Comparable long-term effectiveness to standard of care corticosteroids over 5 years Normal growth maintained, in contrast to growth suppression commonly seen with standard of care corticosteroids Significantly lower rate of vertebral fractures reported with AGAMREE Lower incidence of cataracts than normally seen for DMD patients on corticosteroids Pratteln, Switzerland, November 4, 2025 – Santhera Pharmaceuticals (SIX: SANN) today reported positive topline results from an analysis of long-term data, includ ...

Pratteln, Switzerland, October 9, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Biomedica for the distribution of AGAMREE® (vamorolone) in Russia, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. Under the terms of the agreement, Santhera will receive a percentage of net sales, in line with previous distribution agreements, with sales expected to begin in Q1 2026. This collaboration will enable access to AGAMRE ...

Pratteln, Switzerland, 29 August, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Ikris Pharma Network (Ikris) to manage the distribution of AGAMREE® (vamorolone) in India, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. The agreement between Santhera and Ikris has a 5-year term and Santhera will receive a percentage of net sales, in line with previous distribution agreements. Sales are expected to begin in Q4 2 ...

合作协议签署 - Santhera Pharmaceuticals与Gen İlaç ve Sağlık Ürünleri San ve Tic AŞ (GEN) 签署独家协议 在土耳其分销和推广AGAMREE® (vamorolone) 用于治疗4岁及以上杜氏肌营养不良症(DMD)患者 [1] - 供应和销售预计2026年上半年启动 初期以指定患者为基础 后续转为商业销售 [1] - Santhera获得小额预付款 并将持续获得净销售额的分成 [1] 合作方背景与战略意义 - GEN是土耳其专业制药市场领导者 专注于神经及神经肌肉疾病领域(如DMD SMA) 拥有GMP认证设施和研发中心 [10] - Santhera认为GEN是高质量分销合作伙伴的自然选择 双方将密切合作为2026年上市做准备 [2] - GEN强调深刻理解罕见病市场 利用神经肌肉疾病长期经验 决心确保AGAMREE及时惠及土耳其患者 [2] 产品特性与临床数据 - AGAMREE是一种新型解离性类固醇抗炎药 作用机制与糖皮质激素相同受体结合但改变下游活性 可能将疗效与类固醇安全性问题"解离" [3] - 在关键VISION-DMD研究中 AGAMREE在24周治疗时达到主要终点TTSTAND速度优于安慰剂(p=0002) 显示良好安全性和耐受性 [4] - 最常见副作用为库欣样特征 呕吐 体重增加和烦躁 严重程度一般为轻度至中度 [4] - 现有数据显示AGAMREE不同于皮质类固醇 没有生长限制 对骨代谢无负面影响 骨形成和骨吸收血清标志物正常 [5] 公司背景与全球布局 - Santhera是瑞士专业制药公司 专注于未满足医疗需求高的罕见神经肌肉疾病创新药物开发和商业化 [7] - 拥有AGAMREE全球所有适应症的独家许可 该药物已获美国FDA 欧盟EMA 英国MHRA 中国NMPA和香港卫生署批准用于DMD治疗 [7] - Santhera已将AGAMREE在北美权利授权给Catalyst Pharmaceuticals 在中国及部分东南亚国家权利授权给Sperogenix Therapeutics [9]