CONTINUUS Pharmaceuticals Secures $69.3 Million Government Contract to Manufacture Critical Medicines in the U.S.
DoD/HHS contract will enable onshore production of three vital medicines to treat critically ill patients, including those with COVID-19.
Company will build the first GMP-certified end-to-end manufacturing facility using its proprietary technology for the production of small-molecule medicines.
CONTINUUS Pharmaceuticals Inc., an innovator in transforming production of small-molecule pharmaceuticals with its proprietary Integrated Continuous Manufacturing (ICM) technology, with participation by I.M.A. Industria Macchine Automatiche S.p.A., today announced receipt of a $69.3 million U.S. government contract to facilitate domestic production of three vital medicines used to treat critically ill patients, including those with COVID-19. The contract, awarded by the Department of Defense (DoD) in conjunction with the Department of Health and Human Services (HHS), will also enable construction of the country’s first Good Manufacturing Practices (GMP)-certified facility for end-to-end, ICM-driven production of small-molecule drugs, including marketed products, generic medications, and investigational therapies through all phases of clinical trials and a product’s lifecycle.
“We are honored to receive this important contract from the Departments of Defense and Health and Human Services, both of which recognize the urgency of ramping up domestic production of critical-care medicines,” said Salvatore Mascia, Ph.D., founder and chief executive officer of CONTINUUS Pharmaceuticals. “In addition to streamlining continuous, environmentally friendly, and cost-efficient production of these medicines, this contract will help us build a state-of-the-art facility that will address urgent pharmaceutical supply chain issues, ultimately speeding the delivery of high-quality, affordable medications to patients, while also creating U.S.-based jobs.”
“I’m excited to see yet another Massachusetts-based company be recognized for the important role they can play in the fight against COVID-19 and future public health crises,” said Massachusetts Housing and Economic Development Secretary Mike Kennealy. “Through efforts like the Manufacturing Emergency Response Team and the Accelerating Coronavirus Testing Solutions program, our Administration has been advancing both homegrown supply chains and scientific innovations, and this new DoD/HHS contract is yet another testament to the Commonwealth’s strong life sciences and biomanufacturing leadership.”
The DoD/HHS contract underscores the need for rapid and reliable U.S.-based production of high-quality, in-demand medicines. Offshore drug manufacturing carries significant risks arising from inconsistent quality, duplicative active pharmaceutical ingredient (API) manufacturing for the same drug at different facilities, and the difficult logistics of quality-control monitoring by the U.S. Food and Drug Administration (FDA) and other regulatory agencies.
To address these and related issues, the FDA previously awarded CONTINUUS a contract to help establish a science-based approach to devising regulatory guidelines for continuous drug manufacturing. CONTINUUS’ ICM technology reduces drug production time from many months or even years to just a few days, which will help to mitigate hospital and pharmacy shortages of critical drugs. This unique approach also enables manufacturing of multiple drugs in quick succession with lines that can be easily transported between locations, which the company refers to as “MoP” (Mobile Pharmaceuticals) – further addressing longstanding supply chain problems in pharmaceutical production.
“Beyond addressing national security needs in obtaining critical-care medicines from overseas, we will work with hospitals and pharmacies to ensure that other key drugs, such as epinephrine and ciprofloxacin, are never again in shortage,” said Bayan Takizawa, MD, co-founder and chief business officer of CONTINUUS. “The impact on the pharmaceutical industry will also be significant, as our technology eliminates the typical delays associated with scale-up, allowing companies to accelerate development of small-molecule drugs for faster delivery to patients in need.”
CONTINUUS will break ground for a new facility in Woburn, Mass. later this month and plans to make the plant fully operational within two years.