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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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