- Roche is partnering with Dicerna Pharmaceuticals to develop therapies aimed at curing chronic hepatitis B, announcing Thursday an R&D deal to advance the biotech's experimental RNA interference drug.
- The Swiss pharma will pay Dicerna $200 million, with promises for up to $1.47 billion more in milestone payments tied to development of the RNAi therapeutic, called DCR-HBVS and now in Phase 1 testing. Deal terms also give Roche an option to pursue as many as five additional targets for hepatitis B via Dicerna's platform.
- The collaboration with Roche is Dicerna's fourth with a major drugmaker, following deals with Eli Lilly, Alexion and Boehringer Ingelheim.
Roughly 250 million people have chronic hepatitis B across the world, making it more common globally than the related viral infection hepatitis C.
Unlike hepatitis C, there is a preventive hepatitis B vaccine. For those infected, however, current therapies can provide long-term viral suppression but rarely lead to functional cures, according to Dicerna.
The biotech's research relies on RNA interference — Nobel Prize-winning science that also underpins the drug pipelines of companies like Alnylam Pharmaceuticals.
RNAi medicines work by degrading messenger RNA, the code that transmits genetic instructions to cellular machinery capable for producing proteins. Using RNAi, Dicerna and Roche aim to "selectively knock down specific genes involved in the creation of HBV messenger RNA and the entry of the virus into liver cells," the biotech said in a Thursday statement.
Since becoming a public company in 2014, Dicerna has begun to establish itself, linking up with several blue-chip drugmakers. A deal with Boehringer Ingelheim was signed about two years ago, and Dicerna followed that up with collaborations reached last October with Alexion and Eli Lilly.
Over that time, Dicerna's pipeline has also come into focus, as its lead asset for a rare genetic disorder called primary hyperoxaluria entered pivotal testing. The Cambridge, Massachusetts-based biotech has also advanced into the clinic the hepatitis B treatment which Roche is now partnered on, and DCR-A1AT, a therapy for alpha-1 anti-trypsin deficiency liver disease.
In targeting RNA, Dicerna follows the lead set by Alnylam and Ionis Pharmaceuticals, which pioneered antisense drug development. Alnylam won approval for the first RNAi therapy last year.
Dicerna isn't alone in going after chronic hepatitis B, with several other RNA-targeting drugs in development.
In August, GlaxoSmithKline decided to advance with hepatitis B medicines licensed from Ionis after completing Phase 2 testing, while Johnson and Johnson presented early-stage data on a drug licensed from Arrowhead Pharmaceuticals.
Alnylam and Vir Biotechnology also have a hepatitis B drug called VIR-2218 now in Phase 1/2 testing.
The Roche deal will provide some flexibility for Dicerna, allowing the biotech to eventually choose whether to co-fund the pivotal program and thereby participate in marketing products containing DCR-HBVS, if approved. Exercising its option would also boost Dicerna's royalties on U.S. sales of any commercial drug, according to a regulatory filing by the company.