Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

No­var­tis has reached an­oth­er large set­tle­ment to re­solve mis­con­duct al­le­ga­tions, agree­ing to pay more than $678 mil­lion to set­tle claims that it had spent hun­dreds of mil­lions of dol­lars on lav­ish din­ners, so-called speak­ing fees and ex­pen­sive al­co­hol “that were noth­ing more than bribes” to get doc­tors to pre­scribe No­var­tis med­ica­tions.

The top-shelf al­co­hol and lav­ish meals in­clud­ed a $3,250 per per­son night at Nobu in Dal­las, a $672-per per­son din­ner at Wash­ing­ton DC’s Smith & Wol­len­sky and a $314 per per­son meal at Sushi Roku in Pasade­na, ac­cord­ing to the Jus­tice De­part­ment com­plaint. There were at least 7 trips to Hoot­ers and fish­ing trips in Alas­ka and off the Flori­da coast. Each of these events were sup­posed to be “speak­er pro­grams” where doc­tors ed­u­cat­ed oth­er doc­tors on a drug, but the DOJ al­leged many were “bo­gus” wine-and-dine events where the drug was bare­ly men­tioned, if at all.  (“No­body pre­sent­ed slides on the fish­ing trips,” the com­plaint says.)

The civ­il suit, first filed by a No­var­tis whistle­blow­er in 2011 and joined by the Jus­tice De­part­ment two years lat­er, cov­ers com­pa­ny con­duct from 2002 to 2011. They large­ly cov­er car­dio­vas­cu­lar drugs, in­clud­ing Lotrel, Dio­van, Ex­forge, Tek­tur­na, Val­tur­na and Tekam­lo. A Jus­tice De­part­ment state­ment said that No­var­tis made “ex­ten­sive fac­tu­al ad­mis­sions” in the set­tle­ment.

“For more than a decade, No­var­tis spent hun­dreds of mil­lions of dol­lars on so-called speak­er pro­grams, in­clud­ing speak­ing fees, ex­or­bi­tant meals, and top-shelf al­co­hol that were noth­ing more than bribes to get doc­tors across the coun­try to pre­scribe No­var­tis’s drugs,” said act­ing US At­tor­ney Au­drey Strauss.

In a sec­ond set­tle­ment, No­var­tis agreed to pay $51.5 mil­lion to re­solve al­le­ga­tions it fun­neled mon­ey to cov­er pa­tients’ co-pays and il­le­gal­ly sub­si­dize the cost of its own high-priced drugs.

The res­o­lu­tions come as CEO Vas Narasimhan tries to dis­tance the com­pa­ny from its oc­ca­sion­al­ly un­sa­vory rep­u­ta­tion, say­ing in a state­ment to­day that they are “a dif­fer­ent com­pa­ny to­day” than they were dur­ing the pe­ri­od cov­ered by the law­suit. He added that they were mov­ing to­ward a dig­i­tal sys­tem that would large­ly move away from speak­ing pro­grams.

”To­day’s set­tle­ments are con­sis­tent with No­var­tis com­mit­ment to re­solve and learn from lega­cy com­pli­ance mat­ters,” Narasimhan said. “We are a dif­fer­ent com­pa­ny to­day — with new lead­er­ship, a stronger cul­ture, and a more com­pre­hen­sive com­mit­ment to ethics em­bed­ded at the heart of our com­pa­ny. I have been clear that I nev­er want us to achieve com­mer­cial suc­cess at the ex­pense of our val­ues — our val­ues must al­ways come first and are the foun­da­tion of every­thing we do. With these agree­ments we mark an im­por­tant mile­stone on our jour­ney to build trust with so­ci­ety as we con­tin­ue reimag­in­ing med­i­cine to im­prove and ex­tend lives all around the world.”

Yet this is not the first time that No­var­tis has promised re­form. Much of the com­plaint from to­day’s set­tle­ment cen­ters on the fact that the lav­ish din­ners took place while the Swiss phar­ma was han­dling a dif­fer­ent kick­backs law­suit and, in some in­stances, af­ter they had signed a Cor­po­rate In­tegri­ty Agree­ment. That law­suit was set­tled in 2010 for $442 mil­lion.

A week ago, No­var­tis paid $345 mil­lion to re­solve bribery charges re­lat­ed to ac­tions the com­pa­ny took in Greece, South Ko­rea and Viet­nam. And ear­li­er this year, they pled guilty and agreed to pay $195 mil­lion to charges that its gener­ics unit, San­doz, en­gaged in price fix­ing.

They’re not out of the woods yet. In June, 51 at­tor­neys gen­er­al sued a laun­dry list of gener­ics mak­ers for more price-fix­ing charges. San­doz was at the top of their list.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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FDA ap­proves GSK's BC­MA drug, mark­ing a rocky re­turn to can­cer for the British gi­ant

Despite concerns on both safety and efficacy, the FDA approved GlaxoSmithKline’s multiple myeloma drug belantamab mafodotin, deciding that for the sickest patients the benefits outweighed the risk.  It will be marketed as Blenrep and sold for $23,900 per month.

The approval is notable both for the multiple myeloma field and for GSK itself. It’s the first approval for a drug that targets BCMA, a protein overexpressed on multiple myeloma cells that researchers have been trying to target for over a decade. A flurry of other BCMA drugs, having already shown promise in early trials, are likely to follow in the next few years.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.