Catalent Biologics, IVERIC bio Ink Mfg. Pact

 IVERIC bio, Inc. and Catalent Biologics, have entered into an agreement for production and manufacture of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio’s gene therapy product candidates, IC-100 for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP) and IC-200 for the treatment of BEST1 related retinal diseases. IVERIC bio expects to initiate Phase 1/2 trials for IC-100 in 2020 and IC-200 in 1H21. IVERIC bio has engaged Paragon Gene Therapy, part of Catalent Biologics, to provide materials for preclinical activities and its planned Phase 1/2 clinical trials for both product candidates.

"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 Mr. Glenn P. Sblendorio, chief executive officer and president of IVERIC bio. "Our relationship with Catalent secures access to state-of-the-art 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."

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