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)

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine -- and spreads the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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That $335M JV Bay­er set up on CRISPR/Cas9? They’re let­ting the biotech part­ner car­ry on

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

Drug com­pa­nies reach $260M set­tle­ment just ahead of opi­oid tri­al; Oys­ter Point set terms for $85M IPO

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.

GSK of­floads two vac­cines in $1.1B deal as it works to re­vive the pipeline

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

Pfiz­er gets some en­cour­ag­ing PhI­II news on a fran­chise sav­ior, but is a dos­ing ad­van­tage worth the $295M up­front?

Close to 3 years after Opko tried to defend itself as shares tumbled on the news that its long-acting growth hormone had failed to outperform a placebo, the Pfizer partner $PFE is back. And this time they’re pitching Phase III data that demonstrate their drug is non-inferior — or maybe a tad better — than their well-known but fading standard in the field.
The comparator drug here is Genotropin, which earned a marginal $142 million for Pfizer last year — down 9% from the year before. Approved 24 years ago, biosimilars are now in development that Pfizer would like to stay out in front of. The market leader here is Norditropin, a growth hormone from Novo Nordisk that uses the same basic ingredient as Genotropin, which the Danish company sells with a kid-friendly self-injectable pen. That would also present some big competition if the new therapy from Opko/Pfizer makes it to the market.
The new data, says researchers, underscore that a weekly injection of somatrogon performed as well or slightly better than Genotropin (somatropin) in young children with growth hormone deficiency. Investigators tracked height velocity at 10.12 cm/year, edging out the older drug’s 9.78 cm/year. That 0.33 difference may not prove compelling to payers, though, who have been known to overlook dosing advantages in favor of lower costs.
That message may have weighed on the stock reaction this morning, with a 30%-plus hike $OPK giving way to more marginal gains.
Back in late 2016, Opko had to defend itself against a devastating Phase III setback as their initial late-stage trial failed against a sugar pill. Opko later blamed that setback on outliers in the study, though it wasn’t able to expunge the failure.

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