Gilead Sciences and MYR GmbH, announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MYR for approximately €1.15 billion in cash, payable upon closing of the transaction plus a potential future milestone payment of up to €300 million (both payments subject to customary adjustments).
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 US Food and Drug Administration (FDA) has granted the medicine 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 per cent within five 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. HDV co-infection leads to more serious liver disease than HBV alone 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, which remains underdiagnosed globally.
Hepcludex (bulevirtide) is an entry inhibitor that binds to NTCP, an essential HBV and HDV receptor on hepatocytes, blocking the ability of HDV to enter hepatocytes. Bulevirtide has been tested in more than 500 patients in completed and ongoing clinical studies. The benefit of bulevirtide has been demonstrated by an effective reduction of HDV RNA levels and improvement of liver inflammation. In the MYR202 study, which was a controlled, open-label Phase 2 study, 54 of 90 patients treated with bulevirtide plus tenofovir disoproxil fumarate (TDF) had at least a 2 log10 HDV RNA decline or undetectable HDV RNA at week 24 versus 1 of 28 patients given TDF alone. Almost half of patients treated with bulevirtide and TDF also showed a normalisation in the blood levels of the liver enzyme ALT, indicating an improvement of liver disease, as compared to seven per cent of patients who received TDF alone.
In Phase 2 MYR203 study evaluating a 48-week treatment course of bulevirtide, a further 15 patients were treated with Hepcludex 2 mg daily monotherapy for 48 weeks. In this limited dataset, the safety and efficacy profiles were similar to patients treated for 24 weeks in combination with TDF in the MYR202 study. Interim 24-week data from the ongoing Phase 3 study MYR301 of bulevirtide is anticipated in the first half of 2021 and is expected to serve as the basis for filing in the US.