Everest Medicines Announces Approval of Xerava™ from the Health Science Authority in Singapore for the Treatment of Complicated Intra-Abdominal Infections

Apr  2020

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.


For further information, please contact:


Everest  Medicines


Media in US and Europe: Darcie Robinson

Vice President Westwicke PR (203) 919-7905

darcie.robinson@icrinc.com


Media in China: Edmond  Lococo Senior Vice President ICR Asia

+86 (10) 6583-7510  edmond.lococo@icrinc.com


Jianfeng Pei Vice President ICR Asia

+86 139 1182 4874  jianfeng.pei@icrinc.com

info@cbridgecap.com
www.cbridgecap.com
© 2020 CBC Group. All Rights Reserved.