One of Britain’s largest drug companies secured a fast track review of a potentially blockbuster treatment of chronic hepatitis B.
GSK announced that the US Food and Drug Administration has granted bepirovirsen an expedited approval process because it could address a medical need unmet for a life-threatening condition.
Globally, the long-lasting infection is caused by the inability of the immune system to combat the virus. It then remains in the blood or liver. Hepatitis B, even with treatment, can cause liver complications such as cancer or cirrhosis.
GSK expects annual sales peak of at least £2 Billion. The drug is currently in the late stages of development and will be available in 2027.
In 2019, it was licensed by Ionis Pharmaceuticals (an American company) and, last year, GSK agreed with Johnson & Johnson to pay up $1 billion to gain exclusive rights for the further development and commercialisation of a hepatitis-B therapy that the American drug group owned. This will help expand the use of bepirovirsen.
Melanie Paff said, “Being able to show data this promising, the buzz around the data was just a little overwhelming.” Melanie Paff is the lead scientist at GSK for the drug.
GSK stated that bepirovirsen was “the only single agent in Phase-III development which has demonstrated the potential to achieve a clinically meaningful functional curing response” when combined together with currently available oral antiviral treatments. The latter suppresses only the virus.
GSK is a FTSE 100 based company in London, led by Dame Emma Walmsley. She has been working to improve the productivity of her drugs pipeline, and its share price for many years. The company has tried to speed up the process by buying promising assets from biopharmaceuticals firms.
It said that it had upgraded its long-term financial projections, and expected at least twelve major new product launches by 2025 which would generate sales of at least £2 billion.
GSK shares closed at £16.261/2, down by 33 1/2p or 2 percent, despite the FDA’s designation of the drug as fast-track. The shares are up around 10% over the last 12 months.