The US Food and Drug Administration (FDA) has approved 鈥� Agamree (vamorolone) for treating Duchenne muscular dystrophy (DMD).
The approval has triggered $36m in licensing payments from , which holds licensing rights for marketing Aganree in North America. According to the agreement, Santhera is also in line to receive up to $105m in sales-based milestones and a percentage of royalties.
The $26m from the total payment will cover Santhera鈥檚 third-party milestone obligations, as per the 27 October . The company acquired the drug from Idorsia and ReveraGen BioPharma for approximately $17.9m in 2020. Catalyst will also assume Santhera’s third-party royalty obligations on Agamree North American sales in all indications.
The US launch of Agamree is planned for the first quarter of 2024. GlobalData forecasts the therapy to generate $216m in global sales in 2033.
GlobalData is the parent company of Pharmaceutical Technology.
DMD is a rare genetic disorder that is characterised by progressive muscle degeneration and weakness. It affects six in 100,000 individuals in Europe and North America, as per the Muscular Dystrophy Association.
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By GlobalDataThe FDA approval for Agamree is based on the along with the safety information from . In October, Agamree also received a positive opinion from the European Medicines Agency鈥檚 Committee for Medicinal Products for Human Use (CHMP) for its approval in the EU.
The first gene therapy for the DMD, 鈥� Elevidys (delandistrogene moxeparvovec-rokl), was also approved this year.
In July, Santhera divested global Raxone (idebenone) programme to while still being eligible for milestone-based payments from the drug sales.
Another drug in Santhera鈥檚 pipeline, lonodelestat, is a selective peptide inhibitor of human neutrophil elastase, which has orphan drug designations in the EU and US for treating cystic fibrosis, alpha-1 antitrypsin deficiency (AATD), and primary ciliary dyskinesia (PCD).
