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

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

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Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

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More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.