Pur­due Phar­ma pro­pos­es $12B set­tle­ment to clean up opi­oid mess — re­port

Af­ter months of ne­go­ti­a­tions with states and fed­er­al plain­tiffs ac­cus­ing it of in­sti­gat­ing the opi­oid cri­sis through ag­gres­sive and de­cep­tive mar­ket­ing tac­tics, Pur­due Phar­ma is ready to pay $10 to $12 bil­lion to set­tle it all.

Dan Pol­ster Fed­er­al Bar As­so­ci­a­tion

The po­ten­tial deal would cov­er hun­dreds of law­suits be­ing waged against the com­pa­ny by states, cities, towns and tribes, which is be­ing over­seen by Unit­ed States dis­trict judge Dan Pol­ster in Cleve­land, along­side cas­es in­volv­ing oth­er pre­scrip­tion opi­oid mak­ers. As part of the deal, the Sack­ler fam­i­ly — who had been charged with build­ing a “multi­bil­lion-dol­lar drug em­pire based on ad­dic­tion” — will give up own­er­ship in Pur­due.

The ma­jor­i­ty of the set­tle­ment will come in the form of in-kind drug do­na­tions and prof­its, with the ex­cep­tion of a $3 bil­lion cash pay­ment from the Sack­ler fam­i­ly ($4.5 bil­lion if they man­age to sell Mundiphar­ma, an­oth­er drug com­pa­ny they own, for more). Pur­due has re­port­ed­ly pledged to pro­vide more than $4 bil­lion in drugs, in­clud­ing mar­ket­ed and ex­per­i­men­tal treat­ments for opi­oid ad­dic­tion and over­dose re­ver­sals, to the pub­lic for free. Un­der a new pub­lic ben­e­fit trust struc­ture, all sales of its oth­er drugs — in­clud­ing Oxy­Con­tin, the opi­oid at the cen­ter of its mis­deeds — would al­so go to the plain­tiffs.

If the set­tle­ment is reached, Pur­due will set a re­struc­tur­ing plan in­to mo­tion by first de­clar­ing Chap­ter 11 bank­rupt­cy, then tran­si­tion in­to a trust made of court-ap­point­ed trustees, who will then se­lect a board of di­rec­tors to run the day-to-day op­er­a­tions.

“While Pur­due Phar­ma is pre­pared to de­fend it­self vig­or­ous­ly in the opi­oid lit­i­ga­tion, the com­pa­ny has made clear that it sees lit­tle good com­ing from years of waste­ful lit­i­ga­tion and ap­peals,” the com­pa­ny said in a state­ment to NBC News, which first re­port­ed the deal.

Pur­due Phar­ma — which has re­port­ed­ly made more than $35 bil­lion in Oxy­Con­tin sales — and the Sack­ler fam­i­ly have pre­vi­ous­ly de­nied the le­gal al­le­ga­tions against them.

It’s un­clear whether, or how many, plain­tiffs are on board with the pro­posed terms of the deal. Pur­due is fram­ing it as a take it or leave it deal, since they plan to file for bank­rupt­cy no mat­ter the out­come and the re­sult­ing amount that could go in­to a set­tle­ment would be low­er than cur­rent­ly of­fered, ac­cord­ing to NBC.

An­drew Pol­lis Case West­ern Re­serve

“(The deal is) very sig­nif­i­cant. Nev­er be­fore have we ever seen a mem­ber of a pri­vate in­dus­try of­fer so much mon­ey to try to deal with a pub­lic health cri­sis of this mag­ni­tude,” An­drew Pol­lis, a law pro­fes­sor at Case West­ern Re­serve Uni­ver­si­ty, told NBC.

Opi­oid-re­lat­ed over­dos­es have claimed al­most 400,000 lives from 1999 to 2017, ac­cord­ing to the CDC. Gov­ern­ment at­tor­neys have brought over 2,000 law­suits against opi­oid man­u­fac­tur­ers and dis­trib­u­tors, both seek­ing dam­ages and at­tempt­ing to hold ex­ec­u­tives be­hind the de­ci­sions to boost opi­oid sales at all costs ac­count­able.

In May, ex­ec­u­tives at In­sys — which mar­kets a po­tent fen­tanyl spray — were found guilty of en­gag­ing in a bribery scheme to get doc­tors to pre­scribe their drug, Sub­sys. The com­pa­ny had pre­vi­ous­ly agreed to pay $225 mil­lion to set­tle fed­er­al lit­i­ga­tions, but are still in set­tle­ment talks with states af­ter de­clar­ing bank­rupt­cy. And on Mon­day glob­al phar­ma con­glom­er­ate J&J was found guilty and fined $572 mil­lion in an Ok­la­homa court for its role in the opi­oid epi­dem­ic there.

The par­ties have un­til Fri­day to re­port back to Pol­ster on the deal, the dis­trict judge who had en­cour­aged the set­tle­ment talks, the Wash­ing­ton Post not­ed.

Elizabeth Nabel speaks at a news conference, Oct. 7, 2019 (Elise Amendola/AP Images)

Brigham and Wom­en's pres­i­dent Eliz­a­beth Nabel fol­lows Mon­cef Slaoui off Mod­er­na's board

Amid recent scrutiny on how Moderna’s top executives have been cashing out their increasingly valuable shares, the biotech is parting ways with a board member who’s also heading a hospital where its Covid-19 vaccine is being tested.

Elizabeth Nabel — the president of Brigham and Women’s Hospital — has followed in Moncef Slaoui’s footsteps in resigning from Moderna’s board of directors. She took the role in 2015, two years before the Operation Warp Speed leader did; and as with Slaoui and MIT professor Robert Langer, her term was due to expire in 2021.

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Tony Coles, Cerevel Therapeutics CEO

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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Roche de­clares a PhI­II fail­ure for Covid-19 as the IL-6 re­pur­pos­ing the­o­ry bites the dust

Another big IL-6 drug has failed to move the needle for Covid-19 patients, leaving that particular field of repurposed drug R&D on the ropes for the pandemic.

This morning it was Roche’s turn to outline a Phase III failure for Actemra, adding compelling data that have now all but extinguished the theory that an IL-6 drug could significantly help the most severely afflicted patients. That comes just weeks after Regeneron and Sanofi hit the red light on their trial for Kevzara after getting back-to-back readouts that made Roche’s trial a long shot at best.

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Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

UP­DAT­ED: Genen­tech slash­es near­ly 500 jobs in strate­gic shift to 'lo­cal health­care ecosys­tems.' Clin­i­cal spe­cial­ists make up the biggest group

Deep into the pandemic, the executives at Roche are executing an unusual plan to lay off nearly 500 workers at South San Francisco-based Genentech.

The huge Roche subsidiary handed in their WARN notice to the state a few days ago, noting that 474 staffers were being permanently cut from the payroll.

A spokesperson for the company told me via e-mail:

The majority of these roles are from our field organization and, though formally associated with our South San Francisco headquarters, are actually located throughout the United States. These position eliminations are not related to the COVID-19 pandemic, the clinical trials for which Actemra is being studied in COVID-19 pneumonia, or any specific therapeutic area.

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Robert Nelsen (Illustration by Emma Kumer for Endpoints News)

Af­ter Big Phar­ma aban­doned in­fec­tious dis­eases, 5 biotech con­trar­i­ans de­cid­ed to go all in. Then Covid-19 changed every­thing

Bob Nelsen had been quietly wondering how to eradicate viruses for years, before one day in 2015, he welcomed a pair of immunologists into the ARCH Venture Partners offices on the 34th floor of Seattle’s Wells Fargo Building.

Louis Picker and Klaus Früh, professors at Oregon Health & Science University, had by then spent 5 years running around the country in search of funding for their startup, TomegaVax, and Früh, at least, was nearing wit’s end. The Gates Foundation was interested but told them they needed other investors. Investors told them to come back with more data, pharmaceutical executives said they’re in the wrong game — too little money to be made fighting infectious disease. Still, a well-connected board member named Bob More landed them a meeting with the coveted venture capitalist, and so, in a narrow conference room overlooking the Puget Sound, Picker prepared to again explain the idea he had spent 15 years on: re-engineering a benign microbe into the first vaccines for HIV and better ones for hepatitis and tuberculosis.

“This lightbulb went on his head,” Picker recalled in a recent interview. “Most of them just didn’t get it. And Bob’s hit.”

By that point, Nelsen was more than just a venture capitalist. Scraggly and greying but no less opinionated at 52, he was mobbed at biotech conferences, having earned a reputation for crass wisdom and uncanny foresight, for making big bets on big ideas that changed medicine. Those ideas included DNA sequencing, which he first cut a check for in the 90s, and leveraging the immune system to tackle cancer. He earned millions making billion-dollar companies.

Yet for years he had harbored an almost singular obsession: “I hate viruses,” he told Forbes in 2016. He told me he was “pissed off” at them. The obsession drove him to his first biotech investment in 1993, for an inhalable flu vaccine approved a decade later and still in use. And it drove him to invest in CAR-T as a potential cure for HIV, years before it proved a wildly effective treatment for some cancers.

Now, listening to Picker talk about T cells and antibodies and the curious biology of cytomegalovirus, Nelsen began wondering if it was time for another bet. Picker’s technology was not only promising, he reasoned, it could be the basis of a company that changed how researchers approached viruses. Instead of trying to come up with an antidote for every pathogen, you could do what cancer researchers had learned to do, and harness the immune system to do the work for you.

This wasn’t a popular opinion at the time. “It’s like the least trendy idea in the world,” Nelsen told me. “People would say, ‘Why the hell are you going into infectious disease?’”

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Albert Bourla, Pfizer CEO (AP Images)

Mod­er­na, Pfiz­er be­gin to give glimpse of Covid-19 vac­cine pric­ing — and prof­its

What do you charge for a Covid-19 vaccine? The world is beginning to find out — and with it, just how much the vaccine developers stand to make.

Pfizer said that they are pricing one course of their vaccine at $39, confirming what their Operation Warp Speed contract last week had indicated. That contract, the first yet to a put a price on a potential coronavirus vaccine, paid Pfizer $1.95 billion for 100 million doses, or $19.5 per dose. With the vaccine coming in two doses per course, that’s $39.

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Sanofi and GSK say they're near a vac­cine deal with EU hours af­ter fi­nal­iz­ing Warp Speed con­tract

On the heels of landing the largest Warp Speed contract to date, Sanofi and GlaxoSmithKline continued to make moves Friday afternoon.

The two companies announced they are in advanced discussions with the EU to supply up to 300 million doses of their Covid-19 vaccine candidate, coming just a few hours after securing their $2.1 billion deal with the US. Should the agreement be finalized, all EU member states will have the option to purchase the vaccine.

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President Trump speaks during an event to sign executive orders on lowering drug prices, July 24, 2020 (Alex Brandon/AP Images)

Trump’s ‘rad­i­cal’, ‘hor­ri­ble’ ex­ec­u­tive or­ders on drug pric­ing earn a C-suite back­lash this week — with one threat to do more over­seas

Once the pandemic erupted in the US, Big Pharma enjoyed a brief period of detente — if not actually warm relations — with the Trump administration.

After years of criticizing high drug prices and threatening legislation that would curb the industry’s pricing freedom, the president warmly encouraged the industry’s commitment to a pell mell race to new vaccines and drugs to fight Covid-19 — often at speeds that would have been considered impossible back in January. And it raised the possibility that biopharma could finally find a way to achieve some kind of popularity after years of public toxicity.

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Paul Hudson, AP Images

Sanofi and GSK grab largest Warp Speed deal yet, se­cur­ing $2.1B for a vac­cine that might come next year

Sanofi and GlaxoSmithKline have become the latest members of Operation Warp Speed, landing a $2.1 billion contract to scale up manufacturing for a vaccine that is on track for completion next year. The deal secures the US 100 million doses, with an option for 500 million more.

It is the largest contract the White House has given yet in its hunt to make 300 million doses of a vaccine available to the US public by January, although Sanofi has not committed to supply vaccines by that time, potentially opening the door for other developers with longer development paths to gain funding. The cash will help Sanofi scale the vaccine, which combines their recombinant DNA technology with GSK’s immune-boosting adjuvant, to a billion doses next year.

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