Romark Laboratories has been awarded a contract with the U.S. Department of Health and Human Services (HHS) to complete the development of NT-300 (nitazoxanide) for acute uncomplicated influenza. The contract, valued at $44 million, will be administered through the Biomedical Advanced Research and Development Authority (BARDA), an agency within the Office of the Assistant Secretary for Preparedness and Response.
BARDA selected Romark for its development plan that includes a novel mechanism of action targeting host factors with the potential for broad-spectrum antiviral activity. NT-300 is administered orally, and it is being proposed for treatment of seasonal as well as pandemic influenza.
Romark will provide non-clinical and clinical development, as well as regulatory activities required to submit and manage the NDA. Romark's Phase III trial will evaluate the efficacy and safety of NT-300 or NT-300 plus oseltamivir compared to a placebo or to oseltamivir alone in treating outpatients with acute uncomplicated influenza.
"There is a pressing need for new drugs to treat influenza," said Jean-Francois Rossignol, M.D., Ph.D., chairman and chief science officer of Romark. "BARDA plays an important role in the advanced development of new countermeasures for public health threats such as pandemic influenza, and we are pleased to have the opportunity to work with them."