Dicerna and Roche Partner on RNA Silencing for Hepatitis B in $1.67 Billion Deal

Hepatitis B

Cambridge, Massachusetts-based Dicerna Pharmaceuticals signed a research collaboration and licensing deal with Roche that could hit $1.67 billion. The companies will work to develop therapies for chronic hepatitis B virus (HBV) using Dicerna’s proprietary GalXC RNAi technology platform. They will work to develop and commercialize DCR-HBVS, a Dicerna therapy currently in Phase I clinical development.

Under the terms of the deal, Roche will pay Dicerna $200 million upfront and up to another $1.47 billion for various development, regulatory and commercial milestones. Dicerna will be eligible for royalties based on potential product sales of DCR-HBVS. Dicerna will keep an option to co-fund pivotal development of the product globally, which would entitle the company to enhanced royalties and to co-promote products, including DCR-HBVS in the United States.

“Dicerna is excited to collaborate with Roche to realize the full potential of DCR-HBVS and leverage our GalXC platform to target and silence specific genes that contribute to chronic hepatitis B virus infections,” said Douglas M. Fambrough, Dicerna’s president and chief executive officer.

Fambrough added, “With its deep expertise in HBV and established global infrastructure, Roche is ideally suited to help us accelerate the development and commercialization of DCR-HBVS, pursue a cure for chronic HBV infection, and address this serious global threat to public health.”

HBV affects more than 292 million people with chronic infections worldwide, according to the World Health Organization. Chronic HBV infection is marked by the presence of the HBV surface antigen or six months or more. About 800,000 people die from the liver infection each year globally; it is the primary cause of a type of liver cancer called hepatocellular carcinoma (HCC). It is the second-leading cause of cancer deaths worldwide.

DCR-HBVS uses RNA interference to knock down specific genes involved in creating HBV messenger RNA (mRNA) and entry of the virus into liver cells. In its research, Dicerna has found this leads to more than a 99.9% decrease in circulating HBV antigen (HBsAg) in mouse models.

A year ago in October, Eli Lilly and Company inked a deal with Dicerna to use the GalSC RNAi tech platform to focus on cardio-metabolic disease, neurodegeneration and pain. Under the terms of that deal, Lilly paid Dicerna an upfront payment of $100 million in addition to a $100 million equity investment at a premium. Dicerna is eligible for up to $350 million per target in various milestones in addition to tiered royalties from the mid-single to low-double digits on commercial products.

Dicerna is working with Lilly exclusively in the neurodegeneration and pain fields, and on select targets in cardio-metabolic diseases. They expect to collaborate on more than 10 targets.

RNAi is a very new development. The first RNAi therapy to be approved by the U.S. Food and Drug Administration (FDA) was Alnylam Pharmaceuticals’ Onpattro (patisiran), which was greenlighted in 2018 for the nerve damage caused by hereditary transthyretin amyloidosis.

Dicerna also has partnerships with Alexion Pharmaceuticals and Boehringer Ingelheim.

John Young, global head of Infectious Diseases at Roche Pharma Early Research & Development, of the new deal, said, “We are excited to engage in a clinical partnership and research collaboration with Dicerna. This partnership builds upon our existing portfolio and internal expertise and positions us well to develop a best-in-disease therapy to cure chronic HBV infection.”

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