Santhera plan to repay its debt of CHF 29m ($33.8m) to Highbridge Capital and fund the pre-commercialization and launch of vamorolone in Europe. Image Credit: TRADOL / Shutterstock.

Santhera Pharmaceuticals has signed an exclusive licensing agreement with Catalyst Pharmaceuticals for the North American commercialisation of vamorolone, an investigational therapy for Duchenne muscular dystrophy (DMD).

Santhera has developed vamorolone in collaboration with ReveraGen BioPharma. The drug is currently an approval decision with a US Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) review date set for 26 October 2023. Vamorolone has an Orphan Drug status in the US and EU, along with a Promising Innovative Medicine (PIM) status in the UK for treating DMD.

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Vamorolone acts by binding to glucocorticoid receptors, thereby, modifying disease activity while reducing the adverse effects from the standard steroid therapy.

The agreement with Catalyst is worth up to $231m plus sales royalties for Santhera. Of these, $75m will be an upfront cash payment, with $15m in treasury shares sale to Catalyst. Additional milestone-based payments include $26m for Santhera’s third-party regulatory and royalty obligations and $105m in sales-based milestones.

Santhera plan to repay its debt of SFr29m ($33.8m) to Highbridge Capital and fund the pre-commercialisation and launch of vamorolone in Europe. The first European launch is expected later this year in Germany.

Santhera plans to launch the drug in the five largest European countries plus Benelux, the economic region of Belgium, the Netherlands, and Luxembourg, by itself, and is looking for partnerships in other regions, except US and China where it has existing partnerships.

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In June 2023, the FDA granted accelerated approval for the first-ever gene therapy for DMD, Elevidys (delandistrogene moxeparvovec-rokl) by Sarepta Therapeutics.

Vamorolone is also under investigation for Becker muscular dystrophy in a US FDA-funded Phase II pilot study (NCT05166109).

Other drugs in the Santhera pipeline include lonodelestat, which was leased from Polyphor AG for development and commercialisation in cystic fibrosis (CF), alpha-1 antitrypsin deficiency (AADT), primary ciliary dyskinesia (PCD), and other lung diseases. It is currently under regulatory review with orphan drug status in the US and EU for CF, AADT, and PCD.