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.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

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UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

James Garner, Kazia CEO (PR Newswire)

Kazia swipes an ex-Sanofi mol­e­cule for £1M up­front as they look to repli­cate their Genen­tech snag

Kazia has spent most of its young life trying to develop a single Genentech castoff it swiped for $5 million into a brain cancer drug. Now, with that molecule in a pivotal trial, the Aussie biotech is adding another old Big Pharma asset to its reserves.

Kazia announced Monday they in-licensed a small molecule called EVT801 from Evotec for a nominal upfront fee – $1.4 million — and $428 million in potential milestones. The company said they plan to launch a Phase I trial for the drug, a new VEGFR inhibitor, later this year.

Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

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When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.