Eli Lil­ly re-ups di­ver­si­ty pledge, pitch­ing in $30M to ven­ture fund for mi­nor­i­ty-owned health­care firms

The fight against racial in­jus­tice spurred by a se­ries of high-pro­file shoot­ings of Black men by po­lice ear­li­er this year put Big Phar­ma and health­care — in­dus­tries tar­get­ed for their lack of di­ver­si­ty — in the hot seat. Eli Lil­ly made an ear­ly pledge to change its ways and put more back in­to the com­mu­ni­ty, and now it’s con­tin­u­ing to make good on that com­mit­ment.

Lil­ly will in­fuse $30 mil­lion in­to the Un­seen Cap­i­tal Health Fund, a ven­ture fund look­ing to in­vest in ear­ly-stage mi­nor­i­ty-owned health­care com­pa­nies that have been his­tor­i­cal­ly “un­seen” by the in­vest­ment com­mu­ni­ty, the phar­ma said Fri­day.

Joshua Smi­ley

“The pan­dem­ic has re­in­forced our un­der­stand­ing that there is un­equal treat­ment and un­equal ac­cess to health­care in un­der­served com­mu­ni­ties, made worse by a lack of fi­nan­cial in­vest­ment for the promis­ing ideas that rise up from with­in these com­mu­ni­ties,” Lil­ly CFO Joshua Smi­ley said in a re­lease.

With Lil­ly’s in­vest­ment, Un­seen is well on its way to reach­ing its goal of rais­ing $100 mil­lion, which it will dole out to 50 tar­get­ed mi­nor­i­ty-owned busi­ness­es. Lil­ly de­scribed the in­vest­ment as a po­ten­tial “mod­el” for how Big Phar­ma play­ers could co­op­er­ate with small com­pa­nies to make mean­ing­ful change at the lo­cal lev­el.

Spurred in part by the po­lice killing in June of George Floyd in Min­neapo­lis, Lil­ly was one of a group of drug­mak­ers that pledged to ad­dress sys­temic racial in­jus­tice, in­clud­ing a lack of di­ver­si­ty in the bio­phar­ma and health­care in­dus­tries.

David Ricks

In an Oc­to­ber open let­ter, CEO David Ricks un­veiled his com­pa­ny’s plans to join the “In­dy Racial Equal­i­ty Pledge” — a coali­tion of cen­tral In­di­ana firms that agreed to com­mit re­newed re­sources to achiev­ing racial equal­i­ty in their work­forces and in­vest­ing in the com­mu­ni­ty at large.

“Cor­po­ra­tions and the civic com­mu­ni­ty must ac­tive­ly join the fight for racial jus­tice,” Ricks wrote. “By us­ing our col­lec­tive voice and in­flu­ence, we can be part of the so­lu­tion — and help cre­ate the change we want to see with­in our own or­ga­ni­za­tions and with­in our com­mu­ni­ties.”

As part of that pledge, Ricks out­lined plans to in­crease the com­pa­ny’s work­force from 10% to 13% to more track more in line with na­tion­al de­mo­graph­ics, dou­ble the com­pa­ny’s spend with African-Amer­i­can sup­pli­ers by the end of 2022, in­vest $1 mil­lion in­to a cap­i­tal growth fund for Black-owned busi­ness­es and more.

In June, just days af­ter Floyd’s death, the Lil­ly Foun­da­tion pledged $25 mil­lion and 25,000 hours of its em­ploy­ees’ time over five years. The com­pa­ny didn’t spec­i­fy at the time how those funds would be used.

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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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.

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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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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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.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.