AbbVie and REGENXBIO have partnered to develop and commercialise 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 utilising subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilising 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 commercialisation of RGX-314 globally. REGENXBIO shall participate in US commercialisation efforts as provided under a mutually agreed upon commercialization plan.
“AbbVie is a strong, complementary partner for REGENXBIO. We expect to leverage AbbVie’s global developmental and commercial infrastructure within eye care with our expertise in AAV gene therapy clinical development and deep in-house knowledge of manufacturing and production to continue the development of RGX-314,” said Kenneth T. Mills, president and chief executive officer of REGENXBIO.
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.