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.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.