AbbVie and REGENXBIO have formed a strategic partnership to jointly develop and commercialize RGX-314, an investigational gene therapy for wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases, the companies announced in a news release.
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 partnership, REGENXBIO will be in charge of completion of the ongoing trials of RGX-314. Both AbbVie and REGENXBIO are expected to 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.
Furthermore, AbbVie will be responsible for the clinical development and commercialization of RGX-314 around the globe while REGENXBIO will participate in commercialization efforts specifically in the U.S., according to a mutually agreed upon commercialization plan.
"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," said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie, said in the press release.
Under the terms of the agreement, AbbVie will initially pay a $370 million to REGENXBIO, and the potential investment cost is then estimated to increase up to $1.38 billion for additional development, regulatory and commercial milestones of RGX-314. Additionally, the companies will equally share the profits obtained from net sales of RGX-314 in the U.S.
The transaction, which is subject to regulatory approvals, is expected to close by the end of 2021.
AbbVie Inc. (AbbVie) is a research-based biopharmaceutical company, which focuses on research and development, manufacturing, commercialization and sale of medicines and therapies. The company offers various products across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology.
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. The company is engaged in the development of gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases.