch in 2026 to provide access to this medicine for the many DMD patients who lack suitable treatment options."
Abidin Gülmüş, Chairman/CEO of GEN, added: "The potential of AGAMREE is evident, and we are committed to ensuring that this DMD therapy reaches patients in Turkey without delay. We know the rare disease market very well, leverage our long-standing experience in neuromuscular diseases, and look forward to working with Santhera in the coming months and years."
About AGAMREE® (vamorolone)
AGAMREE is a novel drug with a mechanism of action based on binding to the same receptor as glucocorticoids, but modifying their downstream activity. Furthermore, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzyme, which is thought to be responsible for locally elevated drug levels and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has the potential to decouple efficacy from the safety concerns associated with steroids, thus positioning AGAMREE as a dissociative anti-inflammatory and alternative to existing corticosteroids, the current standard of care for children and adolescents with DMD [1-4].
In the pivotal VISION-DMD study, AGAMREE met the primary endpoint of standing-to-stand speed (TTSTAND) compared to placebo (p=0.002) after 24 weeks of treatment and demonstrated a favorable safety and tolerability profile [1, 4]. The most frequently reported adverse events were Cushingoid appearance, vomiting, weight gain, and irritability. In general, adverse events were mild to moderate in severity.
Currently available data show that, unlike corticosteroids, AGAMREE does not restrict growth [5] and has no adverse effects on bone metabolism, as demonstrated by normal serum markers of bone formation and resorption [6].
This medicine is subject to additional monitoring. This allows new safety information to be identified quickly. Healthcare professionals are asked to report any suspected side effects.
Referenzen:
- Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.
- Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.
- Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293
- Heier CR et al (2019). Life Science Alliance DOI: 10.26508
- Ward et al., WMS 2022, FP.27 - Poster 71. Link.
- Hasham et al., MDA 2022 Poster presentation. Link.
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare neuromuscular diseases with high unmet medical need. The company has an exclusive license from ReveraGen for all indications worldwide for AGAMREE® (vamorolone), a dissociative steroid with a novel mechanism of action, which has been investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), in the U.K. by the Medicines and Healthcare Products Regulatory Agency (MHRA), in China by the National Medical Products Administration (NMPA), and in Hong Kong by the Department of Health (DoH). Santhera has licensed the rights to AGAMREE to Catalyst Pharmaceuticals for North America and to Sperogenix Therapeutics for China and certain countries in Southeast Asia. Further information can be found at www.santhera.com .
AGAMREE® is a registered trademark of Santhera Pharmaceuticals.
About GEN
Gen İlaç ve Sağlık Ürünleri San. Ve Tic. A.Ş. (BIST: GENIL.IS) is Turkey's leading specialty pharmaceutical company, focusing on developing innovative therapies in various therapeutic areas, including neurological and neuromuscular diseases (DMD, SMA, etc.) since 1998. GEN manufactures high-quality, competitive products in its GMP-certified facility and pursues original drug development in two dedicated R&D centers and through investments. For more information, please visit www.genilac.com.tr .
For further information please contact:
Santhera
Catherine Isted, Chief Financial Officer:
IR@santhera.com
ICR Healthcare
Santhera@icrhealthcare.com
GEN
Deniz Karagulle, Chief Commercial Officer
d.karagulle@genilac.com
Bulutay Gunes, Head of Corporate Brand
b.gunes@genilac.com
Ali Ketencioglu, Investor Relations Manager
a.ketencioglu@genilac.com
Disclaimer / Forward-Looking Statements
This communication does not constitute an offer or solicitation to subscribe for or purchase securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements about the company and its business. Such statements involve certain risks, uncertainties and other factors that could cause the actual results, financial condition, performance or achievements of the company to differ materially from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly in connection with a contractual or investment decision. The company disclaims any obligation to update these forward-looking statements.
Source: globenewswire.com
