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www.fdanews.com/articles/197586-paratek-advances-plan-to-create-domestic-supply-of-its-antibiotic-nuzyra

Paratek Advances Plan to Create Domestic Supply of Its Antibiotic Nuzyra

June 11, 2020

Partly in response to the COVID-19 pandemic, HHS is partnering with a Boston-based drugmaker to create a domestic supply chain that doesn’t rely on foreign sources for active pharmaceutical ingredients.

The genesis of the partnership is a December 2019 contract between Paratek Pharmaceuticals and HHS’ Biomedical Advanced Research and Development Authority (BARDA) for the development and domestic manufacturing of the drugmaker’s antibiotic Nuzyra (omadacycline).

Prior to this pandemic, Paratek nabbed a $285 million three-year contract with BARDA to develop and manufacture Nuzyra for the treatment of pulmonary anthrax. Under the terms of the contract, BARDA would also procure 10,000 courses of the drug for the Strategic National Stockpile.

But HHS’ focus on creating a domestic supply chain for responding to this pandemic has raised the stakes, and BARDA confirmed that it issued $20 million of the promised funding on April 1 to support domestic manufacturing of Nuzyra.

Both Paratek and BARDA have declined further comment. But this contract isn’t HHS’ only move on the supply chain front.

HHS last week awarded Maryland-based drugmaker Emergent BioSolutions $628 million to manufacture COVID-19 vaccines at its Bayview, Baltimore Camden, and Rockville facilities (DID, June 2).

Last month, the department signed a $354 million contract with Virginia based startup Phlow Corporation to produce APIs and finished drugs to create a new Strategic Active Pharmaceutical Ingredients Reserve (DID, May 20). — Jordan Williams