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IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.
In a June 17, 2019 press statement, IVERIC bio and Catalent Biologics have announced they have entered into a strategic manufacturing agreement for the production and manufacture of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio’s gene therapy product candidates to treat orphan inherited retinal diseases.
Under the terms of the agreement, IVERIC bio has employed Paragon Gene Therapy, which is a part of Catalent Biologics, to provide materials for preclinical activities and the planned Phase I/II clinical trials for IC-100-which is aimed at treating rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP)-and IC-200-for the treatment of BEST1 related retinal diseases.
“We fully appreciate the importance of having a world-class manufacturing infrastructure in place as we continue to build and advance our gene therapy pipeline for inherited retinal diseases,” said Glenn P. Sblendorio, chief executive officer and president of IVERIC bio. “Our relationship with Catalent secures access to manufacturing capabilities and capacity that we believe will enable us to enter into the next phase of gene therapy development with our product candidates IC-100 for RHO-adRP and IC-200 for BEST1 related retinal diseases.”
“We are extremely pleased to partner with IVERIC bio as they advance their portfolio of AAV gene therapies for orphan inherited retinal diseases,” added Pete Buzy, president of Paragon Gene Therapy. “We look forward to a strong relationship with the goal of achieving IVERIC bio’s gene therapy AAV manufacturing milestones for the production of clinical material.”