Gilead Sciences, Inc. and MYR GmbH, a German biotechnology company focused on therapeutics for chronic hepatitis delta virus (HDV), have entered a definitive agreement under which Gilead will acquire MYR for approximately €1.15 billion in cash, plus a potential future milestone payment of up to €300 million.

Gilead will gain 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 in 2021.

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 U.S. 2H21. The FDA has granted Hepcludex both Orphan Drug and Breakthrough Therapy designations for chronic HDV infection.

HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within 5 years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). At least 12 million people worldwide are likely currently co-infected with HDV and HBV.

The transaction is subject to customary closing conditions.