Omadacycline is a once-daily oral and intravenous (IV) broad-spectrum antibiotic in a new class of tetracycline derivatives, known as aminomethylcyclines. In 2017, we obtained an exclusive license to develop, manufacture and commercialize Omadacycline in mainland China, Hong Kong (China), Macau (China) and Taiwan region from Paratek Pharmaceuticals, Inc. Omadacycline has been designed to address tetracycline resistance, and is being developed for acute bacterial skin/skin structure infections (ABSSSIs), community-acquired bacterial pneumonia (CABP) and urinary tract infections (UTIs). Three pivotal Phase III studies of Omadacycline in ABSSSI and CABP have achieved their respective primary endpoints. Omadacycline has been granted Qualified Infectious Disease Product (QIDP) status in the United States and Fast Track status by the FDA. On October 2, 2018, Omadacycline was approved for the treatment of adults with CABP and ABSSSI by FDA. In China, Zai lab received the approval from Chinese CDE (Center for Drug Evaluation) in July 2018 and is currently preparing the local clinical study.
Mechanism of Action
Antibiotic resistance has become a significant public health challenge and there is an increasing need for effective, well-tolerated antibiotics. Omadacycline has been designed to overcome the two major mechanisms of tetracycline resistance, known as pump efflux and ribosome protection. Omadacycline has an effective microbiological activity against a broad spectrum of pathogens, including problem pathogens like methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae, gram-negative pathogens such as H. influenzae and atypical bacteria such as Legionella. It has strong activity against most of the pathogens encountered in the indications pursued.