Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico.
Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region.
The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.
In the US and Europe, the drug has received orphan drug status to treat Duchenne muscular dystrophy (DMD).
The US Food and Drug Administration (FDA) has now granted fast-track and rare paediatric disease designations, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted promising innovative medicine status to vamorolone for DMD.
Santhera Pharmaceuticals will receive an upfront payment of $90m: $75m in cash and $15m in equity investment.
The company will receive an additional $10m upon approval from the US FDA for vamorolone for DMD treatment.
Santhera will also receive $26m for making payments of contractually agreed third-party regulatory milestone obligations, and $105m in potential sales milestones.
Santhera CEO Dario Eklund stated: “Duchenne muscular dystrophy is a devastating condition. Everyone at Santhera has been working diligently to advance vamorolone in order to make this important treatment option available to patients.
“With our new partner, we also look forward to jointly addressing the benefits of vamorolone in additional indications.
“As part of this agreement, Santhera benefits from upfront, milestone and royalty payments, which allows us to focus on the commercial roll-out of vamorolone in DMD and future other indications in Europe.”
The company intends to commercialise vamorolone in key European locations, including the UK, Italy, Germany, France, Spain and the Benelux countries.
The new drug application for the drug to treat DMD is currently under review in the US.
The US FDA has assigned 26 October 2023 as the Prescription Drug User Fee Act (PDUFA) date for its decision.
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