Shares of Nabriva Therapeutics are rising this morning after the company announced it acquired privately-held Zavante Therapeutics.
Shares of Nabriva Therapeutics are rising this morning after the company announced it acquired privately-held Zavante Therapeutics in an all-stock deal that will bring the company’s investigational injectable antibiotic Contepo into its pipeline. Nabriva plans to seek regulatory approval of the drug by year’s end.
Contepo (fosfomycin, which has previously been known as ZTI-01 is being developed for the treatment of serious infections, including those caused by multi-drug resistant Gram-negative and Gram-positive bacteria. Outside of the United States, intravenously-delivered fosfomycin has been used broadly to treat a variety of indications, including complicated urinary tract infections (cUTIs) and other serious bacterial infections, Nabriva said this morning. Zavante has developed Contepo with an eye on the treatment becoming a standard-of-care for hospitalized patients with serious infections caused by suspected or confirmed MDR bacteria.
Colin Broom, Nabriva’s former chief executive officer, said his company’s supply chain infrastructure will be able to support Contepo’s launch in the United States, should it achieve regulatory approval. The company will file a New Drug Application with the U.S. Food and Drug Administration (FDA) by the end of 2018, Broom said in a statement.
In April 2017, San Diego-based Zavante announced that Contepo met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the Phase II/III ZEUS clinical trial in patients with cUTI, including acute pyelonephritis (AP). Contepo has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA in several indications, including cUTI, the companies said in a joint statement.
In addition to Contepo, Nabriva said it also expects to file an NDA for its own lefamulin. Lefamulin, a semi-synthetic pleuromutilin, is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. The experimental treatment hits its endpoints in two pivotal Phase III trials for the treatment of adults with community-acquired bacterial pneumonia (CABP).
As part of the deal Ted Schroeder, president and chief executive officer of Zavante, will assume the role of Nabriva CEO. Broom will continue to serve on Nabriva Therapeutics’ board of directors and serve as a management consultant to the company’s leadership team. As the two companies join together, Steven Gelone, Nabriva’s chief scientific officer and head of business & corporate development, has been named president and chief operating officer of Nabriva.
Under terms of the deal, Zavante received 8.2 million of Nabriva shares in an upfront payment. Additionally, Zavante’s stockholders are eligible to receive up to $97.5 million upon the achievement of specified regulatory and commercial milestones. That payment could be in the form of Nabriva’s ordinary shares, the companies said this morning. Shares of Nabriva are up more than 7 percent in premarket trading to $3.55.
