In addition, Lonza, Medivir's partner for process development and manufacture of drug substance, has developed a process suitable for commercial manufacture of fostrox drug substance with plans underway for the final optimization, qualification and validation activities needed to support an accelerated approval after the planned phase 2b study. Lonza will also provide expert regulatory services to Medivir.

Based on promising clinical data for fostrox + Lenvima in the ongoing phase 1b/2a study in second line HCC, together with the lack of approved medical treatments after tumor progression on first line standard of care, the company has communicated the plan to initiate phase 2b study with accelerated approval intent. A GMP campaign of fostrox, produced with an updated process suitable for commercial manufacture, is critical to enable study start of the planned study.

"This is another important step in our efforts to ensure speed and momentum in the fostrox development program. It has the potential to become the first, approved treatment option for patients that have progressed on current first line standard of care and it is imperative that we move ahead with as much speed as possible. We are very pleased with our collaboration with Lonza to ensure continued momentum.", says Jens Lindberg, CEO at Medivir.