No­var­tis now says that it paid Trump's at­tor­ney $1.2M — and then throws ex-CEO Joe Jimenez un­der the bus

BioReg­num — The view from John Car­roll


John Car­roll, Ed­i­tor

With No­var­tis stuck square­ly in the mid­dle of a me­dia fren­zy cen­tered on pay­ments it made to a shell com­pa­ny con­trolled by Michael Co­hen, the per­son­al at­tor­ney for Pres­i­dent Don­ald Trump, the phar­ma gi­ant of­fered a few more de­tails Wednes­day about their re­la­tion­ship. It starts with an ad­mis­sion that No­var­tis ac­tu­al­ly paid Co­hen more than a mil­lion dol­lars, and it was fol­lowed by an ex­tra­or­di­nary pri­vate ad­mis­sion that then CEO Joe Jimenez was sold on the no­tion that Co­hen could pri­vate ac­cess to the ad­min­is­tra­tion.

In their new state­ment you can see in its en­tire­ty be­low, No­var­tis says it en­gaged with Co­hen in ear­ly 2017, agree­ing to pay the pres­i­dent’s at­tor­ney $100,000 a month for 12 months to pro­vide guid­ance on “health­care pol­i­cy mat­ters.” Af­ter their first meet­ing, No­var­tis said, the phar­ma gi­ant de­ter­mined that Co­hen “would be un­able to pro­vide the ser­vices that No­var­tis had an­tic­i­pat­ed,” and de­cid­ed to call a halt to any fu­ture meet­ings. The pay­ments, how­ev­er, had to con­tin­ue un­der the con­tract.

No­var­tis then ve­he­ment­ly de­nied a sug­ges­tion by Stormy Daniels’ at­tor­ney Michael Ave­nat­ti — who re­vealed a few of the $99,980 pay­ments from No­var­tis as well as more cor­po­rate con­tri­bu­tions and a $500,000 pay­out from Russ­ian oli­garch Vik­tor Vek­sel­berg — that the pay­ments could have been tied to a high-pro­file din­ner soon-to-be No­var­tis CEO Vas Narasimhan at­tend­ed in Davos with Trump at the end of Jan­u­ary. He wasn’t in­volved in any way, No­var­tis in­sists in­dig­nant­ly.

Sug­ges­tions to the con­trary clear­ly mis­rep­re­sent the facts and can on­ly be in­tend­ed to fur­ther per­son­al or po­lit­i­cal agen­das as to which No­var­tis should not be a part.

No­var­tis then re­peat­ed its as­ser­tion that it had been in con­tact with the spe­cial coun­sel’s of­fice un­der Robert Mueller and now con­sid­ers the mat­ter with the pres­i­dent’s chief fix­er closed.

But not quite.

Deeply em­bar­rassed at be­ing caught up in the Michael Co­hen/Stormy Daniels scan­dal, se­nior ex­ecs at No­var­tis fol­lowed up with some re­porters to throw Jimenez un­der the bus by ac­knowl­edg­ing that the com­pa­ny was pay­ing for ac­cess to the Trump ad­min­is­tra­tion, on the ex-CEO’s or­ders.

Co­hen “con­tact­ed us af­ter the new ad­min­is­tra­tion was in place,” the of­fi­cial told NBC News. “He was promis­ing ac­cess to the new ad­min­is­tra­tion.”

That’s old fash­ioned in­flu­ence ped­dling, if true.

Cit­ing a com­pa­ny in­sid­er, Stat News’ Ed Sil­ver­man re­ports that Co­hen reached out to Jimenez di­rect­ly, and that the CEO then di­rect­ed the com­pa­ny to make the deal. And even though the arrange­ment quick­ly de­railed, the com­pa­ny claims, Co­hen lat­er went back to new CEO Vas Narasimhan for a new deal, who re­ject­ed the over­ture.

The in­sid­er told Stat:

“With a new ad­min­is­tra­tion com­ing in, ba­si­cal­ly, all the tra­di­tion­al con­tacts dis­ap­peared and they were all new play­ers. We were try­ing to find an in­road in­to the ad­min­is­tra­tion. Co­hen promised ac­cess to not just Trump, but al­so the cir­cle around him. It was al­most as if we were hir­ing him as a lob­by­ist.”

That nar­ra­tive un­der­scores the com­pa­ny’s laser fo­cus on pro­tect­ing Narasimhan, at the ex­pense of Jimenez, who left at the be­gin­ning of Feb­ru­ary af­ter a long run at the top.

I’ve been try­ing to reach Jimenez di­rect­ly, but with­out suc­cess. A com­pa­ny spokesper­son told me he didn’t know how to con­tact the ex-CEO.

The Co­hen fi­as­co adds to No­var­tis’ grow­ing list of eth­i­cal woes, in­clud­ing is­sues with the way it re­ward­ed doc­tors in Chi­na. And it faces even big­ger ques­tions with its ap­proach to US pol­i­cy, which will be the sub­ject of a much an­tic­i­pat­ed speech by Trump on Fri­day.

You can ex­pect more ques­tions on No­var­tis’ role in the scan­dal af­ter that ap­pear­ance, par­tic­u­lar­ly if the ad­min­is­tra­tion goes easy on Big Phar­ma in try­ing to keep Trump’s re­peat­ed promise to “slash” drug prices.

Here’s the state­ment:

In Feb­ru­ary 2017, short­ly af­ter the elec­tion of Pres­i­dent Trump, No­var­tis en­tered in­to a one year agree­ment with Es­sen­tial Con­sul­tants.  With the re­cent change in ad­min­is­tra­tion, No­var­tis be­lieved that Michael Co­hen could ad­vise the com­pa­ny as to how the Trump ad­min­is­tra­tion might ap­proach cer­tain US health­care pol­i­cy mat­ters, in­clud­ing the Af­ford­able Care Act.   The agree­ment was for a term of one year, and paid Es­sen­tial Con­sul­tants 100,000 USD per month.  In March 2017, No­var­tis had its first meet­ing with Michael Co­hen un­der this agree­ment.  Fol­low­ing this ini­tial meet­ing, No­var­tis de­ter­mined that Michael Co­hen and Es­sen­tial Con­sul­tants would be un­able to pro­vide the ser­vices that No­var­tis had an­tic­i­pat­ed re­lat­ed to US health­care pol­i­cy mat­ters and the de­ci­sion was tak­en not to en­gage fur­ther.  As the con­tract un­for­tu­nate­ly could on­ly be ter­mi­nat­ed for cause, pay­ments con­tin­ued to be made un­til the con­tract ex­pired by its own terms in Feb­ru­ary 2018.

The en­gage­ment of Es­sen­tial Con­sul­tants pre­dat­ed Vas Narasimhan be­com­ing No­var­tis CEO and he was in no way in­volved with this agree­ment.  Con­trary to re­cent me­dia re­ports, this agree­ment was al­so in no way re­lat­ed to the group din­ner Dr. Narasimhan had at the World Eco­nom­ic Fo­rum in Davos with Pres­i­dent Trump and 15 Eu­rope based in­dus­try lead­ers.  Sug­ges­tions to the con­trary clear­ly mis­rep­re­sent the facts and can on­ly be in­tend­ed to fur­ther per­son­al or po­lit­i­cal agen­das as to which No­var­tis should not be a part.

In terms of the Spe­cial Coun­sel’s of­fice, No­var­tis was con­tact­ed in No­vem­ber 2017 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.

In a sec­ond big set­back for Covid-19 an­ti­body treat­ment hopes, Re­gen­eron halts en­roll­ment for more se­vere pa­tients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19.

The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen or mechanical ventilation in one of the trials on their antibody cocktail, after finding “a potential safety signal” and “an unfavorable risk/benefit profile.” The news comes a week after the NIH scrapped a trial of Eli Lilly’s Covid-19 antibody after finding it was having little effect on an initial cohort of hospitalized patients.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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As­traZeneca sells off heart fail­ure and hy­per­ten­sion drugs to Chep­lapharm for $400M

Out with the old and in with the new: AstraZeneca is selling off two heart failure and hypertension drugs to Germany-based Cheplapharm, bagging $400 million and making way for development in other areas.

Cheplapharm paid $200 million for the European rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil and hydrochlorothiazide) back in 2018. They’re now doubling that amount for commercial control in more than 70 countries.

News brief­ing: Ax­o­vant faces months of de­lay on lead Parkin­son's gene ther­a­py; Chi­nese CAR-T biotech nabs $100M

One of Axovant’s top gene therapy prospects for its second act is hitting a roadblock that could push its clinical timelines back by almost a year.

In an update, the biotech said it was informed about delays in CMC data and third-part fill-finish issues around mid-October by its manufacturing partner, Oxford Biomedica. Axovant has been developing a suspension-based process for the Parkinson’s drug; with that taking longer than expected, it now believes “it is unlikely that its planned randomized, sham-controlled trial of AXO-Lenti-PD will enroll patients by the end of calendar year 2021.”

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Covid-19 roundup: Flush with $486M con­tract, As­traZeneca signs Lon­za up to man­u­fac­ture an­ti­bod­ies; BioN­Tech's Ugur Sahin ex­pects vac­cine da­ta 'in a fort­night'

Days after scoring a $486 million BARDA contract to develop and manufacture its long-acting antibody combo for Covid-19, AstraZeneca has tapped Lonza to produce the drug substance at its mid-scale facility in Portsmouth, NH.

The drug, dubbed AZD7442, puts together two antibodies, first discovered by scientists at Vanderbilt University Medical Center, derived from convalescent patients who recovered from a SARS-CoV-2 infection. AstraZeneca licensed them in June and has since further engineered them with half-life extension and reduced Fc receptor binding.

CEO Kenji Yasukawa (Astellas)

In ear­ly blow to Ken­ji Ya­sukawa's R&D re­vamp, Astel­las drops out of the TIG­IT race, cit­ing PhI fail­ure

Just after AstraZeneca jumped into the TIGIT race, Astellas quietly disclosed that it was leaving, dropping out of a hunt for an immunotherapy approach that has shown tantalizing promise but remains largely unproven.

Astellas revealed in their second quarter earnings today that they’ve ended development of the anti-TIGIT antibody they acquired in their up to $400 million buyout of Potenza in 2018. The Japanese pharma had been testing it in combination with Keytruda in a 300-person Phase I study on patients with advanced solid tumors. A smaller study testing the antibody alone was completed, 2 years ahead of schedule, in July.

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Trou­bled Unum re­brands as Co­gent Bio­sciences, re­places CEO Chuck Wil­son with An­drew Rob­bins; Jen­nifer Fox ap­point­ed as CFO at David Hung-led Nu­va­tion Bio

→ Rife with turmoil and hit with a barrage of FDA holds as it spiraled into penny-stock territory, Unum Therapeutics hopes a new name — Cogent Biosciences — and a new CEO can turn its fortunes around. Andrew Robbins takes control now and succeeds Chuck Wilson, who founded Unum in 2014.

The cell therapy biotech stumbled out of the gate when it debuted on Nasdaq in 2018 and revealed that 2 of its 9 patients died in one arm of their ACTR087 trial. The FDA would hand down 3 different holds, two for ACTR087 and another for its experimental therapy ACTR707. Adding insult to injury, Unum shed around 60% of its workforce and jettisoned its old pipeline in favor of a new one a few months ago.

Two more biotechs price IPOs, bring­ing to­tal raise to record heights

Atea Pharmaceuticals and SQZ Biotechnologies have priced their public debuts, adding to this year’s record biotech IPO raise — a pot spilling over $13 billion that dwarfs the total raises of the last four years.

Last Friday, Nasdaq head of healthcare listings Jordan Saxe counted 72 biotech and biopharma IPOs this year, together raising $13.2 billion. He pegged a “fair estimate” of 75 debuts and just under $14 billion in proceeds to round out the year.