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AbbVie and RegenxBio announce eye care collaboration for RGX 314.

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Last updated:24th Sep 2021
Published:14th Sep 2021
AbbVie and RegenxBio Inc. announced a partnership to develop and commercialize RGX 314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases.

RGX 314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery.

Under the collaboration, RegenxBio will be responsible for completion of the ongoing trials of RGX-314. AbbVie and RegenxBio will collaborate and share costs on additional trials of RGX 314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX 314 globally. RegenxBio shall participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.

Under the terms of the agreement, AbbVie will pay RegenxBio a $370 million upfront payment with the potential for RegenxBio to receive up to $1.38 billion in additional development, regulatory and commercial milestones. RegenxBio and AbbVie will share equally in profits from net sales of RGX 314 in the U.S. AbbVie will pay RegenxBio tiered royalties on net sales of RGX 314 outside the U.S. In addition, RegenxBio will lead the manufacturing of RGX 314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of RGX 314 for commercial supply outside the U.S.

Condition: Age Related Macular Degeneration
Type: drug