Strategic Alliance Formed to Advance RNAi Therapeutics for Infectious Diseases

Alnylam Pharmaceuticals, Inc. recently announced an exclusive licensing agreement with Vir Biotechnology for the development and commercialization of RNA Interference (RNAi) therapeutics for infectious diseases.

Included in the agreement, the companies will progress Alnylam’s hepatitis B virus program and begin a research collaboration for the development and advancement of up to four additional RNAi therapeutic programs for the treatment of other infectious diseases with unmet medical needs.

Hepatitis B virus attacks the liver and is often transmitted via blood, semen, or other bodily fluids from person-to-person. For some individuals, HBV is short-term, however, it can become chronic in others. A chronic infection can result in severe health issues, including cirrhosis and liver cancer. The Centers for Disease Control and Prevention (CDC) estimates that approximately 20,000 hepatitis B infections occur annually in the United States, with the majority presenting in adults.

“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, PhD, chief executive officer of Alnylam in a press release. "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.”

ALN-HBV, a therapy for the treatment of chronic HBV infection is currently in development. In July 2016, the company initiated a phase 1/2 clinical trial of ALN-HBV which has since been discontinued in light of the development of a new candidate: ALN-HBV02. As part of the agreement, Alynlam will lead ALN-HBV02 to file for an Investigational New Drug (IND) application with the US Food and Drug Administration and then Vir will progress it through human proof of concept (POC). Following the action with the FDA, Vir has agreed to fund and conduct all development through completion of phase 2 studies, and Alnylam will retain the right to opt into a profit-sharing arrangement prior to the start of phase 3.

Pending the successful advancement of ALN-HBV02 and other infectious disease programs, Alnylam is eligible to receive more than $1 billion in potential milestone payments.