Little-known Drug Manufacturer Gets Big Contract For COVID-19 Response
Source:

Jacob Bell, BioPharma Dive

May 21, 2020

Dive Brief:
Phlow, a Richmond, Virginia-based corporation that describes itself as a public benefit drug manufacturer, announced Tuesday the federal government will pay it hundreds of millions of dollars to make essential medicines that are at risk of shortage, including medicines used to respond to the coronavirus pandemic.
The money comes from BARDA, or the Biomedical Advanced Research and Development Authority, which is part of the U.S. Department of Health and Human Services. The contract starts with a four-year award of $354 million, which can be extended to a 10-year award worth $812 million total.
Phlow said BARDA’s money has already allowed it to manufacture 1.6 million doses of five essential generic medicines used to treat COVID-19 patients. The medicines, which include a sedative, a pain management drug, and an antibiotic, were delivered to the U.S. Strategic National Stockpile, Phlow said. The corporation is working in partnership with Civica Rx, AMPAC Fine Chemicals and Virginia Commonwealth University’s Medicines for All Institute.

Dive Insight:
The contract unveiled Tuesday is one of the largest ever awarded by BARDA. While that’s noteworthy in itself, it’s made more so by the fact that Phlow is a relatively unknown entity in the drug manufacturing world.

Phlow was founded in January, though a spokesperson said the corporation has been working for more than a year to address its stated mission of reducing the U.S.’ dependence on foreign supply chains. The spokesperson also told BioPharma Dive that Phlow has been communicating with government officials about the U.S.’ pharmaceutical supply for more than a year.

Phlow’s aim is in line with longstanding goals of the Trump administration to boost drug production in the states. That push has taken on a greater sense of urgency since the novel coronavirus spread to the U.S.; just last week, the president’s administration unveiled “Operation Warp Speed,” a government-led effort to hasten the manufacturing preparations that would be required to quickly make and distribute an effective coronavirus vaccine, should one become available.

“For far too long, we’ve relied on foreign manufacturing and supply chains for our most important medicines and active pharmaceutical ingredients while placing America’s health, safety, and national security at grave risk,” said Peter Navarro, director of the White House Office of Trade and Manufacturing Policy, in a Tuesday statement.

Navarro has long advocated for on-shoring U.S. manufacturing. A large amount of the active ingredients used to make small molecule drugs are made internationally, with much coming from China and India. Companies in those countries, though, have run into repeated issues with the quality of their manufacturing.

Phlow says it’s working to build the first Strategic Active Pharmaceutical Ingredients Reserve in the U.S., which would serve as a national stockpile to secure “key” manufacturing ingredients for the “most essential” medicines.

With help from its partners, Phlow said it has begun manufacturing the ingredients and finished dosage forms for more than a dozen essential medicines used to treat patients hospitalized with illnesses related to COVID-19, the disease caused by the novel coronavirus. Phlow said many of these medicines are imported to the U.S., but are currently in short supply.

Phlow’s business revolves around a type of continuous manufacturing process called “flow” chemistry. Though it’s currently using AMPAC Fine Chemicals’ sites to produce drug ingredients, the spokesperson said its first facility should be operational in the next 12 months.

Phlow sports a team of veteran healthcare executives. Eric Edwards, board member and CEO, had previously co-founded Kaleo, a Richmond-based drug company best known for developing a rival autoinjector to Mylan’s EpiPen and which later came under scrutiny for steep price hikes.

Other members of the board include Martin Van Trieste, CEO of CivicaRx; Frank Gupton, CEO of the Medicines for All Institute; and Rosemary Gibson, board chair of Altarum, a research and consulting organization that serves nonprofit clients focused on healthcare.

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