Abbvie and Regenexbio Agree to Develop and Commercialize Eye Disease Gene Therapy

Rothwell, Figg, Ernst & Manbeck, P.C.
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On September 13, 2021, Regenxbio, a Maryland biotech company, and AbbVie announced that they have entered an agreement to develop and commercialize a potential gene therapy drug developed by Regenxbio for treating age-related macular degeneration (wet AMD), diabetic retinopathy, and other chronic retinal diseases.

The gene therapy drug, RGX-314, is composed of Regenxbio’s proprietary NAV AAV8 vector encoding an antibody fragment capable of inhibiting vascular endothelial growth factor (VEGF).  In the retina, VEGF promotes undesired new blood vessel growth that causes the retinal diseases.  RGX-314 will treat the diseases by inhibiting VEGF activity.  Different from current treatments, which require repeated, even lifelong, intraocular injections, RGX-314 is a one-time therapy that offers a less burdensome treatment option for patients and care givers.  Regenxbio has obtained an exclusive license from Clearside Biomedical to use the SCS Microinjector® to deliver RGX-314 to the retina.  Regenxbio’s Phase 3 study in wet AMD uses subretinal injections, while its gene therapy is also involved in two Phase 2 clinical trials testing suprachoroidal delivery for wet AMD and diabetic retinopathy.

Regenxbio is a clinical-stage company developing multiple gene therapy candidates for treating retinal, metabolic, and neurodegenerative diseases.  The pipelines are based on Regenxbio’s proprietary NAV (novel AAV vectors) technology, an adeno-associated virus (AAV) platform for gene therapy delivery.  In addition to their internal pipelines, Regenxbio has also out-licensed the technology to third party companies (e.g., Novartis, Pfizer, and Eli Lilly) for developing other drug candidates.

Under the agreement with AbbVie, Regenxbio will receive a $370 million upfront fee and potential milestone payments of up to $1.38 billion.  Regenxbio will complete the ongoing clinical trials of RGX-314 and share the costs on additional trials with AbbVie.  AbbVie will be responsible for the global commercialization of RGX-314, and Regenxbio will focus on the U.S. market.  The two companies will share equally in profits from the sales of RGX-314 in the U.S.  For sales outside the U.S., Regenxbio will receive tiered royalties from AbbVie.

“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 CEO of Regenxbio.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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