J&J gets a $30B Acte­lion buy­out and a new part­ner as Clozel’s team spins out with the pipeline

One of the big hur­dles fac­ing any­one who want­ed to buy Acte­lion was find­ing a way to come up with an ac­cept­able ac­qui­si­tion val­ue for its pipeline, which was high­ly prized by its in­de­pen­dent-mind­ed man­age­ment. So in the end, J&J got a buy­out deal done by be­ing cre­ative, spin­ning out a big part of the pipeline, with Acte­lion’s team in charge, while grab­bing rights to some prized late-stage as­sets for it­self.

In a deal an­nounced ear­ly this morn­ing, J&J agreed to pay $30 bil­lion for Acte­lion, ac­quir­ing an im­pres­sive port­fo­lio that in­cludes its block­buster new flag­ship ther­a­py for pul­monary ar­te­r­i­al hy­per­ten­sion. But they’re spin­ning its dis­cov­ery and ear­ly-stage ex­per­i­men­tal drugs in­to a new com­pa­ny — tem­porar­i­ly named R&D New­Co — while keep­ing a mi­nor­i­ty stake in the busi­ness.

Acte­lion CEO Jean-Paul Clozel will stay at the helm of the spin­out, while chair­man Jean-Pierre Gar­nier al­so re­tains his ti­tle in the new ven­ture.

J&J is pay­ing $280 a share in cash for the Swiss biotech and leav­ing R&D New­Co with a bil­lion dol­lars in liq­uid­i­ty as it lists on the Swiss ex­change. Acte­lion’s share­hold­ers are gain­ing shares in the new com­pa­ny as a div­i­dend. In ad­di­tion to a slate of mar­ket­ed drugs that in­cludes Op­sum­it, Up­travi and the orig­i­nal, pi­o­neer­ing PAH drug Tr­a­cleer, J&J al­so gains glob­al rights to pones­i­mod, an S1P1 re­cep­tor mod­u­la­tor in Phase III de­vel­op­ment for mul­ti­ple scle­ro­sis, along with cada­zol­id, a late-stage an­tibi­ot­ic in de­vel­op­ment for Clostrid­i­um dif­fi­cile-as­so­ci­at­ed di­ar­rhea.

J&J’s Alex Gorsky

J&J al­so gains an op­tion on the Phase II drug ACT-132577 for re­sis­tant hy­per­ten­sion. And the phar­ma gi­ant keeps a 16% stake in its spin­out, with a chance to dou­ble that amount through a con­vert­ible note.

The deal un­der­scores the high pre­mi­um that sought-af­ter drug as­sets can com­mand in this sell­er’s mar­ket. J&J is pay­ing 21 times es­ti­mat­ed 2020 earn­ings per share for the com­pa­ny, ac­cord­ing to Bloomberg’s Sam Fazeli, a very steep price for a deal like this. It al­so high­lights yet again how in­ef­fec­tive Sanofi has been in find­ing a ma­jor deal to help re­struc­ture the com­pa­ny as its di­a­betes fran­chise wanes. J&J es­sen­tial­ly el­bowed Sanofi aside, just as Pfiz­er did with Medi­va­tion.

J&J’s Alex Gorsky had this to say about the deal:

Adding Acte­lion’s port­fo­lio to our al­ready strong Janssen Phar­ma­ceu­ti­cals busi­ness is a unique op­por­tu­ni­ty for us to ex­pand our port­fo­lio with lead­ing, dif­fer­en­ti­at­ed in-mar­ket med­i­cines and promis­ing late-stage prod­ucts. We ex­pect to lever­age our es­tab­lished glob­al pres­ence and com­mer­cial strength to ac­cel­er­ate growth and pa­tient ac­cess to these im­por­tant ther­a­pies. Fur­ther, we be­lieve R&D New­Co will be strong­ly po­si­tioned to con­tin­ue Acte­lion’s lega­cy of in­no­va­tion and look for­ward to col­lab­o­rat­ing on the de­vel­op­ment of cut­ting-edge new ther­a­pies.

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.

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

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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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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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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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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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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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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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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