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.

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.