The Menarini Group Announces Meropenem/vaborbactam European Marketing Authorization

FLORENCE,Italy,December 12,2018 --

Meropenem/vaborbactam approved on 20th November 2018 by the European Commission for clinical use in adult patients with difficult-to-treat infections

The first combination of a carbapenem and a beta-lactamase inhibitor approved for clinical use in Europe

The Menarini Group has recently reached an agreement with Melinta Therapeutics to commercialize meropenem/vaborbactam in Europe,Asia-Pacific and CIS.

As highlighted by the Group's General Manager,Pio Mei,"The meropenem/vaborbactam European approval is the first great achievement coming from our partnership with Melinta. It confirms Menarini's commitment in the Infectious Disease Area and its involvement in the fight against the antimicrobial resistance threat,a highly unmet need."

Meropenem/vaborbactam was initially approved by the FDA for complicated urinary tract infections,including pyelonephritis,in adult patients on the basis of the pivotal TANGO I trial.

The European approval relied also on the results of the TANGO II trial,the largest trial conducted so far in patients with Carbapenem-Resistant Enterobacteriaceae (CRE) infections. According to the trial's results,the range of clinical indications for meropenem/vaborbactam has been expanded by adding to cUTI (including pyelonephritis) also hospital-acquired/ventilator-associated bacterial pneumonia,complicated intra-abdominal infections and bacteremia associated with these previous infections.

Vaborbactam is a potent first-in-class inhibitor of class A (including the KPC,Klebsiella pneumoniae carbapenemase) and class C beta-lactamases,and it protects meropenem from degradation by serine carbapenemases,restoring its activity against carbapenem-resistant strains.

In TANGO II,meropenem/vaborbactam as intravenous monotherapy,compared with the "best available treatment," was associated with increased clinical cure,reduced mortality,and lower treatment-related AEs (e.g. nephrotoxicity). The increased cure rate was statistically significant also in immunocompromised patients,a group usually excluded from clinical trials.

The spread of carbapenem resistance in Gram negative bacteria represents a serious and growing threat worldwide as identified by the WHO and CDC. CRE infections,because of limited therapeutic options,are associated with high rates of mortality as well as increased length of hospital stay and costs. According to the most recent data from the European Antimicrobial Resistance Surveillance Network (EARS-Net),the prevalence of invasive CRE isolates reaches worrisome levels particularly in some European countries. Romania,Italy and Greece show a rate of 31%,34% and 67%,respectively,for invasive Klebsiella pneumoniae isolates (from blood and cerebrospinal fluid) with resistance to carbapenems.

In this context,meropenem/vaborbactam appears to be a potential game changer in the fight against difficult-to-treat Gram negative infections,satisfying an important medical issue linked to antibiotic-resistant Enterobacteriaceae.

About the Menarini Group

The Menarini Group is an Italian pharmaceutical company with a turnover of 3.6 billion Euro and more than 17,000 employees. With 16 manufacturing sites and 7 R&D centers,Menarini has a capillary presence in 136 countries.

http://www.menarini.com