The Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS), has entered into a $354-million agreement with Phlow Corporation, a Richmond, Virginia-based pharmaceutical manufacturing company, to manufacture in the US medicines needed during the COVID-19 response and future public health emergencies. The total contract value awarded to Phlow is up to $812 million which includes an initial four-year base award of $354 million with an additional $458 million included as potential options for medicines supply.

Under the four-year, $354-million agreement, BARDA and a team of private-industry partners led by the Phlow will manufacture the supplies for medicines for patients hospitalized with COVID-19. The contract can be extended for up to a total of $812 million over a total of 10 years to maintain the system and supplies.

The US government and Phlow are developing a prioritized list of active pharmaceutical ingredients (APIs) and finished medicines needed by healthcare systems for the COVID-19 response.

The drug ingredients will be manufactured at facilities in the US, including a new facility to be built in Virginia. Phlow has partnerships with pharmaceutical supply and manufacturing organizations, including AMPAC Fine Chemicals (part of SK pharmteco), a custom API manufacturer, Civica Rx, a non-profit generic-drug company, and the Medicines for All Institute at Virginia Commonwealth University’s College of Engineering, a non-profit organization focused on advancing drug-manufacturing processes.

Phlow and its team will use continuous manufacturing and will complete a technology transfer of novel continuous manufacturing processes to organizations or businesses designated by the US government.

In addition to producing the APIs, the team will expand manufacturing capability in the US to provide further capacity for producing finished generic drugs. The team will be able to provide US healthcare systems with finished, sterile, injectable generic medicines at risk of shortage.

Phlow and its partners have initiated manufacturing chemical precursor ingredients, APIs, and finished dosage forms for over a dozen essential medicines to treat hospitalized patients with COVID-19-related illnesses. The partnership with HHS/ASPR/BARDA enables Phlow with its partners, to deliver over 1.6 million doses of five essential generic medicines used to treat COVID-19 patients to the US Strategic National Stockpile (SNS), including medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain essential antibiotics.

Phlow is also building the US’ first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines in the US to reduce US dependency on foreign nations to support its drug supply chain, according to information from Phlow.

Civica Rx, a non-profit pharmaceutical company that was formed to combat drug shortages and price spikes in hospitals, will manufacture the finished dosage product on the same site as Phlow’s precursor and API production. Phlow will work with Civica’s network of more than 1,200 hospitals, consisting of over 30% of licensed hospital beds in the US to make these medicines available to healthcare systems.

Phlow is partnered with AMPAC Fine Chemicals, a CMDO offering commercial continuous processes and APIs and precursor chemical ingredients, to produce ingredients used in the manufacturing of essential medicines. Phlow also is working to build an advanced manufacturing capability in Virginia and sterile injectables manufacturing facilities.

Medicines for All Institute, based at Virginia Commonwealth University College of Engineering, the team will use flow chemistry and other continuous advanced manufacturing processes to manufacture the APIs.

Source: The US Department of Health and Human Services and Phlow Corporation