Candidates: Various generic therapeutics against COVID-19
Types: Not specified
Status: Phlow, a public benefit drug manufacturing corporation, announced May 19 that it received a commitment of up to $812 million over 10 years from the Biomedical Advanced Research and Development Authority (BARDA) toward advanced manufacturing of generic COVID-19 therapeutics. The commitment consisted of a four-year base award of $354 million with an additional $458 million in potential option payments for long-term sustainability.
Working with strategic partners Civica Rx, a not-for-profit generic drug and pharmaceutical company; Virginia Commonwealth University’s Medicines for All Institute; and AMPAC Fine Chemicals, Phlow said it has begun 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. Phlow has not detailed those therapeutics except to say many are now in short supply, and have been previously imported from outside the U.S.
Phlow said it was able, with help from its partners, to deliver over 1.6 million doses of five unspecified “essential” generic treatments for COVID-19 to the U.S. Strategic National Stockpile (SNS). The medicines, Phlow said, include “medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain essential antibiotics.”
Phlow has also begun building the nation’s first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a long-term, national stockpile designed to house key ingredients for manufacturing “the most essential medicines” on U.S. soil, reducing dependency on foreign nations. According to BARDA, more than 80% of APIs and chemical ingredients used in the U.S. to manufacture generics and over-the-counter drugs are produced overseas, mostly in China and India.
Edwards is a co-founder, along with twin brother Evan Edwards, of Kaléo, whose products included the Evzio, an auto-injectable pen designed to deliver naloxone. Kaléo quintupled the price of Evzio in 2016, prompting members of Congress to ask the company why, in light of the opioid epidemic; Kaléo said it did so in order to fund its patient assistance program for Evzio. Phlow and Eric Edwards have declared that he had no say over pricing at Kaléo, which the Edwards brothers co-founded in 2015 to develop and market a competing product to EpiPen, Auvi-Q. The brothers grew up with life-threatening food allergies and both almost had near-fatal anaphylaxis.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: