New Collaboration Intended to Advance RNAi Therapeutics for Infectious Diseases

Mathew Shanley

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

Among the diseases in the forefront is chronic hepatitis B (HBV) infection, and included in the agreement, the companies will progress Alnylam’s HBV program and begin a research collaboration for the development and advancement of up to 4 additional RNAi therapeutic programs for the treatment of other infectious diseases with unmet medical needs.

Hepatitis B is a life-threatening infectious disease that affects the liver and can become chronic, leading to cirrhosis and hepatocellular carcinoma. In the United States, the Centers for Disease Control and Prevention (CDC) estimates that approximately 20,000 hepatitis B infections occur annually, with the majority presenting in adults.

The virus is transmitted when blood, semen, or another body fluid from a person infected with it enters the body of someone who is not infected.

“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 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.”

Currently in development from Alnylam is ALN-HBV, a therapy for the treatment of chronic HBV infection. In July 2016, the company initiated a Phase 1/2 clinical trial of ALN-HBV which has since been discontinued in favor of the continued development of a new candidate, ALN-HBV02. As part of the agreement, Alynlam will lead ALN-HBV02 to filing for an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) and then 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.

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