News brief­ing: Eli Lil­ly com­pletes $1B+ Pre­vail buy­out; El­zon­ris ap­proved in Eu­rope for adults

Eli Lil­ly’s $1.04 bil­lion takeover of Pre­vail Ther­a­peu­tics is of­fi­cial­ly com­plete, the com­pa­ny an­nounced Fri­day.

The sides had en­tered in­to the buy­out agree­ment last month with Lil­ly fo­cus­ing on Pre­vail’s pipeline of gene ther­a­pies, high­light­ing two AAV9 pro­grams in Parkin­son’s dis­ease and fron­totem­po­ral de­men­tia as po­ten­tial win­ners. Lil­ly paid $22.50 per share, which amount­ed to an 82% pre­mi­um over the pre­vi­ous day’s clos­ing price and a 117% pre­mi­um over Pre­vail’s 60-day av­er­age.

The deal al­so in­clud­ed a $4 con­tin­gent-val­ue right (CVR) based on one of the AAV9 gene ther­a­pies re­ceiv­ing ap­proval in one of the US, UK, Japan, France, Ger­many, Italy or Spain by the end of 2024. If that dead­line isn’t met, the val­ue of the CVR would drop by 8.3 cents each month be­fore even­tu­al­ly ex­pir­ing by the end of 2028.

It was Lil­ly’s sec­ond big M&A move in the last three months of 2020 af­ter the phar­ma picked up Dis­arm Ther­a­peu­tics and its SARM1 in­hibitors in Oc­to­ber for $135 mil­lion in cash, plus up to $1.225 bil­lion in mile­stones.

El­zon­ris tacks on ap­proval in Eu­rope for adult pa­tients

A lit­tle over two years af­ter re­ceiv­ing FDA ap­proval, El­zon­ris is now ap­proved to use in Eu­rope.

The Eu­ro­pean Com­mis­sion for­mal­ly OK’ed the drug late Thurs­day night, mak­ing it the first CD-123 ther­a­py ap­proved on the con­ti­nent. In Eu­rope, El­zon­ris is in­di­cat­ed as a monother­a­py for the first-line treat­ment of adults with blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm.

US reg­u­la­tors green­lit the drug back in Oc­to­ber 2018, and El­zon­ris is avail­able for Amer­i­cans aged two and old­er.

Stem­line Ther­a­peu­tics de­vel­oped the drug, but the com­pa­ny is now a part of Ital­ian phar­ma­ceu­ti­cal com­pa­ny The Menar­i­ni Group. Stem­line in­vit­ed con­tro­ver­sy while the drug was still in clin­i­cal tri­als, fail­ing to tip in­vestors off about a pa­tient death in the piv­otal study.

The FDA nonethe­less waved the drug through on a small set of da­ta. El­zon­ris’ OK came af­ter it post­ed wide­ly vary­ing re­sults from two drug co­horts in a tiny sin­gle-arm study.

Hu­mani­gen signs deal to use BAR­DA man­u­fac­tur­ing sites for lenzilum­ab in Covid-19

Hu­mani­gen, a for­mer com­pa­ny of “Phar­ma Bro” Mar­tin Shkre­li, has been de­vel­op­ing its lenzilum­ab can­di­date in con­junc­tion with the De­part­ment of De­fense for Covid-19 since No­vem­ber 2020. Now, the com­pa­ny has ac­cess to new man­u­fac­tur­ing sites.

Hu­mani­gen’s deal with CRA­DA is now co-signed by BAR­DA, al­low­ing the com­pa­ny to pro­duce the ex­per­i­men­tal drug with BAR­DA’s sites. Lenzilum­ab is cur­rent­ly in a Phase III tri­al for Covid-19 and Hu­mani­gen is ex­pect­ed to seek an EUA in the near fu­ture.

Should the can­di­date work as planned, it will pre­vent and treat the cy­tokine storms as­so­ci­at­ed with Covid-19. In Oc­to­ber, the mon­o­clon­al an­ti­body was al­so tapped by the NI­AID to par­tic­i­pate in the AC­TIV-5 Big Ef­fect Tri­al, eval­u­at­ing its ef­fi­ca­cy in com­bi­na­tion with Gilead’s Vek­lury.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.