Pratteln, Switzerland — October 3, 2025 — Leads & Copy —Santhera Pharmaceuticals (SIX: SANN) announced today that Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older. This marks the first approved treatment for the disease in Canada, following a Priority Review.
Kye Pharmaceuticals holds exclusive Canadian commercial rights to AGAMREE for the treatment of DMD and potentially other indications, following a sub-license agreement with Santhera’s commercialization partner Catalyst Pharmaceuticals, Inc. Santhera will receive royalties on Canadian sales, contributing to North American sales milestones payable from its partner Catalyst.
The Canadian Neuromuscular Disease registry estimates that there are more than 800 boys and young men living with DMD in Canada and coping with its debilitating symptoms.This is the sixth independent approval by a local health authority, following positive regulatory decisions in the U.S., Europe, the UK, China and Hong Kong.
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. It has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids.
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. Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth and no negative effects on bone metabolism.
For further information please contact:
Santhera
Catherine Isted, Chief Financial Officer
IR@santhera.com
ICR Healthcare
Santhera@icrhealthcare.com
Source: Santhera Pharmaceuticals
