Dutch gene therapy company uniQure (Nasdaq: QURE) and University of Massachusetts Medical School (UMMS) spin-out Apic Bio have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS.
Under the agreement, uniQure acquires global rights for the development and commercialization of APB-102, adding to its pipeline of gene therapies to treat neurological disorders. The US Food and Drug Administration has cleared the investigational new drug (IND) application for APB-102 and has granted Orphan Drug and Fast Track designations for the product.
uniQure will make an initial cash payment of $10 million. uniQure will also pay Apic Bio up to $45 million in milestones on the achievement of regulatory approvals in the USA and Europe and pre-specified annual net sales, as well as a tiered royalty on net sales ranging from the mid-single digits to low double digits.
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