Michael Co­hen on No­var­tis ties: '(T)hey want­ed me to pro­vide ac­cess to gov­ern­ment, in­clud­ing the pres­i­den­t'

Michael Co­hen tes­ti­fy­ing in front of Con­gress (CSPAN).

Michael Co­hen isn’t just call­ing Pres­i­dent — and for­mer client — Don­ald Trump a liar and a con man. He’s al­so claim­ing that phar­ma gi­ant No­var­tis had tried to set him up as a lob­by­ist for the com­pa­ny in an at­tempt to gain di­rect ac­cess to Trump and oth­er in­flu­en­tial gov­ern­ment of­fi­cials.

And that’s a far cry from the way that No­var­tis ex­ecs have char­ac­ter­ized their mo­ti­va­tion be­hind the $1.2 mil­lion con­tract, which they main­tained con­sis­tent­ly was a straight­for­ward but short-lived at­tempt to gain in­sights in­to the Trump ad­min­is­tra­tion’s thoughts on health­care pol­i­cy.

“No­var­tis sent me their con­tract, which stat­ed specif­i­cal­ly that they want­ed me to lob­by,” Co­hen told law­mak­ers in to­day’s high pro­file tes­ti­mo­ny on Capi­tol Hill. “That they want­ed me to pro­vide ac­cess to gov­ern­ment, in­clud­ing the pres­i­dent.”

“That para­graph was crossed out by me, ini­tialed, and writ­ten in my own hand­writ­ing that says I will not lob­by or do gov­ern­ment re­la­tions work,” he con­tin­ued, ac­cord­ing to a tran­script of the re­marks pub­lished by Reuters. 

His re­marks came in re­sponse to ques­tions from Rep. Mark Mead­ows (R-NC), who want­ed to know more about Co­hen’s op­er­a­tions while he was still close to Trump. In the ex­change, Co­hen said he had di­rect­ly in­ter­act­ed with No­var­tis 6 times. And the dis­barred at­tor­ney con­test­ed No­var­tis’ po­si­tion — out­lined by com­pa­ny sources to var­i­ous me­dia out­lets at the time — that he had con­tact­ed the com­pa­ny. No­var­tis, he said, sought him out based “on my knowl­edge of the enig­ma” that Trump is.

Joe Jimenez

No­var­tis’ ex­pla­na­tion — echoed by the re­cent­ly re­tired CEO Joe Jimenez — was that their out­reach to the at­tor­ney was a sim­ple way to gain a bet­ter un­der­stand­ing of the Trump ad­min­is­tra­tion’s ap­proach to health­care poli­cies. Once it be­came ap­par­ent that he could pro­vide lit­tle help, they con­tin­ued, the con­nec­tion end­ed.

Then last year No­var­tis was shak­en to the core by a cor­po­rate cri­sis that erupt­ed around the news that their month­ly pay­ments to Co­hen went in­to the same ac­count that was used to pay off Stormy Daniels, the strip­per who claimed to have had an af­fair with Trump.

A few weeks af­ter the scan­dal broke last sum­mer, a group of De­moc­rats in the Sen­ate re­leased their own quick re­port, con­clud­ing that the com­pa­ny’s con­tention that top ex­ecs had on­ly a brief, in­con­se­quen­tial ex­change with Co­hen and were forced to pay out the con­tract mis­rep­re­sent­ed the nu­mer­ous con­tacts Jimenez had with Co­hen.

“What he was sell­ing was a line of ac­cess to the Trump ad­min­is­tra­tion,” said Sen. Ron Wyden in an in­ter­view with ABC News in Ju­ly. “That would be how I would char­ac­ter­ize it.” Wyden and his col­leagues out­lined nu­mer­ous con­tacts Jimenez had with Co­hen in his last year as CEO, be­fore Vas Narasimhan took the reins.

Vas Narasimhan

No­var­tis re­ject­ed that po­si­tion at the time and quick­ly shut­tered the win­dow on com­ments. It’s stay­ing shut to­day. A spokesper­son for the com­pa­ny told End­points News:

We have pre­vi­ous­ly ad­dressed all ques­tions re­gard­ing our re­la­tion­ship with Es­sen­tial Con­sul­tants and we con­sid­er this mat­ter closed.

CEO Narasimhan has sought to put as much dis­tance as pos­si­ble be­tween him­self and the Co­hen sto­ry, but the com­pa­ny’s ex­pla­na­tions all took part on his watch. In the wake of the news that No­var­tis had paid Co­hen $1.2 mil­lion, the phar­ma gi­ant — which has been in­volved in a string of ethics scan­dals over the years — vowed that it had turned a new leaf. Part of that ef­fort in­volved bring­ing in a promi­nent Ger­man at­tor­ney to lead their ethics, risk and com­pli­ance ef­forts. 

Im­age: Michael Co­hen (Shut­ter­stock)

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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