MYR Pharmaceuticals在德国，法国和奥地利推出HEPCLUDEX®

StephenW

MYR Pharmaceuticals launches HEPCLUDEX® in Germany, France and Austria

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.

Contact Details Thomas Christély, CFO Phone: +49 (0)6172-4959811 Email: [email protected]

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SOURCE MYR Pharmaceuticals

StephenW

MYR Pharmaceuticals在德国，法国和奥地利推出HEPCLUDEX®

德国巴德洪堡，2020年9月17日/美通社/-MYR Pharmaceuticals是一家专注于慢性乙型和丁型肝炎治疗药物的开发和商业化的德国生物技术公司，欣然宣布HEPCLUDEX®（bulevirtide）已在德国，法国和奥地利成功推出。

7月31日，HEPCLUDEX®被欧洲委员会授予有条件销售许可（CMA），这是欧洲第一个批准的用于慢性肝炎三角洲病毒（HDV）感染和代偿性肝病成年患者的治疗药物。

MYR Pharmaceuticals首席商务官Florian Vogel说：“我们很高兴在德国，法国和奥地利推出HEPCLUDEX®。 “我们期待与合作伙伴合作，为患有慢性D型肝炎的患者提供HEPCLUDEX®。该产品的上市是MYR Pharmaceuticals的一个重要里程碑，我们也感谢医学界和科学界的支持作为患者组织。我们也希望将来在其他市场进一步扩大对HEPCLUDEX®的访问。”

关于HEPCLUDEX®（INN = bulevirtide）HEPCLUDEX®是欧洲首个获批的用于治疗慢性D型肝炎的药物。 HEPCLUDEX®阻断肝细胞表面的NTCP受体，并阻止HBV / HDV进入肝细胞和病毒在肝脏内扩散。 HEPCLUDEX®已从EMA和美国食品药物管理局（FDA）获得了用于治疗HDV感染的孤儿药称号。 HEPXLUDEX®已获得EMA的优先医学（PRIME）计划资格，并获得FDA的突破性治疗指定。

关于肝炎三角洲慢性肝炎三角洲是人类中最严重的病毒性肝炎，是由感染肝炎三角洲病毒（HDV）引起的。 D型肝炎仅在乙型肝炎病毒（HBV）感染的个体中作为共同感染发生。 HDV合并感染比单独的HBV感染导致更严重的肝脏疾病，并且与更快地发展为肝纤维化，肝硬化，代偿性肝硬化以及肝癌和肝衰竭的风险增加有关。

关于MYR制药MYR制药总部位于德国巴特洪堡。该公司于2011年开始运营，并得到了诸如High-Tech-Gründerfonds（www.htgf.de/en/）和Maxwell Biotech Venture Fund等风险资本投资者的支持。有关更多信息，请访问www.myr-pharma.com。

联系方式首席财务官ThomasChristély电话：+49（0）6172-4959811电子邮件：[email protected]

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消息来源MYR Pharmaceuticals