Manufacturing concerns spike Nabriva’s plans to launch its first antibiotic — for now
In another setback for the beleaguered antibiotics field, Nabriva Therapeutics says the FDA rejected its fosfomycin for complicated urinary tract infections.
Importantly, the biotech says, regulators are not asking for any new clinical or safety data. The complete response letter centers around “issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers,” according to a brief statement.
Over the next few weeks Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. Shares $NRBV are down 24% pre-market.
Across the industry, antibiotics developers and backers are suffering from a new low in morale after Achaogen filed for bankruptcy despite notching an FDA approval of its cUTI drug, due to disappointing sales. And that follows rounds of layoffs at both Achaogen and other antibiotics companies like Melinta, with Big Pharma largely out of the picture altogether.
Nobody would deny the urgent need for antibiotics — just two days ago the UN issued another report warning of a “silent tsunami” of antimicrobial resistance that threatens to kill 10 million people annually by 2050 — but it’s increasingly hard to make a case for the R&D investment when the products are too niche to turn a profit in a world dominated by generics.
Nabriva’s Contepo (IV fosfomycin) is an old drug that’s been used outside the US for over 45 years. According to the company, it can treat a number of Gram-negative and Gram-positive bacteria infections, active against many common multi-drug resistant strains.
It bagged the drug via an acquisition of Zavante, whose CEO Ted Schroeder then took the helm of the new entity. Nabriva’s in-house lead program for community-acquired bacterial pneumonia, lefamulin, is also under review with a PDUFA date in August.