SAN JOSE, CA., Sept 3, 2020 /CPCNewswire/ — CPC Scientific Inc. is pleased to announce that the European Commission (EC) has granted the Conditional Marketing Authorization (CMA) for MYR Pharmaceuticals lead compound HEPCLUDEX®. CPC Scientific serves as a supplier and partner to MYR Pharmaceuticals for the development and manufacturing of bulevirtide (Hepcludex). This drug is intended for the treatment of chronic hepatitis delta virus (HDV) infection in adult patients with compensated liver disease, and effectively reduces HDV RNA levels and signs of liver inflammation in treated patients.
Hepcludex is classified as an orphan medicine, a designation reserved for APIs developed for use against rare, life-threatening, or chronically debilitating conditions or which, for economic reasons, would be unlikely to have been developed without aid. Approximately 4 in 10,000 people in the European Union (EU) are affected by the hepatitis delta virus infection (totaling around 205,000 individuals): a segment small enough to be overlooked by the research community at large. It is CPC Scientific’s honor to work towards the alleviation of human suffering on any scale, and an additional privilege to work with like-minded partners like MYR Pharmaceuticals.
About CPC Scientific Inc.
Founded in 2001, CPC Scientific is a globally recognized and leading CDMO specializing in synthetic peptide production. The company works directly with leaders in the biotechnology and pharmaceutical industries to help bring life-changing therapeutics and diagnostics to market. They boast the largest research peptide facility in the world, which successfully has undergone multiple FDA inspections and audits by global pharma organizations. CPC Scientific has the capability of serving customers from early drug discovery stages through clinical trials to commercial manufacturing. We provide milligram to multi-kilogram quantities of CGMP and research-grade peptides with purities of up to 99%. With their emphasis on technology, innovation, and experience, we are proud to have a US FDA inspected GMP facility, ISO 9001, and ISO 13485 certification, a claim few companies in the world can make.
Inquiries:
CPC Scientific Inc.
+1-408-734-3800
EMAIL: marketing@cpcscientifc.com
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/
About HEPCLUDEX® (INN = bulevirtide)
HEPCLUDEX® represents the most clinically advanced novel approach for the treatment of hepatitis D, and is currently in a Phase 3 study in the indication of chronic HDV. The drug inhibits the HBV/HDV receptor NTCP on the hepatocyte surface and prevents the infection of regenerating 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. In parallel the FDA has granted Breakthrough Therapy designation – a process designed to expedite the development and review of drugs which may demonstrate substantial improvements on a clinically significant endpoint. The development of HEPCLUDEX® has been supported by a grant from the German Center for Infection Research (DZIF; www.dzif.de/en), a foundation which was initiated by the German Federal Ministry of Education and Research (BMBF).
