Move Strengthens America's Supply Chain and Supports COVID-19 Response
RICHMOND, Va. -- Phlow, a U.S.-based, public benefit drug manufacturing corporation, has 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.
This project has been funded with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (DHHS). 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 has initiated manufacturing chemical precursor ingredients, active pharmaceutical ingredients (APIs), 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 (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 United States' first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), 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."
"Years from now, historians will see this innovative project as a defining moment and inflection point for protecting American families‑—and our country—from current and future public health threats," said Peter Navarro, director of the White House Office of Trade and Manufacturing Policy. "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. We are now moving swiftly in Trump time to forge an American solution, one that leads with American ingenuity, American workers, and American factories all dedicated to ending our drug shortages and expanding drug manufacturing infrastructure for a healthy and secure future."
The threat of pandemics like COVID-19 has exposed the United States' heavy reliance on foreign pharmaceutical supply chains. Over 80 percent of APIs and chemical ingredients used in the U.S. to manufacture generics and over-the-counter drugs are produced abroad, the majority coming from China and India.
"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."
Over the past twenty years, due to economic and regulatory factors among others, manufacturing of active pharmaceutical ingredients and essential generic medicines in the U.S. sharply declined. This collaboration with United States Government provides security and sustainability to the nation's drug supply chain, enabling the U.S. to create a solution to combat the nation's chronic issue with generic drug shortages.
Led by Dr. Frank Gupton at the 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 help manufacture its API. This technology has not been widely adopted in the generic pharmaceutical industry but when used, it can increase the quality, safety, and volume of medicines, yielding lower costs for Americans.
"We believe this work can revolutionize America's generic drug manufacturing model by enabling Phlow to produce affordable ingredients used to manufacture essential medicines in the U.S.," said Dr. Gupton, co-founder of Phlow, chair of Virginia Commonwealth University's (VCU) Department of Chemical and Life Science Engineering and CEO of the Medicines for All Institute.
"As a strategic partner, VCU and the Medicines for All Institute will be able to develop and commercialize innovative chemical process technologies for Phlow to enable domestic end-to-end drug manufacturing with the ultimate goal of providing affordable, high-quality, and U.S. manufactured medicines to patients."
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.
"This partnership fits perfectly with Civica's mission to make essential generic medications accessible and affordable," said Martin VanTrieste, president and CEO of Civica Rx. "We thank Phlow, VCU and AMPAC for their collaboration and commitment to serving patients, and we thank the federal government for partnering with us to bring urgently needed advanced manufacturing capabilities for the production of essential generic drugs to the United States."
In order to begin rapidly producing medicines for patients in need, Phlow 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.
About Civica Rx
Civica Rx was established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare), in partnership with the Veteran's Administration, to reduce chronic generic drug shortages and related high prices in the United States. It exists in the public interest as a non-profit, non-stock corporation committed to stabilizing the supply of essential generic medications.
Today over 50 health systems are Civica members, representing more than 1200 hospitals with over 30% of the licensed hospital beds in the United States. In just over a year, Civica launched 20 sterile injectable medications and expects to launch another 20 medications this year, building toward 100 by 2023. Civica ensures it has dedicated manufacturing capacity for the medications that are most needed through redundant manufacturing and a strategic safety stock of medications.
About AMPAC Fine Chemicals
AMPAC Fine Chemicals (AFC) is a United States-based, custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates. AFC solves problems through technology and innovation to reliably deliver quality products that save and improve lives. With over 75 years of experience, AFC has mastered challenging chemistries, enabling us to provide the highest quality services to our customers. Our fully cGMP compliant facilities located in California, Texas, and Virginia specialize in process development, scale-up, and production from kilograms to multi-ton quantities. AFC has expanded its capabilities to include contract analytical services. These services are conducted at AMPAC Analytical, located near our headquarters in California.
About Virginia Commonwealth University and The Medicines for All Institute
The Medicines for All Institute (M4ALL), based at Virginia Commonwealth University College of Engineering in Richmond, Virginia, is committed to improving global access to high-quality medications by driving down production costs. By re-imagining manufacturing processes, the institute's chemical engineers and chemists optimize active pharmaceutical ingredient production and provide open access to manufacturers around the world to enhance the security of medicine supply chains. The institute was founded in 2017 with funding from the Bill & Melinda Gates Foundation.
Biomedical Advanced Research and Development Authority (BARDA)
Biomedical Advanced Research and Development Authority known as BARDA is part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats and is playing a leading role in the COVID-19 response efforts.