Stormy Daniels’ lawyer: No­var­tis made $400K in 'sus­pi­cious' pay­ments to Trump at­tor­ney Michael Co­hen

Stormy Daniels’ at­tor­ney Michael Ave­nat­ti has out­lined a se­ries of “sus­pi­cious fi­nan­cial trans­ac­tions” in­volv­ing close to $400,000 in pay­ments No­var­tis made to the ac­count of Es­sen­tial Con­sul­tants, which was ear­li­er used by Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen to pay $130,000 to the adult film ac­tress to keep her silent about al­le­ga­tions of an af­fair with the pres­i­dent.

Ac­cord­ing to the re­port, No­var­tis $NVS made four wire pay­ments of $99,980 each, just un­der the $100,000 mark, which Ave­nat­ti not­ed be­gan last fall and were wrapped in ear­ly Jan­u­ary of this year, just weeks be­fore soon-to-be CEO Vas Narasimhan met with Trump in Davos. [This sto­ry has been up­dat­ed with new in­for­ma­tion here: No­var­tis now says that it paid Co­hen’s com­pa­ny $1.2M]

A spokesper­son for No­var­tis re­spond­ed to a query I sent Tues­day night, say­ing: “Still chas­ing af­ter this – but want to clar­i­fy for your in­for­ma­tion that any agree­ments with Es­sen­tial Con­sul­tants were en­tered be­fore our cur­rent CEO tak­ing of­fice in Feb­ru­ary of this year and have ex­pired.” Lat­er, the phar­ma gi­ant tried to put some ad­di­tion­al dis­tance be­tween Narasimhan and the pay­ments, which they said in­volved “health­care pol­i­cy mat­ters.”

Who­ev­er drove the deal at No­var­tis, get­ting swept up in the Daniels scan­dal at the height of the me­dia tem­pest — days ahead of a ma­jor pol­i­cy ini­tia­tive on drug pric­ing by Trump — is ex­tra­or­di­nar­i­ly em­bar­rass­ing for the Swiss com­pa­ny, which still has plen­ty of ex­plain­ing to do.

The bomb­shell in the re­port spot­light­ed $500,000 paid by Russ­ian oli­garch Vik­tor Vek­sel­berg, with close ties to Rus­sia’s au­thor­i­tar­i­an leader Vladimir Putin, af­ter the elec­tion. Ac­cord­ing to Ave­nat­ti, that mon­ey could have been used to re­pay Co­hen for the hush mon­ey he paid Daniels. An­oth­er $200,000 came from AT&T, which has con­firmed the pay­ments to re­porters cov­er­ing the sto­ry, say­ing it paid for “in­sights in­to un­der­stand­ing the new ad­min­is­tra­tion.” Ko­rea Aero­space In­dus­tries paid $150,000.

“Mr.  Vek­sel­berg  and  his  cousin  Mr.  An­drew  In­trater  rout­ed  eight  pay­ments  to  Mr.  Co­hen  through  a  com­pa­ny  named  Colum­bus  No­va  LLC  (“Colum­bus”)  be­gin­ning  in  Jan­u­ary  2017  and  con­tin­u­ing  un­til  at  least  Au­gust  2017,” states Ave­nat­ti’s re­port.

“Al­so  in­clud­ed  in  these  sus­pi­cious  fi­nan­cial  trans­ac­tions  are  four  pay­ments  in  late  2017  and  ear­ly  2018  to­tal­ing  $399,920  made  by  glob­al  phar­ma­ceu­ti­cal  gi­ant  No­var­tis  di­rect­ly  to  Es­sen­tial  in  four  sep­a­rate  trans­ac­tions  of  $99,980  each  (just  be­low  $100,000).

“Fol­low­ing  these  pay­ments,  re­ports  sur­faced  that  Mr.  Trump  took  a din­ner  meet­ing  with the  in­com­ing  CEO  of  No­var­tis be­fore  Mr.  Trump’s  speech at  the  World  Eco­nom­ic  Fo­rum  in  Davos,  Switzer­land  in  late  Jan­u­ary  2018.”

Ave­nat­ti in­clud­ed a link to a Fier­cePhar­ma sto­ry on the group of ex­ec­u­tives meet­ing with Trump for din­ner in Davos.

Overnight, No­var­tis ex­ecs scram­bled to cir­cle the wag­ons around their CEO, con­firm­ing the pay­ments but in­sist­ing Narasimhan was nev­er in­volved in the “arrange­ment.” Their state­ment:

In Feb­ru­ary 2017, No­var­tis en­tered in­to a one year agree­ment with Es­sen­tial Con­sul­tants short­ly af­ter the elec­tion of Pres­i­dent Trump fo­cused on US health­care pol­i­cy mat­ters. The terms were con­sis­tent with the mar­ket. The agree­ment ex­pired in Feb­ru­ary 2018.

As al­ready stat­ed, the en­gage­ment of Es­sen­tial Con­sul­tants pre­dat­ed Vas Narasimhan be­com­ing No­var­tis CEO. Dr. Narasimhan had no in­volve­ment what­so­ev­er with this arrange­ment.

No­var­tis was con­tact­ed in No­vem­ber 2017 by lawyers from the Spe­cial Coun­sel’s of­fice re­gard­ing the com­pa­ny’s agree­ment with Es­sen­tial Con­sul­tants. No­var­tis co­op­er­at­ed ful­ly with the Spe­cial Coun­sel’s of­fice and pro­vid­ed all the in­for­ma­tion re­quest­ed. No­var­tis con­sid­ers this mat­ter closed as to it­self and is not aware of any out­stand­ing ques­tions re­gard­ing the agree­ment.

Vas Narasimhan may have been still the in­com­ing CEO at No­var­tis at that point in late Jan­u­ary, but he had di­rect­ed the de­vel­op­ment ef­fort at the phar­ma gi­ant for sev­er­al years and had been tapped for the CEO’s job months be­fore his meet­ing with Trump, along with a large group of ex­ec­u­tives. He took the CEO job at the be­gin­ning of Feb­ru­ary as CEO Joe Jimenez stepped down.

This al­so isn’t No­var­tis’ first in­volve­ment in a cor­rup­tion in­ves­ti­ga­tion. A lit­tle more than a month ago the com­pa­ny agreed to pay a fine of $25 mil­lion to the SEC af­ter com­pa­ny reps were ac­cused of of­fer­ing doc­tors in Chi­na lav­ish en­ter­tain­ment in ex­change for boost­ing the use of No­var­tis’ drugs.

No­var­tis and the phar­ma in­dus­try in gen­er­al have been step­ping up their pres­ence in Wash­ing­ton DC, in­ten­si­fy­ing lob­by­ing ef­forts as Trump and his top of­fi­cials in health­care fo­cus on a pledge to dra­mat­i­cal­ly low­er drug prices in the US. Trump is ex­pect­ed to give a speech on that very top­ic this Fri­day. I fol­lowed up with some more ques­tions for No­var­tis, but haven’t heard back.

Ave­nat­ti, mean­while, took to Twit­ter to call out all the com­pa­nies in­volved in con­tribut­ing to a “slush fund.”

https://twit­ter.com/MichaelAve­nat­ti/sta­tus/994156631440216069

Im­age: Michael Ave­nat­ti Shut­ter­stock

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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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

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As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

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Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

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The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? Ac­tu­al­ly, An­nex­on was al­ready prepped and primed to toss its S-1 to Wall Street as in­vestors ral­lied

The Wall Street IPO shuffle generally calls for a little distance between the crossover ante and the Wall Street double, but with the window on the street wide open and biotech sizzling hot, who’s waiting?

The crew at Annexon didn’t leave anyone in suspense for long about their IPO plans. A day after the Bay Area biotech with clinical plans to target neurodegeneration quietly unveiled a $100 million raise, they were back with an S-1 outlining a pitch to double that — or more.

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Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Sec­ond PhI­II study for Idor­si­a's sleep drug re­turns pos­i­tive re­sults, but al­so rais­es new ques­tions

Following a successful Phase III study in April showcasing the safety and potential of its new sleep drug, Idorsia posted some mixed news in the second Phase III study, but that won’t stop a planned filing aimed at regulatory approval.

The drug, a dual orexin receptor antagonist (DORA) called daridorexant, was found to significantly improve sleep maintenance and subjective total sleep time in 25 mg doses, replicating results from the first Phase III study. However, improvements in sleep onset and daytime functioning narrowly missed statistical significance, despite numerical consistency with the April study.

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Pfizer’s VC arm is heading up a $15 million round, announced Monday morning, and increasing its overall stake in Mission. Pfizer is also entering into a licensing agreement that would give it first dibs at negotiating exclusivity after accessing certain DUB inhibitors and screening them for their potential as drugs.