Santhera exercises the option to obtain worldwide rights of Vamorolone in Duchenne muscular dystrophy and all other indications. Santhera will further discuss the option exercise in the conference call on the occasion of the publication of the First Half-year Results on September 8, 2020.
- License might give Santhera worldwide rights to vamorolone, now also including the major markets Japan and South Korea, and paves the way for partnering in additional indications
- Agreements with Idorsia and ReveraGen give Santhera immediate control over vamorolone and defer milestone-related payments
- Transaction establishes Santhera as a leading company in rare neuromuscular diseases with two late-stage assets addressing the medical need of DMD patients from early to late disease stages
Santhera announces that it has signed agreements with Idorsia (SIX: IDIA) and ReveraGen BioPharma Inc., making Santhera a direct license holder of vamorolone. Under the agreements, Santhera has obtained an exclusive license from ReveraGen, the originator of vamorolone, for all indications worldwide. The agreements create further value for Santhera through the transfer of rights for the previously excluded markets Japan and South Korea, the right to grant sublicenses and a share in the expected Priority Review Voucher.
Vamorolone, a first-in-class anti-inflammatory drug candidate with a novel mode of action, is currently being investigated in the pivotal Phase 2b VISION-DMD study in patients with Duchenne muscular dystrophy (DMD) by originator ReveraGen and completion of study enrollment is expected shortly.
Vamorolone, (also known as VBP15) is a ‘dissociative steroid’. This means that it retains sub activities associated with efficacy (trans repression, physicochemical membrane effects, synchronisation of tissue remodelling), and dissociates these efficacy-sub activities from other sub activities more associated with harmful side effect profiles (transactivation sub activity). Vamorolone has received Orphan Drug Designation in the US and Europe and is being developed for chronic treatment of boys with Duchenne Muscular Dystrophy (DMD).