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 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.
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. 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.
Worldwide, 2 billion people – or one out of three – are infected with HBV, and more than 250 million people are chronically infected, including 1 to 2 million people in the U.S. An estimated 1 million people die each year from HBV and its complications worldwide, of whom about 5,000 are in the U.S. Worldwide, chronic infection with hepatitis causes 80 percent of all cases of hepatocellular carcinoma (HCC), which kills more than 500,000 people each year. (Source: Alnylam Website, October 18, 2017)