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AbbVie signs gene therapy deal in eye care

AbbVie and REGENXBIO have teamed up on RGX-314, a potential one-time gene therapy against two leading causes of blindness, wet AMD and diabetic retinopathy.

AbbVie and REGENXBIO have formed a strategic partnership to develop and commercialise a potential gene therapy for wet age-related macular degeneration (AMD), diabetic retinopathy (DR) and other chronic retinal diseases.

Under the deal, REGENXBIO will receive a large upfront payment of $370m and up to $1.38bn in development, regulatory and commercial milestones. If the candidate gains approval, the companies will share equally in profits from net sales in the US andAbbVie will pay tiered royalties on net sales in the rest of the world.

Shares in REGENXBIO rose more than 20% on the news.

RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF), part of the pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.

The potential therapy has two potential routes of administration to the eye, the more standard subretinal delivery procedure and delivery to the suprachoroidal space via the SCS Microinjector, which can be done under local anaesthetic.

RGX-314 is currently being tested in a pivotal trial for wet AMD using subretinal delivery and two separate phase II clinical trials using in-office suprachoroidal delivery for patients with wet AMD and DR.

AbbVie was a “strong, complementary partner” for REGENXBIO said its president and CEO, Kenneth T Mills. “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," he said.

Under the deal, REGENXBIO will be responsible for ongoing trials of RGX-314 then the companies will

collaborate and share costs on additional trials. Later, AbbVie will lead the clinical development and commercialization of RGX-314 globally while REGENXBIO will partner in commercialising the therapy in the US. On the manufacturing side, REGENXBIO will manage supplies for clinical development and the commercial supply in the US, and AbbVie will lead for commercial supply outside the US.

Wet AMD – a significant cause of vision loss affecting up to two million people in the United States, Europe and Japan – is treatable with current anti-VEGF therapies but these require lifelong repeated treatment and patients can experience a decline in vision over time.

DR is the leading cause of vision loss in adults between 24 and 75 years of age worldwide, with current treatment options including "watchful waiting", anti-VEGF treatment, retinal laser or surgical treatment.

Article by
Hugh Gosling

14th September 2021

From: Sales, Healthcare



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