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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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