No­var­tis sac­ri­fices its top at­tor­ney in an at­tempt to quell clam­or over $1.2M in Co­hen pay­ments — while ex-CEO Jimenez strug­gles to ex­plain

BioReg­num — The view from John Car­roll


Faced with a grow­ing cri­sis over its $1.2 mil­lion in pay­ments to Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis an­nounced ear­ly Wednes­day that the com­pa­ny’s top lawyer has abrupt­ly re­signed in hopes of bring­ing the whole tawdry af­fair to an end.

“Al­though the con­tract (with Co­hen) was legal­ly in or­der, it was an er­ror,” said Fe­lix Ehrat, group gen­er­al coun­sel of No­var­tis, in a state­ment. “As a co-sig­na­to­ry with our for­mer CEO, I take per­son­al re­spon­si­bil­i­ty to bring the pub­lic de­bate on this mat­ter to an end.”

The chances of that hap­pen­ing, though, are ze­ro. If any­thing, this move will on­ly height­en pres­sure on No­var­tis to ful­ly ex­plain why it agreed to pay $1.2 mil­lion to an at­tor­ney whose on­ly rel­e­vant at­trac­tion to the phar­ma gi­ant was his close per­son­al tie to the pres­i­dent. That re­mains the bot­tom line af­ter ex-CEO Joe Jimenez gave an in­ter­view to Forbes’ Matthew Her­p­er, where he strug­gled to ex­plain why the com­pa­ny hired Co­hen.

“If we were the ex­perts on pol­i­cy, he was the ex­pert on the way that they think, to­geth­er as a team it could be a way for us to bet­ter nav­i­gate what was go­ing to be a pret­ty sticky Af­ford­able Care Act Re­peal-and-Re­place,” Jimenez told Her­p­er in the in­ter­view.

Jimenez al­so took “full re­spon­si­bil­i­ty,” say­ing that his re­place­ment, Vas Narasimhan, was not in­volved. And he re­peat­ed­ly em­pha­sized the un­cer­tain­ty around Trump’s elec­tion for the move to gain some clar­i­ty.

“He was one of the very few num­ber of peo­ple who knew peo­ple in the ad­min­is­tra­tion,” Jimenez not­ed.

Ehrat’s sud­den ex­it — as well as the Jimenez in­ter­view — un­der­score how deeply the com­pa­ny has been bat­tered by the con­tro­ver­sy and the grow­ing list of ques­tions Narasimhan still faces. Com­pa­ny ex­ecs had pri­vate­ly been pin­ning the blame on Jimenez, who stepped down from the CEO’s job at the end of Jan­u­ary. Adding the gen­er­al coun­sel to the list of re­spon­si­ble play­ers — and send­ing him through the ex­its — does noth­ing to ad­dress the many ques­tions the com­pa­ny faces , while clum­sy at­tempts to apol­o­gize and re­fo­cus on the busi­ness un­der­score its in­abil­i­ty to man­age events.

The 41-year-old Narasimhan — who has nev­er ex­plained when he first heard about the Co­hen deal — is still fac­ing a drum­beat of omi­nous news.

We now hear that Switzer­land’s Of­fice of the At­tor­ney Gen­er­al has been dis­cussing the pos­si­bil­i­ty of launch­ing their own probe in­to the pay­ments, though the of­fi­cials there say that no for­mal probe is now un­der­way. And two promi­nent De­mo­c­ra­t­ic sen­a­tors, Eliz­a­beth War­ren and Richard Blu­men­thal, joined Ron Wyden and Pat­ty Mur­ray in scold­ing the com­pa­ny and ask­ing some point­ed ques­tions about ex­act­ly why it paid Co­hen that much and what it got in re­turn.

“Giv­en these on­go­ing mat­ters, the un­usu­al se­ries of pay­ments.by No­var­tis to the Pres­i­dent’s per­son­al at­tor­ney raise ob­vi­ous ques­tions about cor­rup­tion and whether No­var­tis and the Trump Ad­min­is­tra­tion were en­gaged in a pay-for-play op­er­a­tion,” War­ren and Blu­men­thal wrote, ahead of their list of queries.

Joe Jimenez

While the din of dis­ap­proval rose around the Basel head­quar­ters, Narasimhan him­self re­port­ed­ly took to the phone to tell thou­sands of the com­pa­ny’s man­agers that No­var­tis needs to clean up its act. Ac­cord­ing to a re­port from Bloomberg, Narasimhan told his man­agers by phone that the com­pa­ny had to move to re­think its re­la­tion­ship with lob­by­ists and re­gain the pub­lic’s trust.

Com­pa­ny ex­ecs knew back in No­vem­ber that they could face a hue and cry, when Robert Mueller’s team came in to ask ques­tions about the re­la­tion­ship. Co­hen him­self has been at the cen­ter of a me­dia cir­cus sur­round­ing the rev­e­la­tion that he had paid porn star Stormy Daniels $130,000 to keep qui­et about an al­leged af­fair with Trump — writ­ing a check from the same shell com­pa­ny that No­var­tis paid in­to. But No­var­tis nev­er dis­closed any­thing about the fed­er­al in­ves­ti­ga­tion in pub­lic fil­ings.

Ex­act­ly how Narasimhan plans to re­spond while re­main­ing hun­kered down in­side the com­pa­ny’s walls, though, re­mains to be seen. Does the CEO — now stout­ly de­fend­ed by a pha­lanx of me­dia con­tacts who in­sist the com­pa­ny will co­op­er­ate with all in­ves­ti­ga­tions — sub­mit to a Q&A with a friend­ly or per­haps high­ly rep­utable me­dia out­let? Does he start to pub­licly ad­dress the per­sis­tent ques­tions sur­round­ing No­var­tis pay­ments? Does some­one else get the ax?

No­var­tis rec­og­nizes it faces a cri­sis. But for now, there’s still no clear plan to deal with it in any kind of pub­lic way.


Im­age: Vas Narasimhan. GET­TY IM­AGES

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.