HSA’s positive decision marks Everest Medicines’ rst-ever regulatory approval among robust pipeline of therapeutic candidates in development
SHANGHAI, China, April 17, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the Health Science Authority (HSA) has approved Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adults in Singapore.
Xerava is a novel, fully-synthetic, broad-spectrum parenteral uorocycline antibiotic of the tetracycline class. This approval was based on data from global pivotal studies in which eravacycline established an acceptable safety prole in people with cIAI and demonstrated statistical non-inferiority to two widely used comparators – ertapenem and meropenem. Eravacycline is a new option for the management of complicated infections especially those due to drug resistant pathogens.
“Our rst regulatory approval is an important milestone for Everest Medicines and reinforces our commitment to accelerate the development and commercialization of our broad pipeline of novel drug candidates to address the unmet medical needs in Greater China and other parts of Asia,” said Sunny Zhu, Chief Medical Ocer for Infectious Diseases at Everest Medicines. “This approval makes available a new and innovative choice for patients and physicians in the management of serious infectious diseases given the limitations of current therapies driven by the increasing prevalence of drug resistance and MDR Gram-negative infections. We look forward to working closely with the healthcare professionals in Singapore to leverage their experiences as we work to also bring this important therapy to other parts of East Asia and the South East Asia region.”
Under the licensing agreement with Tetraphase Pharmaceuticals, Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, including Indonesia, Malaysia, Philippines, Thailand, Singapore and Vietnam. The Company is in the process of preparing regulatory lings across these additional markets, and is conducting a robust clinical development program in China to support regulatory approval. Xerava is currently approved for the treatment of cIAI in the US and EU.
“HSA’s rapid approval of Xerava is a testament to Everest Medicines’ expertise and our ability to speed the advancement of globally innovative therapeutics into untapped and underserved markets,” said Kerry Blanchard, MD, PhD, Chief Executive Ocer of Everest Medicines. “HSA’s positive decision, combined with Singapore’s reputation for its advanced health system and early adoption of innovative medicines, provides further support for Xerava in our ongoing regulatory discussions in other target markets such as Greater China.”
About Complicated Intra-Abdominal Infections
Complicated intra-abdominal infections (cIAI) are a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from the perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.
About Xerava™ (eravacycline)
Xerava (eravacycline) is a parenteral, potential best-in-class, novel, synthetic tetracycline analog that blocks bacterial protein synthesis by binding to the 30S ribosomal subunit. Xerava (eravacycline) has shown broad in vitro activity against
Enterobacteriaceae and Acinetobacter, Gram-negative pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Everest Medicines initiated a pivotal trial in China for patients with complicated intra-abdominal infections (cIAI) in mid-2019. Xerava (eravacycline) was licensed from Tetraphase Pharmaceuticals.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high- quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. For more information, please visit its website at www.everestmedicines.com.
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