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Nabriva Therapeutics Resubmits New Drug Application for Intravenous CONTEPO(TM) (fosfomycin) for Injection
2019-12-20 06:00:10 AM ET (GlobeNewswire)
   
-Nabriva anticipates a six-month review period by the Food and Drug Administration

-CONTEPO is a potential first-in-class intravenous antibiotic in U.S. for the treatment of complicated urinary tract infections

Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CONTEPO(TM) (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva anticipates a six-month review period by the FDA.

The NDA for CONTEPO was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in April 2019. The CRL stated that the FDA was unable to approve the NDA in its present form based on issues related to facility inspections and manufacturing deficiencies at one of the Company's contract manufacturers. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO.

"We are pleased to have received input from the FDA on the required information to include in the CONTEPO NDA resubmission to address the CRL," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. "With the rising prevalence of extended spectrum beta-lactamases (ESBL) and carbapenem resistance (CRE), CONTEPO has the potential to be an important new treatment option for patients with cUTI caused by Gram-negative pathogens. We look forward to continuing to work with the FDA to bring this important treatment option to patients in the United States."

In its 2019 report on Antibiotic Resistance Threats in the United States, the Centers for Disease Control and Prevention (CDC) designated CRE and ESBL resistance as urgent and serious threats in the United States. According to the CDC, both CRE and ESBL resistance are major concerns for patients in healthcare facilities, with some Enterobacteriaceae resistant to nearly all antibiotics, leaving more toxic or less effective treatment options.

About CONTEPO

CONTEPO (fosfomycin) for injection is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as extended spectrum B-lactamase (ESBL)-producing Enterobacteriaceae. ESBL enzymes break down and destroy some commonly used antibiotics such as Carbapenem therapy, leading to an increase in Carbapenem resistance.

CONTEPO has a differentiated mechanism of action that results in broad spectrum microbiologic activity against MDR pathogens with limited available treatment options; no observed cross-resistance with other antibiotic classes; and demonstrated in vitro synergy or additive effect in combination with other antimicrobial classes. CONTEPO utilizes a new dosing approach, originally developed by Zavante Therapeutics (which Nabriva Therapeutics acquired in 2018), to optimize its pharmacokinetics and pharmacodynamics. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.

Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as an early appropriate treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. An estimated 40 percent of cUTIs are suspected to be caused by MDR bacteria and limited treatment options are available in the U.S. for these patients.