Pharma Focus Asia

UniQure and Apic Bio Enter Licencing Agreement for APB-102

Tuesday, January 31, 2023

UniQure N.V and Apic Bio announced that they have entered into a global licencing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS.

Under the agreement, uniQure will acquire worldwide rights to develop and commercialise of APB-102, adding to its pipeline of gene therapies for neurological disorders. The U.S. Food and Drug Administration has cleared the investigational new drug (IND) application for APB-102 and has granted Orphan Drug and Fast Track designations.

With this agreement, uniQure will make an initial cash payment of $10 million. In addition, uniQure will pay Apic Bio $45 million in milestone payments based on regulatory approvals and predetermined annual sales in the US and Europe, as well as a graduated royalty on sales from mid-single digits to low double digits.

The licencing of APB-102 provides uniQure a second clinical phase programme which is strategically aligned with the current pipeline and complement AMT-161 programme for the treatment of ALS caused by mutations in the c9orf72 gene.

The APB-102 licence further strengthens uniQure's line of innovative gene therapies for neurological diseases and miRNA-based gene silencing programmes.

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