European Commission (EC) Grants Conditional Marketing Authorization (CMA) for MYR Pharmaceuticals HEPCLUDEX®
SAN JOSE, Calif. - Sept. 3, 2020 - PRLog -- 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):
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.
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-Grü
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