Fresenius Kabi and Phlow are joining together to boost U.S. supply of epinephrine injections through a novel onshoring drive.
The collaboration is billed as the “first-ever” end-to-end manufacturing pact of its kind and will see Phlow producing the active pharmaceutical ingredient (API) for the drug, while Fresenius Kabi will be responsible for performing the formulation and production of finished doses for hospitals and clinics.
The latter company has already been producing finished doses of the medicine in the U.S., but until Phlow got on board, there was no domestic source for epinephrine API, the companies explained in a Feb. 9 press release.
“Fresenius is a committed partner in advancing America’s vision of a fully domestic, end-to-end, supply chain for essential medicines, closing a vital gap in national security,” Joel Rosenstack, president of U.S. pharmaceuticals at Fresenius Kabi, said in the release.
Phlow, meanwhile, has been working alongside Fresenius Kabi to build “resilient, end-to-end supply assurance for essential medicines” for several years now, CEO Eric Edwards, M.D., Ph.D., noted. “This expanded collaboration is focused on securing a reliable domestic supply of epinephrine, one of the most critical, life-saving drugs used across emergency and acute care settings in the United States.”
Epinephrine injection is designated an essential medicine (PDF) by the World Health Organization (WHO) and the FDA and is used for the emergency treatment of allergic reactions and anaphylaxis in adults and children, as well as to increase arterial blood pressure in adults with hypotension linked to septic shock. Phlow and Fresenius’ pact looks to lessen the drug’s risk of chronic shortages in the U.S. and is designed to be scalable to other essential medicines as well, the companies said.
Phlow recently completed a U.S.-based validation campaign for epinephrine API, according to the release. The CDMO was formed in 2020 and operates out of a manufacturing campus in Virginia, describing itself as “purpose-built to help the U.S. government and forward-thinking pharmaceutical companies” navigate supply chain challenges, according to its website.
Fresenius Kabi, for its part, produces more than 70% of the medicines it sells in the U.S. from its production centers in Illinois, New York and North Carolina, and it has invested nearly $1 billion toward expanding U.S. pharmaceutical production since 2017, the company says on its own website. More than 70% of the units shipped by Fresenius Kabi are drugs listed on the FDA’s essential medicines list.
Together, the duo hopes to make epinephrine injections produced through the partnership available to U.S. hospitals by 2027.
Outside of its hospital use as an injection, epinephrine typically sees a spike in demand during the back-to-school season in August due to its popular use as an auto-injector for allergic reactions.
Last week, Aquestive Therapeutics’ attempt to market an oral epinephrine offering was swatted away by the FDA through a complete response letter that flagged issues with the drug's packaging and labeling guidance. Still, the company is committed to securing approval for the needle-free epinephrine option, which has been pegged as a potential blockbuster.