BAD HOMBURG, Germany, Sept. 17, 2020 /PRNewswire/ -- MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that HEPCLUDEX® (bulevirtide) has successfully launched in Germany, France and Austria.
On July 31st HEPCLUDEX® was granted Conditional Marketing Authorization (CMA) by the European Commission as the first approved treatment in Europe for adult patients with chronic hepatitis delta virus (HDV) infection and compensated liver disease.
"We are excited to launch HEPCLUDEX® in Germany, France and Austria," said Florian Vogel, Chief Commercial Officer at MYR Pharmaceuticals. "We look forward to working with our partners to provide HEPCLUDEX® to patients suffering from chronic Hepatitis D. The commercial launch represents a key milestone for MYR Pharmaceuticals and we are thankful for the support we have received from the medical and scientific community, as well as patient organizations. We also look forward to further expanding access to HEPCLUDEX® in additional markets in the future."
About HEPCLUDEX® (INN = bulevirtide)
HEPCLUDEX® is the first approved drug for the treatment of chronic hepatitis D in Europe. HEPCLUDEX® blocks the NTCP receptor on the surface of hepatocytes and prevents the entry of HBV/HDV into hepatocytes and viral spread within the liver. HEPCLUDEX® has received Orphan Drug Designation for treatment of HDV infection from EMA and from the U.S. Food & Drug Administration (FDA). HEPXLUDEX® has been granted PRIority MEdicines (PRIME) scheme eligibility by EMA and Breakthrough Therapy Designation by FDA.
About Hepatitis Delta
Chronic Hepatitis Delta is the most severe form of viral hepatitis in humans and is caused by infection with the Hepatitis Delta Virus (HDV). Hepatitis D only occurs as a co-infection in individuals infected with Hepatitis B Virus (HBV). HDV co-infection leads to more serious liver disease than HBV infection alone and is associated with a faster progression to liver fibrosis, cirrhosis, decompensated cirrhosis and an increased risk of liver cancer and liver failure.
About MYR Pharmaceuticals
MYR Pharmaceuticals is headquartered in Bad Homburg (Germany). The company started operations in 2011 and is supported by venture capital investors such as the High-Tech-Gründerfonds (www.htgf.de/en/) and Maxwell Biotech Venture Fund. More information is available at www.myr-pharma.com.
Thomas Christély, CFO
Phone: +49 (0)6172-4959811