Santhera Launches AGAMREE (Vamorolone) in Germany as First Market for the Treatment of Duchenne Muscular Dystrophy

• AGAMREE is the only approved medication in the European Union (EU) for treating all patients from age 4 years with DMD, and the first DMD treatment approved across the U.S., EU and UK
• This marks the first commercial launch of AGAMREE globally

Pratteln, Switzerland, January 15, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the launch of AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, irrespective of the underlying mutation and ambulatory status, in Germany.

AGAMREE is the first and only medicinal product for DMD to have received full approval in the EU and, following approval in the U.S. last October and in the UK last week, it is the first authorized treatment for patients with the disease in all three territories.

“We are very happy that AGAMREE is now commercially available in Germany, the first country worldwide, for the treatment of DMD,” said Dario Eklund, CEO of Santhera. “This significant milestone represents Santhera’s commitment to fill the unmet need in DMD and provide a safe and effective treatment for DMD patients. For Santhera, this launch signifies a leap forward as the Company enters the commercial stage. In parallel, we continue to work towards our own staged commercial roll-out in the large European markets, alongside ongoing discussions with distribution partners for other regions.”

Silvia Hornkamp, Managing Director of the German Duchenne Foundation, commented: “We are delighted that Santhera has been investing in Duchenne research for so many years. Now the time has come—with the new drug AGAMREE, patients suffering from Duchenne muscular dystrophy have access to a better tolerated alternative to steroids. It is a benefit for the sick children, who until now have been burdened with many side effects due to the long-term use of steroids.”

This launch follows the European Commission’s approval of AGAMREE on December 18, 2023, for all 27 EU member states as well as Iceland, Liechtenstein, and Norway. As part of the marketing authorization, the European Medicines Agency (EMA) acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy. Patients treated with AGAMREE or placebo showed normal and similar growth while growth stunting was observed in children treated with prednisone. In addition, patients who switched from a standard of care corticosteroid to AGAMREE maintained the efficacy benefit while recovering their growth and bone health.