GSK takes option to license hepatitis B RNA drugs from Ionis


GlaxoSmithKline has taken an option to license Ionis’ antisense medicines for people with chronic hepatitis B virus infection after supportive phase 2 trial results.

Ionis could receive up to $262 million, including a $25 million up front license fee, and tiered royalties in the low double digits on net sales.

The two drugs, IONIS-HBVRX and IONIS-HBV-LRX, are part of a large portfolio of RNA-targeting drugs that Ionis is developing for big pharma clients.

Other partnerships include Roche, Biogen, Bayer, and AstraZeneca, who like GSK are looking for pipeline drugs that have a good chance of making it through development and have significant sales potential if approved.

GSK is not responsible for all development, regulatory and marketing activities and costs, assuming the deal is not challenged by US competition regulators.

Under research chief Hal Barron, GSK is attempting to spice up its pipeline and is on the hunt for drugs with blockbuster-level potential.

Barron is prepared to take some risks to achieve this goal after saying that the “play it safe” R&D culture that took hold at GSK under the previous management had failed to produce results.

GSK’s revenues are still being propped up by its ageing respiratory blockbuster Advair, which finally faces generic competition in the US after potential challengers struggled to get approved by the FDA.

CHB is a chronic viral infection of the liver that can lead to significant and potentially fatal health conditions, including cirrhosis, liver failure and liver cancer.

Current treatments for patients with CHB provide low levels of hepatitis B virus S antigen seroclearance, leaving many patients without a treatment to achieve sustained disease remission. There are more than 200 million patients worldwide living with CHB.

“By targeting the root cause of CHB-related liver disease, our antisense technology can potentially deliver a transformative medicine for people who suffer from chronic hepatitis B virus infection,” said Brett P. Monia, chief operating officer at Ionis.

“We believe GSK's development and commercialisation expertise in infectious diseases makes them the ideal partner to help address this high unmet need.”