Santhera Pharmaceuticals Signs Exclusive Agreement with Gen for the Distribution of AGAMREE in Turkey

Santhera Pharmaceuticals has signed an exclusive agreement with GEN to distribute and market AGAMREE (Vamorolon) in Turkey for treating Duchenne muscular dystrophy (DMD) in patients over four years old. GEN will begin supplying and selling AGAMREE on a named-patient basis in the first half of 2026, followed by commercial distribution. Santhera has received a small upfront payment and will receive a continuing percentage of net sales.

Santhera Pharmaceuticals (SIX: SANN), a Swiss specialty pharmaceutical company, has entered into an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN) to distribute and market AGAMREE (Vamorolon) in Turkey. The agreement aims to provide access to AGAMREE for the treatment of Duchenne muscular dystrophy (DMD) in patients aged four and above.

Under the terms of the agreement, GEN will commence supplying and selling AGAMREE on a named-patient basis in the first half of 2026, followed by commercial distribution. Santhera has received a small upfront payment and will receive an ongoing percentage of net sales as per previous agreements.

Dario Eklund, Chief Executive Officer of Santhera, stated, "As leaders in the Turkish specialty pharmaceuticals market, GEN were a natural choice for Santhera as we looked for a high-quality distribution partner. We look forward to working closely in the run-up to launching in the country in 2026, to provide access to the many DMD patients lacking suitable treatment options."

Abidin Gülmüş, Chairman/CEO of GEN, added, "The potential for AGAMREE is clear, and we are determined to ensure this DMD therapy reaches patients in Türkiye without delay. We understand the rare disease market deeply, use our longtime experience on neuromuscular diseases, and look forward to partnering with Santhera in the months and years ahead."

AGAMREE is a novel drug that binds to the same receptor as glucocorticoids but modifies its downstream activity. It is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes, which may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues. This mechanism has shown the potential to 'dissociate' efficacy from steroid safety concerns, positioning AGAMREE as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD.

In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile. The most commonly reported side effects were cushingoid features, vomiting, weight increase, and irritability, generally of mild to moderate severity.

Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers.

Santhera Pharmaceuticals, with its focus on developing and marketing innovative medications for rare neuromuscular diseases, has secured AGAMREE for various markets worldwide, including the United States, Europe, China, and certain countries in Southeast Asia.

References:
[1] https://www.globenewswire.com/news-release/2025/08/13/3132279/0/de/Santhera-schlie%C3%9Ft-Vereinbarung-mit-GEN-%C3%BCber-den-Vertrieb-von-AGAMREE-Vamorolon-in-der-T%C3%BCrkei.html
[2] https://www.globenewswire.com/news-release/2025/08/13/3132279/0/en/Santhera-Secures-Agreement-with-GEN-for-the-Distribution-of-AGAMREE-Vamorolone-in-T%C3%BCrkiye.html