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

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

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In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

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Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

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Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

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Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

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The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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