Drug Research
Drug Discovery & Development

Alnylam, Vir to jointly advance RNAi therapeutics for infectious diseases

Published 20 October 2017

Alnylam Pharmaceuticals has announced an exclusive licensing agreement with Vir Biotechnology for the development and commercialization of RNAi therapeutics for infectious diseases, including chronic hepatitis B virus (HBV) infection.

As part of this agreement, the companies will advance Alnylam's HBV program and 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.

"This agreement represents another step toward bringing RNAi therapeutics to patients with limited or inadequate therapeutic options. Partnering with the exceptional, experienced team at Vir to advance investigational RNAi therapeutics in infectious diseases will expedite the development path for these medicines, while enabling Alnylam to maintain operational focus on our robust pipeline of later-stage programs," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "We believe the innovative structure of this deal, including the right for Alnylam to opt into a profit-sharing arrangement prior to the start of Phase 3 for HBV, gives us both strategic flexibility in our committed spend and retention of significant product value."

"We are excited to partner with Alnylam to bring scientific innovation to infectious diseases, such as hepatitis B, that impact global health and currently have significant unmet needs," said George Scangos, Ph.D., Chief Executive Officer of Vir. "This collaboration is a key step forward toward our goal of leveraging discovery and development to better control, or even cure, infectious diseases, thereby benefitting those patients most in need around the world."

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.

Under the terms of the agreement, 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 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.

Source: Company Press Release