Hoping to Boost Revenue Growth, Gilead Acquires MYR in a $1.4 B Deal
Gilead sciences expects to expand its hepatitis pipeline by acquiring MYR GmbH in an all-cash deal worth $1.4 B (1.15 B euros), payable upon closing of the transaction. MYR, German biotech based in Bad Homburg, is developing hepcludex (bulevirtide)—a first-in-class medicine—to treat chronic hepatitis delta virus (HDV) infection. Under the terms of the sale and purchase agreement, Gilead will pay an additional milestone payment of up to $362 M, reported as 300 M euros, upon FDA approval.
In July of this year, MYR received conditional approval to market hepcludex from the European Medicines Agency (EMA), making it the first and only approved medicine for HDV. MYR is currently selling the drug in France, Germany, and Austria and plans to launch in more countries next year. The company intends to seek accelerated approval from the FDA in the second half of 2021. The FDA has already granted both Orphan Drug and Breakthrough Therapy designations for use in chronic HDV cases.
Hep D is a severe form of viral hepatitis with extremely high death rates in cirrhotic patients; however, the infection can be transmitted only to patients who are already infected with hepatitis B. Around 12 million people worldwide are reported to have the disease, with about 230,000 in the US and Europe, while the condition largely remains underdiagnosed.
“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,” said Daniel O’Day, Chairman, and Chief Executive Officer, Gilead Sciences. “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.”
“We are proud of our achievement in bringing Hepcludex from preclinical stage to patients in need within such a short timeframe,” said Dmitry Popov, Chief Executive Officer, MYR GmbH. “We are excited to join Gilead, whose experience in the hepatitis field and global infrastructure will realize the full potential of Hepcludex and provide access to as many patients as possible around the world with this debilitating disease.”
Hepcludex is a first-in-class treatment for HDV that blocks viral entry into liver cells through binding to NTCP, an essential HBV and HDV receptor on liver cells. HDV co-infection is much worse than HBV alone in causing severe liver disease and cirrhosis and increases the risk of liver cancer and death. The drug has been tested in more than 500 patients in completed and ongoing clinical studies. The benefit of hepcludex includes an effective reduction of viral RNA and improvement of liver inflammation.
By Sangeeta Chakraborty, Ph.D.
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