Gilead Snaps up Germany’s Myr GmbH and Its HDV Drug Hepcludex
Gilead Sciences bolstered its capabilities in treating Hepatitis and other liver diseases with the €1.15 billion ($1.4 billion) cash acquisition of Germany-based Myr GmbH, a company focused on developing therapies for the treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis.
The acquisition brings Myr’s chronic HDV treatment Hepcludex (bulevirtide) under its umbrella. Hepcludex was conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July. Hepcludex is an entry inhibitor that binds to NTCP, an essential HBV and HDV receptor on hepatocytes. It blocks the ability of HDV to enter hepatocytes. Hepcludex is currently the only such medicine approved by the EMA for HDV, the most severe form of viral hepatitis. HDV occurs as a co-infection in individuals who have hepatitis B virus and can have mortality rates as high as 50% within five years in cirrhotic patients.
Gilead Sciences has a solid presence in HBV with multiple marketed drugs, including Viread (tenofovir disoproxil fumarate, TDF) and Vemlidy (tenofovir alafenamide, TAF).
The drug has been launched in several European countries already and Myr has been in the process of commercializing the product in other markets as well. Gilead anticipates the acquisition of Myr will accelerate a global launch for Hepcludex, a first-in-class treatment for HDV that blocks viral entry into liver cells through binding to NTCP. Myr had been planning to file for accelerated approval of Hepcludex with the U.S. Food and Drug Administration in 2021. Hepcludex has already been granted both Orphan Drug and Breakthrough Therapy designations for chronic HDV infection by the FDA.
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“HDV is a devastating disease with a high unmet medical need. With Hepcludex we have the opportunity to address that need with a first-in-class therapy,” Daniel O’Day, chief executive officer of Gilead Sciences said in a statement. “We look forward to working with the team at MYR to realize the full potential of Hepcludex for patients with HDV worldwide. This will build on the work that Gilead has been doing for almost two decades to innovate and improve therapies for viral hepatitis.”
It is estimated that at least 12 million people are currently co-infected with both hepatitis B and HDV. A co-infection worsens liver disease and is associated with a faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death. In the United States and Europe, there are collectively more than 230,000 people living with HDV, Gilead said.
Dmitry Popov, CEO of Myr GmbH, said he is excited about the company’s merger with Gilead. He said the California-based company’s experience in liver disease will help Myr realize the full potential of Hepcludex and provide drug access to as many patients around the world as possible.
Under terms of the deal, Gilead Sciences plunked down €1.15 billion in cash and could pay out an additional to €300 million upon FDA approval of Hepcludex.