XERAVA

XERAVA® (eravacycline) for injection is a novel fluorocycline of the tetracycline class. XERAVA® is an antibiotic used to treat complicated intra-abdominal infections (cIAI) in adults. "Complicated" means that the infection is difficult to treat because it has spread to the abdomen.

The mechanism of action of eravacycline is to interfere with bacterial protein synthesis by binding to the ribosomal subunit 30S, thereby preventing the incorporation of amino acid residues into extended peptide chains.

XERAVA® has been shown to be as effective as alternative antibiotics in two main trials in adults with cIAI. The main indicator of efficacy in both trials was the cure rate of infections. In the first trial, involving 538 patients, XERAVA® was compared with ertapenem (another antibiotic). After about one month, 87% of patients treated with XERAVA® were cured of their infection, compared with 89% of patients treated with ertapenem. In the second trial, involving 499 patients, XERAVA® was compared with meropenem (another antibiotic). After about one month, 92% of patients treated with XERAVA® and 92% of patients treated with meropenem were cured of their infection.

XERAVA® is FDA-approved for the treatment of complicated abdominal infections in patients 18 years of age and older. XERAVA® is approved by the European Commission and the UK Medicines Agency for the treatment of abdominal infections in adults. Prescribing information for XERAVA® is available at www.xerava.com.

PAION currently plans the European commercial launch of XERAVA® in the second half of 2021. In Europe, PAION currently estimates a peak sales potential of approximately EUR 25 million to approximately EUR 35 million annually based on its own projections.