Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

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

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.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Tim Miller, Forge Biologics CEO

CNS-fo­cused gene ther­a­py biotech forges man­u­fac­tur­ing deal for hear­ing loss drug

A growing gene therapy company is teaming up with one of the largest gene therapy manufacturers to get its drug into patients in clinical trials.

Myrtelle announced on Monday that it inked a deal with Forge Biologics to make Myr-201, a gene therapy indicated for monogenic hearing loss. The target patient population, Myrtelle said, is people with a type of hearing loss called DFNB8, or autosomal recessive deafness 8.

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Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, setting up a key vote ahead of a Feb. 28, 2023 PDUFA date.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Car­olyn Bertozzi (Illustration: Assistant editor Kathy Wong for Endpoints News)

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

Carolyn Bertozzi, predicted by some to become a Nobel laureate, clinched one of the world’s top awards in the wee hours of Wednesday, winning the Nobel Prize in Chemistry alongside a repeat winner and a Copenhagen researcher.

The Stanford professor, Morten Meldal of University of Copenhagen and 2001-awardee K. Barry Sharpless of Scripps shared the prize equally. The Nobel is sometimes split in quarters and/or halves.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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