REGENXBIO Inc. (Nasdaq: RGNX), a US-based clinical-stage biotechnology company, announced on Tuesday that it has completed its Collaboration and License Agreement with United States-based AbbVie.
The contract has been signed 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.
According to the terms of the agreement, REGENXBIO will receive an upfront payment from AbbVie of USD370m with the potential for REGENXBIO to receive up to USD1.38bn in additional development, regulatory and commercial milestones. Under the partnership, REGENXBIO is to manage the completion of the ongoing trials of RGX-314. Both firms will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial assessing subretinal delivery to treat wet AMD and future trials. AbbVie is to head the clinical development and commercialisation of the product globally. REGENXBIO is to participate in United States commercialisation efforts as offered under a mutually agreed upon commercialisation plan. Both parties will share equally in profits from net sales of RGX-314 in the United States and AbbVie is to pay REGENXBIO tiered royalties on net sales of RGX-314 outside the United States. REGENXBIO is to head the production of RGX-314 for clinical development and United States commercial supply, and AbbVie is to lead production of RGX-314 for commercial supply outside the United States.
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