MYR Pharmaceuticals is pleased to announce the establishment of its wholly owned subsidiary MYR Pharmaceuticals France SAS, located in Paris (France).
Today, around 15-20 million people worldwide are chronically infected with the hepatitis D virus for whom no approved therapies are available. The company's lead compound Hepcludex® (international nonproprietary name/INN = bulevirtide, formally known as Myrcludex B) is a first-in-class entry inhibitor for the treatment of chronic HBV and HDV infection. The technology was originally developed at the University of Heidelberg (Germany) and INSERM (France). For MYR Pharmaceuticals, the creation of its first European subsidiary represents its commitment to help the French patients suffering from HBV/HDV coinfection.
"We are very pleased to announce the foundation of our French subsidiary. The subsidiary builds the backbone for providing the innovative therapy to patients in need. We are thankful for the support from authorities, regulatory bodies, physicians, patient organizations and all members of the professional medical community in France and look forward to continuing our collaboration," commented Florian Vogel, Chief Commercial Officer at MYR Pharmaceuticals.
About Hepcludex® (INN = bulevirtide)
Hepcludex® represents the most clinically advanced novel approach for the treatment of hepatitis B and D, and is currently in a Phase 3 study in the indication of chronic HDV. The drug inhibits the NTCP receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spreading within the liver. Hepcludex® has received Orphan Drug Designation for treatment of HDV infection from the European Medicines Agency (EMA) and from the U.S. Food & Drug Administration (FDA). In addition, the EMA has granted PRIority MEdicines (PRIME) scheme eligibility.
The positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of EMA regarding the Conditional Marketing Authorization (CMA) was published May 29th 2020.