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30 Jul 2018

Nabriva acurie Zavante to stregthen antibiotic pipeline

Nabriva Therapeutics has acquired Zavante Therapeutics. Under the deal terms announced after the market close Tuesday, San Diego-based Zavante received an upfront payment of 8.2 million Nabriva.

Zavante’s lead drug candidate, an injectable form of fosfomycin (Contepo), has completed Phase 2/3 studies as a treatment for complicated urinary tract infections. Nabriva’s own drug pipeline has produced lefamulin, an antibiotic that has completed two Phase 3 studies testing it as a treatment for community acquired bacterial pneumonia. Nabriva says it expects to file for FDA approval of both drugs in the fourth quarter of this year.

The Zavante antibiotic isn’t a new drug, rather, it’s a new version of a now generic antibiotic that has been in use in Europe for decades. Though the drug is available in both oral and intravenous forms in Europe and other regions, no FDA-approved IV version is available in the U.S. Zavante developed an IV version of the drug, which it said could be more effective at fighting infections than oral versions.

Because fosfomycin is an older generic drug, Zavante had planned to take the drug through a regulatory pathway that allows a company to use safety data from earlier clinical trials, potentially saving time and money.

The new drug application only needs to show that the new IV formulation is equivalent to the older versions. Nabriva plans to apply for FDA approval of fosfomycin through the same regulatory pathway.

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