Donald Trump, AP (Photo by: Dennis Van Tine/STAR MAX/IPx 2020)

As Trump touts his ‘great’ Covid drugs, the phar­ma cash flows to Biden, not him

Phar­ma­ceu­ti­cal gi­ants Re­gen­eron and Gilead Sci­ences got the kind of pub­lic­i­ty mon­ey can’t buy this week af­ter Pres­i­dent Don­ald Trump took their ex­per­i­men­tal drugs for his coro­n­avirus in­fec­tion, left the hos­pi­tal and pro­nounced him­self ful­ly re­cov­ered.

“It was, like, un­be­liev­able. I felt good im­me­di­ate­ly,” Trump said Wednes­day in a tweet­ed video. “I call that a cure.”

He praised Re­gen­eron’s mon­o­clon­al an­ti­body cock­tail, which mim­ics el­e­ments of the im­mune sys­tem, and men­tioned a sim­i­lar drug un­der in­ves­ti­ga­tion by Eli Lil­ly and Co. The pres­i­dent al­so took Gilead’s remde­sivir, an an­tivi­ral that has short­ened re­cov­ery times for Covid-19 pa­tients in ear­ly re­search.

There is no sci­en­tif­ic ev­i­dence that any of these drugs con­tributed to the pres­i­dent’s re­cov­ery, since many pa­tients do fine with­out them. It is al­so not known whether the pres­i­dent has been “cured,” since the White House has re­leased few specifics about the course of his ill­ness.

Yet as his cam­paign for re­elec­tion en­ters its fi­nal stretch, Trump is not feel­ing the love in cam­paign con­tri­bu­tions. Re­gen­eron, Gilead, Lil­ly and the in­dus­try as a whole are send­ing more mon­ey else­where.

Re­vers­ing a trend in which con­tri­bu­tions from drug­mak­ers’ po­lit­i­cal com­mit­tees and their em­ploy­ees have gone large­ly to Re­pub­li­can can­di­dates for pres­i­dent and Con­gress, so far for 2020 the in­dus­try has tilt­ed to­ward De­moc­rats.

The shift may re­flect in­dus­try ex­pec­ta­tions that De­mo­c­ra­t­ic pres­i­den­tial can­di­date Joe Biden will win, said Steven Bil­let, who teach­es cours­es in cor­po­rate lob­by­ing and po­lit­i­cal do­na­tions at George Wash­ing­ton Uni­ver­si­ty. Phar­ma com­pa­nies may see cam­paign largesse as lever­age if Biden fol­lows through on promis­es to ad­dress high drug prices, he said.

In a year when com­plaints about high pre­scrip­tion drug prices have been over­shad­owed by the pan­dem­ic, donors with ties to phar­ma man­u­fac­tur­ers have giv­en around $976,000 to Biden, ac­cord­ing to da­ta from the Cen­ter for Re­spon­sive Pol­i­tics. That’s near­ly three times the phar­ma con­tri­bu­tions to Trump, who re­cent­ly switched his tune from com­plain­ing about “rip-off” pre­scrip­tion prices to de­scrib­ing drug firms as “great com­pa­nies.”

“Tra­di­tion­al­ly the in­dus­try tends to fa­vor Re­pub­li­cans,” said Sarah Bryn­er, CRP’s re­search di­rec­tor. “But this cy­cle, we’re see­ing that flipped,” part­ly re­flect­ing De­moc­rats’ over­all greater suc­cess in fundrais­ing, she said.

Of $177,000 giv­en so far to 2020 fed­er­al can­di­dates by Re­gen­eron’s em­ploy­ees and po­lit­i­cal ac­tion com­mit­tee, four-fifths have gone to De­moc­rats, in­clud­ing $35,203 to Biden, ac­cord­ing to CRP.

Re­gen­eron CEO Leonard Schleifer, a bil­lion­aire who has known Trump for years and be­longs to the Trump Na­tion­al Golf Club Westch­ester in New York’s Westch­ester Coun­ty, has a long his­to­ry of giv­ing to De­moc­rats. He gave $5,400 to Hillary Clin­ton’s 2016 pres­i­den­tial run and $120,000 in 2018 to a po­lit­i­cal ac­tion com­mit­tee at­tempt­ing to flip the Sen­ate to De­mo­c­ra­t­ic con­trol.

Schleifer has made no reg­is­tered po­lit­i­cal do­na­tions since last year, when his con­tri­bu­tions went main­ly to his son, Adam Schleifer, a De­mo­c­rat run­ning for Con­gress who lost in a pri­ma­ry this sum­mer.

North Car­oli­na Sen. Thom Tillis, rep­re­sent­ing a state with a large biotech in­dus­try and run­ning for re­elec­tion in a tight race, has been the biggest Re­pub­li­can re­cip­i­ent of Re­gen­eron dol­lars for 2020 races, tal­ly­ing $5,526 so far.

“This is a com­pa­ny that looks as though they’ve al­ways been com­mit­ted to De­moc­rats,” said Bil­let, a for­mer AT&T lob­by­ist who teach­es PAC man­age­ment. “And my guess is they just have a De­mo­c­ra­t­ic cul­ture in this com­pa­ny.”

A spokesper­son for Re­gen­eron, which has ap­plied for emer­gency use au­tho­riza­tion to by­pass the Food and Drug Ad­min­is­tra­tion ap­proval process for its drug, de­clined to com­ment on cam­paign do­na­tions and said the com­pa­ny will con­tin­ue clin­i­cal tri­als.

The drug is ex­pect­ed to cost thou­sands of dol­lars per dose. “You’re go­ing to get them for free,” Trump said of the Covid-19 drugs he took. The gov­ern­ment has agreed to make ini­tial dos­es of Re­gen­eron’s an­ti­body treat­ment “avail­able to the Amer­i­can peo­ple at no cost,” the com­pa­ny says.

But de­tails of the con­tract, in­clud­ing the price, re­mained se­cret. In any event, if pa­tients get the drug at no di­rect cost, “it doesn’t mean they’re not pay­ing for it,” said James Love, di­rec­tor of Knowl­edge Ecol­o­gy In­ter­na­tion­al, a non­prof­it that works to ex­pand ac­cess to med­ical tech­nol­o­gy. “They’re just pay­ing for it through tax­es.”

The gov­ern­ment is giv­ing Re­gen­eron $450 mil­lion to make and sup­ply the an­ti­body cock­tail.

Donors with Gilead ties al­so lean left, giv­ing two-thirds of their rough­ly $284,000 in con­tri­bu­tions so far this cy­cle to De­mo­c­ra­t­ic can­di­dates for Con­gress and pres­i­dent, the CRP da­ta shows, in­clud­ing about $36,000 to Biden.

At Lil­ly, where Health and Hu­man Ser­vices Sec­re­tary Alex Azar once ran the U.S. di­vi­sion, 54% of the mon­ey has gone to De­moc­rats and 46% to Re­pub­li­cans. Lil­ly em­ploy­ees have giv­en $45,000 to Biden and $13,000 to Trump, ac­cord­ing to CRP.

Biden does not ac­cept do­na­tions from cor­po­rate PACs; all his Re­gen­eron, Lil­ly and Gilead dol­lars came from their em­ploy­ees.

Much of this year’s over­all phar­ma shift to De­moc­rats comes in the pres­i­den­tial race. KHN’s Phar­ma Cash to Con­gress da­ta track­ing sit­ting mem­bers still shows a pref­er­ence this cy­cle of phar­ma PACs tar­get­ing con­gres­sion­al Re­pub­li­cans, $6 mil­lion so far com­pared with $4.7 mil­lion giv­en to De­moc­rats.

“Joe Biden has Big Phar­ma — as well as Big Tech and big banks — in his pock­et be­cause he’s worked for them for near­ly 50 years, rather than the Amer­i­can peo­ple,” said Saman­tha Za­ger, a spokesper­son for the Trump cam­paign.

On the cam­paign trail, Biden has fo­cused large­ly on im­prov­ing health in­sur­ance. But he al­so pro­pos­es let­ting Medicare ne­go­ti­ate drug prices, ty­ing drug-price in­creas­es to in­fla­tion and al­low­ing pa­tients to buy im­port­ed phar­ma­ceu­ti­cals.

Biden “will fur­ther re­duce health care costs while ex­pand­ing cov­er­age, end prac­tices like sur­prise billing, low­er pre­mi­ums and stand up to abus­es of pow­er by pre­scrip­tion drug com­pa­nies,” said cam­paign spokesper­son Rose­mary Boeglin.

Be­fore Trump took of­fice, he said phar­ma com­pa­nies were “get­ting away with mur­der” over the prices they charge. De­spite the pres­i­dent’s claims and promis­es, he has done lit­tle to low­er pre­scrip­tion drug prices, ac­cord­ing to ex­perts and fact-check­ers.

A Trump ex­ec­u­tive or­der this month would re­quire Medicare to pay no more for drugs than oth­er de­vel­oped na­tions, but it starts with a test pro­gram and could take months or years to im­ple­ment.

Phar­ma com­pa­nies were among the biggest ben­e­fi­cia­ries of Trump’s 2017 tax cut, sav­ing bil­lions by be­ing able to bring home un­taxed for­eign cash and bil­lions more in low­er rates.

By Jay Han­cock (KHN da­ta ed­i­tor Eliz­a­beth Lu­cas con­tributed to this re­port.)

First pub­lished at KHN (Kaiser Health News) — a non­prof­it news ser­vice cov­er­ing health is­sues. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of KFF (Kaiser Fam­i­ly Foun­da­tion), which is not af­fil­i­at­ed with Kaiser Per­ma­nente.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

Covid-19 roundup: As­traZeneca could soon re­sume US vac­cine tri­als; Pfiz­er's dis­tri­b­u­tion plan in­volves spe­cial ship­ping box­es, no whole­salers 

AstraZeneca’s Covid-19 vaccine trial could resume in the US later this week, according to a Reuters report.

Experimental dosing of the candidate came screeching to a halt in September, when a participant in the UK suffered what’s believed to be the spinal inflammatory condition transverse myelitis. Trials have already resumed in the UK, Brazil, India, Japan and South Africa — and four anonymous sources told Reuters that a green light from the US could come as early as this week.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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