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Gilead set to acquire hepatitis specialist MYR for €1.15bn

Acquisition will see Gilead pick up HDV treatment Hepcludex

Gilead will pay approximately €1.15bn to acquire MYR GmbH for access to the German biotech’s chronic hepatitis delta virus (HDV) treatment Hepcludex.

Hepcludex (bulevirtide) received a conditional approval from the European Medicines Agency (EMA) for the treatment of chronic HDV in adults with compensated liver disease in July.

HDV is a severe form of viral hepatitis that carries mortality rates as high as 50% within five years in cirrhotic patients.

According to Gilead, at least 12 million people globally are currently co-infected with HDV and hepatitis B virus (HBV).

Patients with HDV co-infection are at a higher risk of developing serious liver disease compared to those living with HBV infection alone. Those with HDV may also experience faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death.

Hepcludex treats HDV by blocking viral entry into liver cells through binding to NTCP, which is an essential HBV and HDV receptor of hepatocytes (liver cells). It is currently the first and only drug with conditional approval in the EU for HDV.

In addition to the EMA conditional approval, MYR expects to submit Hepcludex to the US Food and Drug Administration (FDA) for accelerated approval in the second half of 2021.

Under the terms of the deal, Gilead will pay approximately €1.15bn in cash on closing the transaction, plus a potential future milestone payment of up to €300m dependent on the US approval of Hepcludex.

The novel drug has already been granted orphan drug and breakthrough therapy designations from the FDA for the treatment of chronic HDV.

It has been tested in over 500 patients in both completed and ongoing studies, demonstrating an effective reduction of HDV RNA levels and improvements of liver inflammation.

In the phase 2 MYR202 study, 54 of 90 patients treated with Hepcludex and tenofovir disoproxil fumarate (TDF) had at least a 2 log10 HDV RNA decline or undetectable HDV RNA at week 24 versus one out of 28 patients who only received TNF.

“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 chief executive officer of Gilead.

“We look forward to working with the team at MYR to realise 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,” he added.

Article by
Lucy Parsons

11th December 2020

From: Sales

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