Nabriva Therapeutics has acquired Zavante Therapeutics in a stock deal that brings to the antibiotics developer an FDA-ready drug.
Under the deal terms announced after the market close Tuesday, San Diego-based Zavante received an upfront payment of 8.2 million Nabriva (NASDAQ: NBRV) shares. Nabriva, which splits its operations between Ireland and King of Prussia, PA, finished the trading day at $3.30 per share, making that payment worth $27 million. If Zavante’s drug hits regulatory and commercial milestones, that company’s former shareholders stand to gain up to $97.5 million more.
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 deal also brings to Nabriva a management change. When the deal closed, Zavante CEO Ted Schroeder was appointed Nabriva’s new chief executive. He will take a seat on Nabriva’s board of directors following the company’s Aug. 1 shareholders meeting. Former Nabriva CEO Colin Broom will remain on the board and will continue working with the company as a consultant.
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.
Here’s more on Zavante and its antibiotic drugs.
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