AbbVie, Regenxbio in $1.75-Bn Pact for Eye-Care Gene Therapy

AbbVie and Regenxbio, a Rockville, Maryland-based bio/pharmaceutical company, have entered into a partnership to develop and commercialize Regenxbio’s RGX-314, a gene therapy for chronic retinal diseases, in a deal worth up to $1.75 billion ($370 million upfront and up to up to $1.38 billion in milestone payments).

RGX-314, in Phase I development, is an investigational one-time gene therapy for treating wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 consists of an adeno-associated virus vector (NAV AAV8), which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF).

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

Under 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 US. AbbVie will pay Regenxbio tiered royalties on net sales of RGX-314 outside the US. In addition, Regenxbio will lead the manufacturing of RGX-314 for clinical development and US commercial supply, and AbbVie will lead manufacturing of RGX-314 for commercial supply outside the US.

The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.

Source: AbbVie and Regenxbio