Phlow, a Richmond, Virginia-based, drug manufacturing corporation, received federal government funding of $354 million for advanced manufacturing of America's most essential medicines at risk of shortage, including medicines for the COVID-19 pandemic response.
In order to begin rapidly producing medicines for patients in need, Phlow said it partnered with AMPAC Fine Chemicals, a leader in commercializing continuous processes, and a custom manufacturer of API and precursor chemical ingredients based in the U.S. Phlow is working with AFC to produce ingredients used in the manufacturing of essential medicines, and is working to build an advanced manufacturing capability in Virginia and Sterile Injectables Manufacturing Facilities.
"In the midst of this pandemic, America needs a reliable source of high quality, domestically manufactured, affordable pharmaceuticals and their key ingredients," said Eric Edwards, MD, PhD, co-founder, president and CEO, Phlow. "This advanced manufacturing capability will significantly fortify our nation's pharmaceutical supply chain for critical medicines, including many required to treat patients hospitalized with COVID-19."
The project has been funded with federal funds from the Biomedical Advanced Research and Development Authority, part of the office of Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
According to company officials, the total contract value awarded to Phlow is up to $812 million which includes a four-year base award of $354 million with an additional $458 million included as potential options for long-term sustainability.
With its strategic partners, Civica Rx, Virginia Commonwealth University's Medicines for All Institute, and AMPAC Fine Chemicals, Phlow said it has initiated manufacturing chemical precursor ingredients, active pharmaceutical ingredients, and finished dosage forms for over a dozen essential medicines to treat hospitalized patients with COVID-19-related illnesses. Many of these medicines are in shortage and have previously been imported from foreign nations.
The partnership with HHS/ASPR/BARDA immediately enabled Phlow, with the help of its partners, to deliver over 1.6 million doses of five essential generic medicines used to treat COVID-19 patients to the U.S. Strategic National Stockpile, including medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain essential antibiotics.
Phlow said it is also building the United States' first Strategic Active Pharmaceutical Ingredients Reserve, a long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines on U.S. soil, reducing America's dependency on foreign nations to support its drug supply chain.
"BARDA has long focused on expanding pharmaceutical manufacturing infrastructure in the United States, not only to develop and produce vaccines, but also for essential medicines, and their key ingredients used to make these drugs," said BARDA Acting Director, Dr. Gary Disbrow. "Collaborating with Phlow and its partners is an important step in expanding our manufacturing of strategic APIs and critical medicines at-risk of shortage."
Civica Rx, the nation's leading non-profit pharmaceutical company, was formed to combat drug shortages and price spikes in hospitals. This contract enables Civica to manufacture the finished dosage product on the same site as Phlow's precursor and API production and work with Civica's network of more than 1200 hospitals, consisting of over 30% of licensed hospital beds in the U.S., to make these medicines immediately available to doctors and patients who need them.