Nanotherapeutics Awarded BARDA Fill-Finish Manufacturing Network Task Orders to Develop Two FDA Drug Shortage Products

Nanotherapeutics, Inc. has received two new Task Orders from The United States Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) Fill-Finish Manufacturing Network’s (FFMN) Pilot Production program, for the Center for Drug Evaluation and Research (CDER) pathway regulated products.

To address the need, BARDA, in consultation with the FDA’s Drug Shortage Staff, selected several products from the (FDA) Drug Shortage Index, for the network contractors to propose on. Upon completion of the work, and a successful filing with the regulators at FDA/CDER, this effort will have a potential secondary benefit of increasing fill & finish manufacturing capacity for these products within the US. Both Task Orders are for 18 months and include process validation lots and FDA filing. This project is funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201300018I.

These new Task Orders could support FDA’s and HHS’ mission of Drug Shortage Remediation by allowing for the rapid response to shortages of life saving products that have limited to no availability on the commercial market, or which are identified as being vulnerable to shortage. Given that drug shortages can pose a significant threat to public health, delaying, and in some cases even denying critically needed care for patients is a major concern and thus, this issue remains a top priority for FDA.

In September 2013, BARDA established the FFMN to facilitate production of clinical investigational lots of various medical countermeasures (MCM) that are in development and to boost the nation’s ability to manufacture influenza vaccine quickly in a pandemic. At the time, Nanotherapeutics was awarded one of four BARDA contracts to provide filling and finishing capabilities for influenza vaccines and other public health emergency products to address national security and to augment public health needs on a cost-effective, reliable, and sustainable basis. Since that time, Nanotherapeutics has also been awarded a Task Order for fill-finish of Mapp Biopharmaceutical’s ZMapp 3-mAb cocktail mix, in clinical development for the treatment of the Ebola Virus Disease.