IVERIC bio, Inc. and DelSiTech Ltd, announced an exclusive global license agreement providing Iveric Bio with the right to develop and commercialise new formulations of Zimura (avacincaptad pegol) using DelSiTech’s silica-based sustained release technology.
Key highlights:
- Iveric Bio is an biopharmaceutical company committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD).
- An agreement has been signed that grants Iveric Bio exclusive rights to develop and commercialise new formulations of Zimura using DelSitech's silica-based sustained release technology.
- The terms of the agreement are that Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products.
- Zimura is a chemically synthesised RNA aptamer and amendable to injectable sustained release formulations.
- President of Iveric, Pravin U. Dugel, believes that post-hoc analyses of Zimura suggest that it may have the potential to impact AMD in early stages before atrophy occurs in patients.
- Iveric plans to initiate a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022, which is subject to global regulatory feedback from the FDA and other regulatory authorities and is to be obtained before initiating this trial.
As part of Iveric Bio’s lifecycle expansion plan for Zimura, the company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies potentially could address patients being treated for geographic atrophy (GA) secondary to dry AMD and intermediate AMD.
“We are thrilled to collaborate with the DelSiTech team on investigating additional sustained release formulations for Zimura with their drug delivery expertise and advanced technology and look forward to evaluating a sustained release formulation in GA and potentially earlier stages of AMD,” stated Pravin U. Dugel, MD, president of Iveric Bio.
“Previously reported post-hoc analyses from GATHER1 suggest that Zimura may have the potential to impact AMD in early stages before atrophy occurs in patients. We believe Zimura, which is a chemically synthesised RNA aptamer, is amendable to injectable sustained release formulations.”
“As a leading developer of long-acting controlled release formulations for small molecules and biological entities, we are excited about collaborating with Iveric Bio on bringing innovative solutions to patients living with AMD,” stated Lasse Leino, PhD, chief executive officer of DelSiTech. “We are inspired by the opportunity to leverage our drug delivery technology to potentially help AMD patients early and improve their treatment experience.”
“This agreement underscores our commitment to invest in lifecycle initiatives for Zimura,” said Glenn P. Sblendorio, chief executive officer of Iveric Bio. “We are excited about the possibilities to expand Zimura into earlier stages of AMD and potentially allow for a next-generation treatment to help patients with GA.”
“We are proud to bring our competencies into this promising alliance and contribute to Iveric Bio’s mission to address unmet needs for patients,” said Dr. Frederic Dargelas, head of Business Development and Alliance Management.
Under the terms of the license agreement, Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products.
In addition to working with DelSiTech, Iveric Bio plans to explore the potential for Zimura in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022. The development strategy in this indication is subject to global regulatory feedback from the FDA and other regulatory authorities, which is to be obtained before initiating this trial.