Santhera and Catalyst Pharmaceuticals sign $231m license and collaboration deal

James Spargo | June 20, 2023 | News story | Medical Communications Catalyst Pharmaceuticals, Rare Diseases, Vamorolone, licence and collaboration, santhera 

Swiss specialty pharmaceutical company Santhera and US-based biopharmaceutical company Catalyst Pharmaceuticals have announced that they have signed an exclusive license and collaboration agreement for Duchenne muscular dystrophy (DMD) drug vamorolone.

Vamorolone has a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity, classing it as a dissociative anti-inflammatory drug. It has been granted Orphan Drug Designation (ODD) in the US and UK, received Fast Track and Rare Pediatric Disease designations by the US Food and Drug Administration (FDA) and been given Promising Innovative Medicine (PIM) status from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Under the agreement, Catalyst will have exclusive commercialisation rights to vamorolone in the US, Canada and Mexico, paying Santhera $75m upfront. Catalyst will also make an equity investment of $15m, and once the FDA approves vamorolone (expected in October 2023), it will pay Santhera another $36m. There is also scope for a further $105m in sales-based milestones, bringing the total to a potential $231m. Santhera will then use these proceeds to commercialise vamorolone in Europe.

Dario Eklund, CEO of Santhera, commented: “DMD 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. We believe Catalyst is well placed to maximise the value of vamorolone and, subject to regulatory approval, ensure patients in North America receive this transformational therapy as quickly as possible. Catalyst has a track record of success in the rare disease and neuromuscular space and is our commercial partner of choice for North America with an established infrastructure and commitment to patients. With our new partner, we also look forward to jointly address 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.”

James Spargo

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