Eli Lilly lines up a blockbuster deal for Covid-19 antibody, right after it failed a NIAID trial - Endpoints News

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Two days af­ter Eli Lil­ly con­ced­ed that its an­ti­body bam­lanivimab was a flop in hos­pi­tal­ized Covid-19 pa­tients, the US gov­ern­ment is prepar­ing to make it a block­buster.

The phar­ma gi­ant re­port­ed ear­ly Wednes­day that it struck a deal to sup­ply the feds with 300,000 vials of the drug at a cost of $375 mil­lion — once it gets an EUA stamp from the FDA. And once that 2-month sup­ply deal is done, the gov­ern­ment has an op­tion on an­oth­er 650,000 dos­es on the same terms — which could po­ten­tial­ly add an­oth­er $812 mil­lion.

The gov­ern­ment is lin­ing up de­liv­ery of the 700 mg dose of the drug, even though the one study Eli Lil­ly points to for proof of ef­fi­ca­cy un­der­scores the drug — ob­tained from Ab­Cellera — did not work at that dose for re­cent­ly di­ag­nosed pa­tients. On­ly the 2800 mg dose was ef­fec­tive for the pri­ma­ry end­point, change from base­line in vi­ral load at day 11, with the low and high dos­es falling short of sig­nif­i­cance — though even that is a ques­tion­able as­sump­tion.

A num­ber of an­a­lysts re­marked that Lil­ly’s da­ta were mid­dling at best, with no dose de­pen­dent re­sponse to help make Lil­ly’s case. But Lil­ly said the da­ta were close enough, and used that low­er dose, which they can make more of, for their EUA ap­pli­ca­tion.

Lil­ly added that it has the man­u­fac­tur­ing in place to make a mil­lion dos­es of the drug by the end of 2021, with sup­plies ramp­ing up for glob­al de­liv­ery in Q1. The first 100,000 vials should be good to go al­most im­me­di­ate­ly af­ter the FDA acts, says the com­pa­ny, though the phar­ma gi­ant has al­so been cit­ed by reg­u­la­tors for qual­i­ty prob­lems with the man­u­fac­tur­ing fa­cil­i­ty that makes the an­ti­body.

An EUA is still a strong like­li­hood, even af­ter the NI­AID just shut­tered a study test­ing the drug in hos­pi­tal­ized pa­tients. Re­searchers ruled out a safe­ty is­sue, leav­ing the door open to an emer­gency au­tho­riza­tion for a drug that has been tout­ed by Pres­i­dent Trump. Lil­ly quick­ly fol­lowed up the tri­al fail­ure with a state­ment that re­searchers still be­lieve it works among less se­vere­ly af­flict­ed pa­tients — though the case for that is based on their BLAZE-1 study, where the 700 mg dose was in­ef­fec­tive.

Lil­ly CEO David Ricks not­ed that “we be­lieve bam­lanivimab could be an im­por­tant ther­a­peu­tic op­tion that can bring val­ue to the over­all health­care sys­tem, as it has shown a po­ten­tial ben­e­fit in clin­i­cal out­comes with a re­duc­tion in vi­ral load and rates of symp­toms and hos­pi­tal­iza­tions.”

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Eli Lilly lines up a blockbuster deal for Covid-19 antibody, right after it failed a NIAID trial - Endpoints News
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