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Hepcludex® (formerly Myrcludex B)

Products Next higher product group bulevirtide (INN)
Period Status 2020-08-04 registration start
Organisations Organisation MYR GmbH (MYR Pharmaceuticals)
  Group Gilead Sciences (Group)
  Organisation 2 Inserm Transfert S.A.
  Group France (govt)
  Original research University of Heidelberg (Ruperto Carola)

MYR GmbH. (6/10/20). "Press Release: MYR Pharmaceuticals Has Incorporated Its First European Subsidiary in France". Bad Homburg.

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 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.

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 and Maxwell Biotech Venture Fund. More information available at

Contact Details

Thomas Christély, CFO
Phone: +49 (0)6172-4959811

Record changed: 2020-12-13


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