RNAi therapeutics company Alnylam Pharmaceuticals, Inc. (ALNY) announced Wednesday a licensing agreement with Vir Biotechnology for the development and commercialization of RNAi therapeutics for infectious diseases, including chronic hepatitis B virus or HBV infection.
Under the deal terms, Alnylam will receive an upfront payment, comprised of cash and shares of Vir common stock. Alnylam is also eligible to receive more than $1 billion in potential milestone payments. This is related to the successful advancement of ALN-HBV02 and other infectious disease programs, as well as tiered royalties on products ultimately commercialized by Vir under the collaboration, should Alnylam elect to decline its co-development and profit share option on a per-product basis.
Vir Biotechnology is focused on the care of people with serious infectious diseases.
As part of this agreement, the companies will advance Alnylam's HBV program. They will also initiate a research collaboration for the development and advancement of up to four additional RNAi therapeutic programs for the treatment of other infectious diseases with high unmet needs.
Alnylam is developing ALN-HBV for the treatment of chronic HBV infection. A Phase 1/2 clinical trial of ALN-HBV was initiated in July 2016. Alnylam plans to discontinue further development of this investigational compound and to advance a new Development Candidate, ALN-HBV02, utilizing the Company's Enhanced Stabilization Chemistry-Plus (ESC+) GalNAc conjugate technology.
As recently reported, ESC+ conjugates have the potential to improve target specificity with an expanded therapeutic index.
As part of the agreement, Alnylam will lead ALN-HBV02 to IND filing, with Vir then progressing ALN-HBV02 through human proof of concept (POC); the companies will co-fund the program through this point.
Subsequently, Vir will fund and conduct all development through completion of Phase 2 studies. Thereafter, Alnylam retains the right to opt into a profit-sharing arrangement prior to the start of Phase 3.
In connection with the companies' research collaboration for up to four additional infectious disease programs, Vir will fund all research and development costs, while Alnylam retains a product-by-product option on each program to opt into a profit-sharing arrangement following human POC.
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