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

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.