Sen­ate Dems blast No­var­tis’ ties to Trump at­tor­ney, claim phar­ma gi­ant of­fered mis­lead­ing ex­pla­na­tions in damn­ing re­port

Sen­ate De­moc­rats is­sued a damn­ing re­port Fri­day morn­ing say­ing that their probe of the $1.2 mil­lion in pay­ments No­var­tis made to Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen re­vealed that ex-CEO Joe Jimenez had ex­ten­sive con­tacts with Co­hen re­lat­ed to drug pol­i­cy and ac­cess to the White House, and that com­pa­ny of­fi­cials then went on to mis­lead the pub­lic re­cent­ly with their ex­pla­na­tion for what had hap­pened.

Joe Jimenez

The ex­plo­sive charges con­tend that rather than the brief and in­con­se­quen­tial con­tact No­var­tis claimed to have had with Co­hen, Jimenez was in con­tact with the at­tor­ney by phone on 4 oc­ca­sions, with mul­ti­ple email ex­changes over 6 months. The com­mu­ni­ca­tions in­clud­ed “the Trump ad­min­is­tra­tion’s drug pric­ing pro­pos­als, No­var­tis’s po­ten­tial in­vest­ment in a small drug com­pa­ny backed by Colum­bus No­va, and with re­gard to opi­oid law­suits.”

“What he was sell­ing was a line of ac­cess to the Trump ad­min­is­tra­tion,” said Sen. Ron Wyden in an in­ter­view with ABC News. “That would be how I would char­ac­ter­ize it.”

No­var­tis quick­ly kicked back at the Dems’ re­port this morn­ing, say­ing that they had co­op­er­at­ed ful­ly with the probe and that it dis­agreed with its con­clu­sion that the phar­ma gi­ant had of­fered mis­lead­ing com­ments.

This was No­var­tis’ de­fense last May, which the sen­a­tors say doesn’t stand up un­der ex­am­i­na­tion:

“Mr. Co­hen had made no ef­fort to learn any­thing about No­var­tis, or the pol­i­cy is­sues that were of con­cern to No­var­tis specif­i­cal­ly, or the phar­ma­ceu­ti­cal in­dus­try gen­er­al­ly…[he] was not able to pro­vide guid­ance as to how [the Trump ad­min­is­tra­tion] would eval­u­ate and re­spond to the rel­e­vant pol­i­cy is­sues. …[and] was not able to de­liv­er … sub­stan­tive con­sult­ing ad­vice and in­sight.”

Ac­cord­ing to the re­port, No­var­tis’ claim that it sus­pend­ed con­tact af­ter one meet­ing in ear­ly March is sim­ply not true, of­fer­ing re­peat­ed ex­am­ples of e-mail com­mu­ni­ca­tion be­tween Co­hen and Jimenez, as they dis­cussed in­vest­ments, pub­lished ar­ti­cles and pol­i­cy.

(C)on­trary to No­var­tis’s state­ment that it did not have fur­ther en­gage­ment with Mr. Co­hen, the doc­u­ments No­var­tis pro­vid­ed to the Sen­a­tors show that Mr. Co­hen main­tained reg­u­lar con­tact with Mr. Jimenez un­til at least Sep­tem­ber 2017.  No­var­tis’ cur­rent CEO Vas­ant Narasimhan nev­er com­mu­ni­cat­ed with Mr. Co­hen.

The re­port goes on to state that No­var­tis’ claim — made two months ago un­der Narasimhan — that the on­ly rea­son it con­tin­ued to pay Co­hen month­ly pay­ments for a year was that it was con­trac­tu­al­ly ob­lig­at­ed to do so al­so ap­pears to be un­true.

No­var­tis may have mis­led the pub­lic when the com­pa­ny stat­ed that it con­tin­ued to pay Mr. Co­hen the full $1.2 mil­lion even af­ter dis­cov­er­ing that he could not pro­vide the promised con­sult­ing ser­vices be­cause “the con­tract could not be ter­mi­nat­ed at will.” To the ex­tent this as­ser­tion is true, it is be­cause No­var­tis en­gaged in ex­ten­sive ne­go­ti­a­tions that re­sult­ed in weak­er and vaguer con­tract lan­guage than the com­pa­ny had ini­tial­ly sought. But the as­ser­tion does not ap­pear to be cor­rect. It ap­pears that in fact the com­pa­ny could have ter­mi­nat­ed Mr. Co­hen’s con­tract.

The damn­ing re­port al­so notes:

The ini­tial draft con­tract pro­pos­al that No­var­tis sent to Mr. Co­hen – which Mr. Co­hen lat­er mod­i­fied – called ex­plic­it­ly for him to pro­vide “ac­cess to key pol­i­cy­mak­ers” in the Trump ad­min­is­tra­tion, and he rep­re­sent­ed that he would do so. In June 2017, Mr. Jimenez sent Mr. Co­hen an email – “based on our con­ver­sa­tion last week” – trans­mit­ting a six-point plan con­tain­ing No­var­tis’s list of “ideas to low­er drug costs in the U.S.” which, ac­cord­ing to No­var­tis, was for “dis­cus­sion with Trump ad­min­is­tra­tion” of­fi­cials.

The plan in­clud­ed ini­tia­tives cham­pi­oned by the phar­ma­ceu­ti­cal in­dus­try.Mr. Co­hen stat­ed he would show the doc­u­ment to an uniden­ti­fied third par­ty linked to the ad­min­is­tra­tion, who would pro­vide feed­back on the doc­u­ment. Mr. Co­hen promised to pro­vide the third-par­ty feed­back to Mr. Jimenez.

Sev­er­al of the No­var­tis pro­pos­als would lat­er ap­pear in the ad­min­is­tra­tion’s drug pric­ing plan re­leased in May 2018.

An­drew In­trater runs Colum­bus No­va, which is linked to his cousin, Vik­tor Vek­sel­berg, a Russ­ian bil­lion­aire oli­garch with close ties to Russ­ian pres­i­dent Vladimir Putin. Ac­cord­ing to the re­port, Co­hen brought up an in­vest­ment op­por­tu­ni­ty in Yamo Phar­ma­ceu­ti­cals, which has ties to Colum­bus No­va, with Jimenez. States the re­port:

While No­var­tis had de­clined to in­vest in Yamo af­ter a pre­vi­ous meet­ing, Mr. Co­hen asked Mr. Jimenez to “check to see if it was han­dled prop­er­ly.” With­in an hour, Mr. Jimenez promised to over­see the is­sue  per­son­al­ly. Key Colum­bus No­va per­son­nel al­so serve as Yamo of­fi­cials, and Colum­bus  No­va pro­vid­ed “Back Of­fice & Fi­nance Ser­vices” to the phar­ma­ceu­ti­cal com­pa­ny.

The re­port was writ­ten by staff for Sen­a­tors Wyden, Pat­ty Mur­ray, Eliz­a­beth War­ren and Richard Blu­men­thal, who de­mand­ed more in­fo from No­var­tis af­ter the pay­ments were re­vealed in May.

Com­pa­ny ex­ecs knew back in No­vem­ber that they could face a pub­lic out­cry over the is­sue, 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.

No­var­tis quick­ly turned de­fen­sive once the pay­ments were re­vealed, trig­ger­ing a fire storm of con­tro­ver­sy. The com­pa­ny quick­ly leaked com­pa­ny mem­os from Narasimhan con­ced­ing that the com­pa­ny had made a mis­take and pledg­ing to do bet­ter in the fu­ture. But the com­pa­ny has nev­er of­fered an ex­pla­na­tion of what the new CEO knew about the Co­hen mat­ter and when he knew it.

No­var­tis quick­ly kicked back at the re­port, not­ing:

We dis­agree with the re­port’s con­clu­sion that we is­sued a mis­lead­ing pub­lic state­ment re­gard­ing the ex­tent of our en­gage­ment with Mr. Co­hen. As the doc­u­ments we pro­duced show, No­var­tis had one and on­ly meet­ing with Mr. Co­hen on March 1, 2017 and then con­clud­ed he was not able to pro­vide the sub­stan­tive con­sult­ing ad­vice and in­sight for which he was hired. We nev­er asked Mr. Co­hen to per­form any ser­vices on our be­half af­ter March 1, nor did he per­form any.

The on­ly ad­di­tion­al com­mu­ni­ca­tion we had be­yond the March 1 meet­ing was when Mr. Co­hen ini­ti­at­ed con­tact with our for­mer CEO, Mr. Jimenez, on a hand­ful of oc­ca­sions. On one of these oc­ca­sions, Mr. Co­hen asked Mr. Jimenez for ideas on how to low­er drug prices. In re­sponse, Mr. Jimenez pro­vid­ed him with a list of well-known ideas for low­er­ing the cost of phar­ma­ceu­ti­cals that had been dis­cussed pub­licly in the in­dus­try.

As we have al­ready ac­knowl­edged, No­var­tis made a mis­take in en­ter­ing in­to the con­tract with Michael Co­hen. And in hind­sight – and cer­tain­ly know­ing every­thing we know now – we should have tried to ter­mi­nate the con­tract with Mr. Co­hen re­gard­less of our views at the time of its le­gal en­force­abil­i­ty.”

Sen­ate De­moc­rats Re­port: White House Ac­cess for Sale by ar­salan arif on Scribd


Im­age: Michael Co­hen. SHUT­TER­STOCK

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,900+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.