Gilead Sciences is acquiring MYR, a German biotech company focused on the development and commercialisation of therapeutics for the treatment of chronic hepatitis delta virus (HDV), for €1.15 billion.
The acquisition will provide Gilead with Hepcludex (bulevirtide), which was conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020.
MYR has since launched Hepcludex in France, Germany and Austria, and continues to prepare for launch in certain other markets throughout 2021. It is expected that this transaction will accelerate the global launch of Hepcludex.
Hepcludex is a first-in-class treatment for HDV that blocks viral entry into liver cells through binding to NTCP.
It is the first and currently the only medicine conditionally approved for HDV by the EMA, and MYR anticipates submission for accelerated approval in the United States in the second half of 2021.
The FDA has granted the medicine both Orphan Drug and Breakthrough Therapy designations for chronic HDV infection.
“HDV is a devastating disease with high unmet medical need. With Hepcludex we have the opportunity to address that need with a first-in-class therapy,” said Daniel O’Day, Chairman and CEO of Gilead Sciences.