Regenxbio will receive an upfront payment of $370m, along with an additional up to $1.38bn in potential milestone payments


AbbVie Corporate Headquarters. (Credit: AbbVie Inc.)

AbbVie has teamed up with biotechnology firm Regenxbio to develop and commercialise the latter’s investigational gene therapy RGX-314.

RGX-314 is intended for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases.

Under the terms of the partnership agreement, Regenxbio will receive an upfront payment of $370m from AbbVie.

It is also eligible to receive up to $1.38bn in milestone payments, in addition to tiered royalties on net sales of RGX-314 outside the US.

The transaction is expected to be completed by the end of 2021, subject to certain customary closing conditions, including regulatory approvals.

AbbVie R&D senior vice president, chief scientific officer Tom Hudson said: “We are committed to finding solutions for patients living with difficult-to-treat retinal diseases and to helping preserve and protect our patients from visual impairment and devastating vision loss.

“In collaboration with REGENXBIO, we aim to make a remarkable impact for the millions of patients suffering from vision loss associated with retinal diseases.”

Under the collaboration, the two companies have agreed to equally share costs on additional trials and profits from net sales of RGX-314 in the US.

Regenxbio will complete the ongoing trials of RGX-314, and lead the manufacturing of the drug for clinical development and commercial supply in the US.

AbbVie will manufacture RGX-314 for commercial supply outside the US, and lead the clinical development and commercialisation worldwide.

Regenxbio is studying RGX-314 in two different routes of administration to the eye, a standardized subretinal delivery, and the suprachoroidal delivery.

The company has licensed certain exclusive rights to the SCS Microinjector from Clearside Biomedical to deliver gene therapy treatments to the suprachoroidal space of the eye.

Under the mutually agreed commercialisation plan, Regenxbio is expected to undertake commercialisation efforts in the US.

Regenxbio president and chief executive officer Kenneth T Mills said: “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.”