Roche pays $200 million upfront as part of pact with Dicerna to develop RNAi therapies for hepatitis B

Roche agreed to pay $200 million upfront as part of a deal with Dicerna Pharmaceuticals potentially worth over $1.5 billion to develop RNA interference (RNAi) therapies for hepatitis B, including the early-stage drug DCR-HBVS, the companies reported Thursday. John Young, global head of infectious diseases at Roche Pharma Early Research & Development, said "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."

Dicerna's DCR-HBVS employs RNAi to selectively knock down specific genes involved in the creation of HBV messenger RNA and the entry of the virus into liver cells. According to Dicerna, this approach has shown greater than 99.9% reduction in circulating HBV surface antigen in mouse models of HBV infection, suggesting that DCR-HBVS may "contribute meaningfully" to a functional cure for the disease. Dicerna is currently conducting a Phase I trial of the therapy in healthy volunteers and in patients with non-cirrhotic chronic HBV infection.

Along with the upfront fee, Dicerna is eligible to receive payments of up to $1.47 billion related to development, regulatory and commercial milestones, as well as royalties based on potential sales of DCR-HBVS. The drugmakers noted that Dicerna will retain an option to co-fund pivotal development of DCR-HBVS, which if exercised, entitles it to receive enhanced royalties and co-promote products in the US.

The companies will also use Dicerna's RNAi technology platform GalXC, along with technology from Roche, for the development of additional therapies targeting multiple human and viral genes implicated in chronic HBV infection. As part of the agreement, Dicerna is eligible to receive additional milestones and royalties on any further products.

Last year, Eli Lilly paid Dicerna $100 million upfront, as well as making a $100-million equity investment in the company, as part of a deal to use the GalXC technology platform for targets in the areas of cardio-metabolic disease, neurodegeneration and pain. Meanwhile, Dicerna has also signed pacts with Alexion Pharmaceuticals and Boehringer Ingelheim focused on developing RNAi therapies.

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