IVERIC bio Enters Strategic Manufacturing Relationship With Catalent's Paragon Gene Therapy

IVERIC bio, Inc. and Catalent Biologics recently announced they have entered into an agreement for production and manufacturing 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 clinical trials for IC-100 in 2020 and IC-200 in the first half of 2021. 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,” stated 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.”

“We believe that AAV gene therapy is the future of drug development for orphan inherited retinal diseases,” stated Keith Westby, Chief Operating Officer of IVERIC bio. “When building a gene therapy franchise the selection of an experienced manufacturer is a critical component. We believe Paragon’s specialized expertise in AAV vector manufacturing and the addition of their new world-class commercial-scale facility will positively impact the advancement of our gene therapy pipeline. We look forward to collaborating closely with the Paragon team.”

IVERIC bio is a biotechnology company with a focus on the discovery and development of novel gene therapy solutions to treat orphan inherited retinal diseases with unmet medical needs. Vision is Our Mission. For more information on the Company’s gene therapy and other programs, please visit www.ivericbio.com.

In May 2019, Catalent, Inc. announced that it had completed the $1.2 billion acquisition of Paragon Bioservices, Inc., a leading viral vector development and manufacturing partner for gene therapies. Paragon’s unique and differentiated scientific, development, and manufacturing capabilities, will fundamentally enhance Catalent’s biologics business and end-to-end integrated biopharmaceutical solutions and allow Catalent to capitalize on strong industry tailwinds in the potentially $40 billion addressable market for gene therapies.

Catalent is the leading global provider of advanced delivery technologies, and development and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.