Arrowhead Research reported on Aug. 12 that patients in its Phase II clinical trial of the ARC-520 RNA interference candidate for hepatitis B had a "similar" knockdown to those reported in primate studies. The stock price fell at the very end of the trading day to close at $12.00 from an opening-day price of $13.00.
The drug is approved for treating--not preventing--hepatitis B, prompting FDA to call the advert misleading.
To help design next-generation drugs for hepatitis B and C, researchers have developed a humanized mouse model that contains human liver cells and mimics the immune system of people.
RNAi specialist Alnylam is adding a hepatitis B virus therapy to its pipeline of candidates that employ its Enhanced Stabilization Chemistry-GalNAc-conjugate technology enabling subcutaneous dosing and plans to file an IND by the end of 2015.
FDA and EMA requests for more data on hepatitis B candidate Heplisav have set Dynavax Technologies back time and again. Now, Dynavax is embarking on a new trial it hopes will address some of those safety concerns.
Arrowhead, fresh off a $120 million public offering in February, is paving the way on what it has called a "functional cure" for hepatitis B, beginning dosing in a Phase IIa trial for its RNAi drug designed to deliver the genetic material to the nucleus using a polymer-based conjugate.
Last week research firm GlobalData tipped the hepatitis B vaccine market to top $1 billion by 2022, with sales of Sanofi's Hexyon driving the sector's modest growth. Dynavax hopes to claim a slice of the market too, but its hepatitis B vaccine received another blow this week.
The National Adult Vaccination Program and others have proposed strategies to raise the proportion of adults getting vaccinated against pneumococcal disease, shingles and hepatitis B, but the latest data shows little change in immunization rates.
The start of 2014 has been a tumultuous period for Chinese manufacturers of hepatitis B vaccines, with three leading producers failing to gain quality certificates and authorities investigating 17 baby deaths. This week, China reassured its population there is no link between the vaccine and the deaths, but a history of cover-ups mean people are still suspicious.
China's push to raise manufacturing standards was always likely to result in a few hiccups as companies raced to bring production plants into line with new regulations. And with the deadline for producers of injectables now having passed, it appears the hepatitis B vaccine market faces a tricky few months.