uniQure N.V. and Apic Bio, a gene therapy company developing novel treatment options for patients with rare genetic diseases, announced that they have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 amyotrophic lateral sclerosis, 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 U.S. Food and Drug Administration has cleared the investigational new drug application for APB-102 and has granted Orphan Drug and Fast Track designations. "The licensing of APB-102 provides uniQure with another clinical stage program that is strategically aligned with our current pipeline and highly complementary with our AMT-161 program for the treatment of ALS caused by mutations in the c9orf72 gene," stated Ricardo Dolmetsch, Ph.D. president of research and development at uniQure. "Together, these ALS gene therapy candidates have the potential to address most familial forms of ALS and transform the lives of thousands of patients around the world suffering from this devastating disease. We look forward to initiating a Phase I/II clinical study of APB-102 in the second half of 2023." Under the terms of the agreement, uniQure will make an initial cash payment of $10 million. In addition, uniQure will pay Apic Bio up to $45M in milestones upon achievement of regulatory approvals in the U.S. and Europe and pre-specified annual net sales, and a tiered royalty on net sales ranging from the mid-single digits to low double digits.
Published first on TheFly
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