The US Federal Government will award up to $ 812M to new company Phlow Corporation ( Richmond , VA , US ) to manufacture Covid – 19 medicines and other therapies that are at risk of shortage . The Department of Health and Human Services ( HHS ) ( Washington DC , US ) says it is bringing pharmaceutical manufacturing back to the US , but other groups have questioned why the grant was awarded seemingly without competition to a new company that will need time to build facilities rather than to an established CMO .
The Biomedical Advanced Research and Development Authority ( BARDA ), which is a part of the HHS , is providing the funds via an initial four – year award of $ 354M , with the potential to be followed by an additional $ 458M , Phlow announced in May .
Phlow will lead a collaboration with Civica Rx ( Salt Lake , UT , US ), a non – profit pharma company , AMPAC Fine Chemicals ( Rancho Cordova , CA , US ), and Virginia Commonwealth University ‘ s Medicines for All Institute to manufacture more than 12 different medicines .
Phlow and Ampac will produce pharmaceutical precursors and APIs . At first , Civica Rx will manufacture finished dose forms including vials and syringes via its pre – existing network of Civica manufacturing partners , and later by building its first production facility , the company said .
Phlow was founded as recently as January 2020 , and it will need to build “ an advanced manufacturing capability in Virginia and sterile injectables manufacturing facilities ,” next to Ampac ’ s site in Virginia , the company said in a statement . Civica will also build its own finished dose sterile injectable facility nearby to manufacture drugs approved via its own ANDAs , CEO Martin VanTrieste told this publication . Civica Rx was formed in 2018 to combat drug shortages and price spikes by using partner CMOs to produce Civica – labeled generic drugs ( B / POR , September 2018 ).
Robby Demeria , Phlow Corporation Chief of Staff , told this publication that the facility will take 12 – 18 months to build . This has raised questions about whether Phlow ’ s and Civica ’ s sites will be ready to manufacture a Covid – 19 therapy in the required timeframe . Gil Roth , President of the Pharma & amp ; Biopharma Outsourcing Association (PBOA ), commented , “ With a contract like this , the devil is in the details . PBOA member companies and I are certainly interested in learning more about the parameters of this agreement , and why it was conducted in a no – compete manner .”
The contract received just one bid , according to the government website USAspending . gov . However , Demeria denied that Phlow made the only bid for the grant . “Phlow submitted a proposal under BARDA ’ s Board Agency Announcement for advanced manufacturing technologies … along with other companies ( unknown exact number ),” he wrote in an email statement .
While Phlow is building its API facilities , “AMPAC Fine Chemicals will manufacture these essential API through traditional batch manufacturing processes and store the API in reserve ,” Demeria said , adding “ If there is a second wave of Covid – 19 this fall , Phlow will send the stored API to fill / finish partners for final dosage and then to the SNS [ US Strategic National Stockpile ] for distribution .”
When asked whether Civica ’ s facility will be operational in time to address the Covid – 19 crisis , VanTrieste told this publication that while building manufacturing sites is a long – term goal , the short – term aim is to build medicine stockpiles through other means . Civica is currently working with five CMOs and is in negotiations with more to outsource the manufacture of generic drugs “ to re – enter the market or increase existing capacity .” Civica is also pursuing Abbreviated New Drug Applications ( ANDAs ) for generic drugs that will be manufactured by CMOs . Its first ANDA drugs will be manufactured by Patheon ( owned by Thermo Fisher ; Waltham , MA , US ) in early 2021 , he said . When Civica ’ s own sterile injectable facility is built , it will manufacture its own ANDA drugs , he said .
Phlow Corporation: Shunning Foreign Supply Chains
Phlow Corporation stated that it is contributing to a Strategic Active Pharmaceutical Ingredients Reserve ( SAPIR ), a stockpile that it claims will reduce US dependence on foreign manufacturing . The Trump administration has touted the collaboration as bringing pharmaceutical manufacturing back to the US . Ampac , although based in California , is owned by South Korean holding company SK Holdings ( Seoul , South Korea ).
“ 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 . Navarro is a controversial advisor to President Trump , having been accused by others in the administration of lying to the President about the feasibility of proposed trade policies , according to a Washington Post profile .
Others have criticised attempts to limit the use of foreign supply chains . “ It ’ s a good thing pharmaceutical manufacturing supply chains are spread out around the world ,” said Pharmaceutical Research and Manufacturers of America ( Phrma )’ s ( Washington DC , US ) director of public affairs , Nicole Longo , in an editorial on the organisation ’ s website . “ While often overlooked , geographic diversification of the supply chain is beneficial , especially in the time of pandemics , because of the flexibility it gives companies when they need it most .”
Margarida Jorge , campaign director , Lower Drug Prices Now , was more forthright . “ This White House seems to have an open spigot of taxpayer dollars going to drug corporations that profiteer off of pandemics ,” she commented . “ They ’ re gearing up to give the largest award in history to a corporate executive who quintupled the price of naloxone in the middle of the opioid epidemic . Yet again , the administration is handing over taxpayer dollars away to a drug corporation with no strings attached and no guarantee that we ’ ll get affordable access to the medicines developed with our money .”
Phlow describes itself as a “ public benefit pharmaceutical manufacturing company dedicated to providing high – quality , low – cost pharmaceuticals .” Its CEO , Eric Edwards , is the co – founder of kaleo ( Richmond , VA , US ), which was criticised by a US Senate subcommittee in 2018 for raising the price of its opioid overdose antidote naloxone .
In response to Jorge ’ s “ profiteering ” accusation , VanTrieste noted that the drugs Civica produces are identified by healthcare priorities and do not have a high return on investment .
The drugs to be manufactured via the collaboration include neuromuscular blocking agents , sedation agents , and pain medications . For more on Covid – 19 drug shortages , see GlobalData ’ s PharmSource Bio / Pharmaceutical Outsourcing Report , June 2020 .