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Paratek to receive up to $285M to develop Nuzyra to treat anthrax inhalation


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Paratek to receive up to $285M to develop Nuzyra to treat anthrax inhalation

The U.S. government agreed to give Paratek Pharmaceuticals Inc. up to $285 million in a contract to develop its oral medicine Nuzyra for treating anthrax inhalation.

The Biomedical Advanced Research and Development Authority, or BARDA, will give the Boston-based company an initial $59 million to develop its medicine and to provide 2,500 treatment courses of Nuzyra, also known as omadacycline, to add to the Strategic National Stockpile for use against potential biological weapons.

The contract offers future funding in the form of $77 million for the drug's post-market studies slated for April 2020; $20 million related to manufacturing obligations, scheduled for June 2020; potential milestone-based funding for $13 million to develop Nuzyra for anthrax treatment; and up to $115 million for as many as 7,500 additional courses of Nuzyra for the national stockpile.

The contract runs five years with an option to extend it to a decade and is offered in conjunction with the Department of Health and Human Services and Office of the Assistant Secretary for Preparedness and Response.

The contract is offered as part of BARDA's Project Bioshield, which was introduced by the U.S. government to buy and support the development of products that protect against biological weapons.

In October 2018, the U.S. Food and Drug Administration approved Paratek's Nuzyra to treat acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

A year later, the company withdrew its application for marketing approval in Europe as the European Medicines Agency said the company would have to complete another study to earn a nod for the pneumonia indication. Weeks later, the medicine failed to beat generic medication in treating urinary tract infections in two mid-stage studies.