Sen­a­tors Wyden, Mur­ray launch No­var­tis probe: 'What Amer­i­ca has seen here rais­es the specter of cor­rup­tion'

US Sen­a­tor Ron Wyden (D-OR) has opened up an in­ves­ti­ga­tion of No­var­tis’ $1.2 mil­lion in pay­ments to Michael Co­hen, Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney.

In a let­ter dat­ed Fri­day, Wyden out­lined a se­ries of big busi­ness is­sues No­var­tis $NVS had in front of the fed­er­al gov­ern­ment since it arranged the con­tract and hand­ed over about $100,000 a month in 12 pay­ments end­ing in Feb­ru­ary. Now the sen­a­tor wants a de­tailed out­line of who at No­var­tis was re­spon­si­ble for set­ting up the re­la­tion­ship and a copy of all the in­ter­ac­tions the com­pa­ny had with him — in let­ters, emails or any oth­er form.

“What de­liv­er­ables was the com­pa­ny seek­ing to gain?” he asks in the let­ter, first post­ed by STAT.

And he’s not alone. On the same day, Sen­a­tor Pat­ty Mur­ray (D-WA) added to the De­moc­rats’ mes­sages di­rect­ed at No­var­tis.

“This arrange­ment rais­es se­ri­ous con­cerns about the length No­var­tis was will­ing to go in or­der to cur­ry fa­vor with this Ad­min­is­tra­tion, and per­haps more trou­bling­ly, what it ex­pect­ed or was promised in re­turn,” Mur­ray’s let­ter says, ac­cord­ing to a re­port from CNN.

Wyden writes:

Mr. Co­hen’s firm is not a health care pol­i­cy con­sul­tan­cy, nor is Mr. Co­hen a reg­is­tered lob­by­ist. He is the Pres­i­dent’s per­son­al at­tor­ney, and Es­sen­tial Con­sul­tants re­port­ed­ly claimed to be a re­al es­tate con­sult­ing com­pa­ny. More­over, the amount of mon­ey that No­var­tis paid Mr. Co­hen’s firm far ex­ceed­ed what it paid any of the reg­is­tered lob­by­ing firms it en­gaged dur­ing the first 15 months of the Trump ad­min­is­tra­tion. Lob­by­ing records main­tained by the Sec­re­tary of the Sen­ate show that No­var­tis paid 15 lob­by­ing firms a to­tal of $2.5 mil­lion dur­ing that pe­ri­od, and that no firm re­ceived more than $300,000. By com­par­i­son, No­var­tis rate of pay­ment Mr.Co­hen’s firm was equal to $300,000 every quar­ter for an en­tire year.

In an in­ter­view on CNN, Wyden bast­ed the deal with No­var­tis.

“What Amer­i­ca has seen here rais­es the specter of cor­rup­tion in the White House,” the sen­a­tor said Thurs­day, re­fer­ring to the deal as a cor­po­rate shake­down by a gov­ern­ment for sale. “I want to know what No­var­tis thought it was buy­ing for the $1.2 mil­lion.”

A spokesman for No­var­tis re­spond­ed to a query from End­points News, not­ing: “We an­tic­i­pat­ed this let­ter which we just re­ceived and plan to ful­ly co­op­er­ate.”

No­var­tis has mount­ed an en­er­getic de­fense of CEO Vas Narasimhan since the is­sue first came to light ear­li­er in the week. Ex­ec­u­tives have not­ed in a range of in­ter­views with Stat and NBC and CBS that it was Joe Jimenez, the CEO un­til the be­gin­ning of Feb­ru­ary, who was con­tact­ed by Co­hen and di­rect­ed com­pa­ny of­fi­cials to line up the re­la­tion­ship and start mak­ing pay­ments.

The in­sid­er told STAT:

With a new ad­min­is­tra­tion com­ing in, ba­si­cal­ly, all the tra­di­tion­al con­tacts dis­ap­peared and they were all new play­ers. We were try­ing to find an in­road in­to the ad­min­is­tra­tion. Co­hen promised ac­cess to not just Trump, but al­so the cir­cle around him. It was al­most as if we were hir­ing him as a lob­by­ist.

Jimenez has not re­spond­ed to sev­er­al at­tempts to reach him, and a com­pa­ny spokesper­son tells me they no longer have con­tact in­for­ma­tion.

Narasimhan has apol­o­gized to em­ploy­ees for get­ting caught in the po­lit­i­cal up­roar.

“We made a mis­take en­ter­ing in­to this en­gage­ment and as a con­se­quence are be­ing crit­i­cized by a world that ex­pects more from us,” Narasimhan wrote in a mes­sage to staffers. “Yes­ter­day was not a good day for No­var­tis.”

But Wyden wants more than apolo­gies. And the back­ground ex­pla­na­tion — fol­low­ing a rev­e­la­tion from Stormy Daniels’ at­tor­ney Michael Ave­nat­ti ty­ing pay­ments from No­var­tis, AT&T, and a Russ­ian oli­garch di­rect­ly to Co­hen — still leaves plen­ty of ques­tions for elect­ed of­fi­cials to probe in the months ahead.

No­var­tis has con­sid­er­able ex­plain­ing left to do. And that means Narasimhan’s hon­ey­moon pe­ri­od has been cut bru­tal­ly short.

Im­age: US sen­a­tor Ron Wyden on No­vem­ber 8th, 2016 af­ter win­ning re-elec­tion. 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.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

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.

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

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

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.

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.