The new CEOs in bio­phar­ma are join­ing the big play­ers at the bil­lion-dol­lar chip ta­ble

Call it new CEO syn­drome.

Every time a new CEO takes over at a bio­phar­ma com­pa­ny of some size, the in­stinc­tive re­sponse is to look for some deal or deals that will help set the tone for the new leader, prefer­ably one that is pre­dic­tive of a bold — but not reck­less — de­sign on fu­ture growth.

Lars Fruer­gaard Jor­gensen, No­vo

So per­haps it was no great sur­prise to see No­vo Nordisk fig­ure in­to the lat­est round of buy­out ru­mors — this time fo­cused on Glob­al Blood Ther­a­peu­tics and its lead drug for sick­le cell dis­ease. No­vo’s new CEO, Lars Fruer­gaard Jor­gensen, per­haps telling­ly wouldn’t com­ment on that to Reuters. But he had plen­ty to say about his in­ter­est in deal­mak­ing.

“We will more and more have to do deals like any oth­er com­pa­ny to make sure we have a broad­er plat­form to grow on,” Jor­gensen told Reuters’ vet­er­an scribe Ben Hirschler. “In my view we should do small­er deals; low sin­gle-dig­it bil­lions of dol­lars.”

So more of the ever-pop­u­lar biotech bolt-ons you can find at the bil­lion-dol­lar chip ta­ble, not big M&A.

Pre­dictably, that strat­e­gy in­cludes a taste for deals re­lat­ed to blood dis­eases, where the com­pa­ny is work­ing on he­mo­phil­ia, straight through to its core fo­cus on di­a­betes and obe­si­ty. And it’s a de­par­ture from the un­re­lent­ing fo­cus that his pre­de­ces­sor, the straight talk­ing Lars Re­bi­en Sorensen, had on the com­pa­ny’s pipeline drugs.

David Ricks, Lil­ly

Jor­gensen is just the lat­est mem­ber of the new CEO club, join­ing new Eli Lil­ly CEO David Ricks, who quick­ly inked a $960 mil­lion deal to buy CoLu­cid and a late-stage mi­graine drug a cou­ple of months ago, il­lus­trat­ing a re­turn to the deal ta­ble for a com­pa­ny that large­ly shunned bil­lion-dol­lar deals un­der John Lech­leit­er.

Oth­er new CEOs still look­ing to es­tab­lish their own M&A style in­clude Gilead CEO John Mil­li­gan and Bio­gen CEO Michel Vounatsos, both lead­ers of bio­phar­ma com­pa­nies that are all but be­ing or­dered by an­a­lysts to land a few big fish. Mark Alles, the new CEO at Cel­gene, has a dif­fer­ent kind of chal­lenge. Cel­gene set the in­dus­try’s fastest pace on drug deals un­der Ex­ec­u­tive Chair­man Bob Hug­in and now in­dus­try ob­servers will see if Alles and his pro BD team can keep up the same fre­net­ic pace.

There cer­tain­ly are risks to this game. Rel­a­tive­ly new Sanofi CEO Olivi­er Brandi­court is still work­ing on mak­ing a good first im­pres­sion at the deal ta­ble, with lit­tle suc­cess. Af­ter get­ting shoved aside on Medi­va­tion, Acte­lion open­ly dissed the com­pa­ny’s takeover at­tempt in ex­plain­ing why it went with the vet­er­ans at J&J. Next time around, Sanofi in­vestors will ex­pect to see suc­cess.

Em­ma Walm­s­ley, GSK

Next up: New Glax­o­SmithK­line CEO Em­ma Walm­s­ley, who gets the top job April 1, as gener­ic com­pe­ti­tion starts to re­al­ly kill the Ad­vair fran­chise. She faces her own unique set of ex­pec­ta­tions at a com­pa­ny with one of the least ex­cit­ing pipelines in Big Phar­ma.

Soon we’ll see if she will look to the deal ta­ble to ac­com­plish some­thing that An­drew Wit­ty was nev­er able to suc­ceed at; Cre­ate a slate of new block­buster drug fran­chis­es, out­side of the vac­cines are­na. If so, she’ll need a few bil­lion-dol­lar chips of her own.

The view from End­points News
Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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