In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of law­suits tar­get­ing co­pay char­i­ty foun­da­tions, the DOJ has been hunt­ing drug­mak­er In­cyte for what pros­e­cu­tors al­leged was a kick­back scheme to court pa­tients. Now, In­cyte is clear­ing its name.

In­cyte will shell out $12.6 mil­lion to set­tle claims it fun­neled funds through a char­i­ty foun­da­tion to cov­er fed­er­al co­pays for pa­tients tak­ing its JAK in­hibitor Jakafi, the DOJ said this week.

Fed­er­al pros­e­cu­tors al­leged that In­cyte ac­tive­ly pushed for pa­tients who were not el­i­gi­ble for the foun­da­tion’s help to be in­clud­ed on its rolls, even work­ing to help those pa­tients ap­ply for aid through a con­trac­tor. The com­pa­ny “pres­sured the foun­da­tion, through phone calls and emails” to add pa­tients who were deemed in­el­i­gi­ble, the DOJ said.

It’s the lat­est set­tle­ment in a years-long crack­down on phar­ma char­i­ty foun­da­tions. The in­dus­try says those foun­da­tions are a mech­a­nism to help pa­tients who can­not cov­er their fed­er­al pro­gram co­pays to have ac­cess to key med­i­cines. Mean­while, the DOJ con­tends the pro­grams are just a dif­fer­ent form of pa­tient kick­backs. — Kyle Blanken­ship

US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

Now that just un­der half of Amer­i­cans have re­ceived at least one dose of a Covid-19 vac­cine, the US ap­par­ent­ly has an­oth­er vac­cine on its mind.

Paul Chap­lin

BAR­DA is ex­er­cis­ing a $12 mil­lion op­tion to pur­chase more dos­es of Bavar­i­an Nordic’s Jyn­neos vac­cine for small­pox and mon­key­pox, the com­pa­ny an­nounced on Fri­day. The op­tion is part of a $202 mil­lion or­der made last April for up to 1.4 mil­lion liq­uid-frozen dos­es.

“This year, we are launch­ing op­er­a­tions in our new­ly es­tab­lished fill and fin­ish plant, which en­ables us to bring the fi­nal step of com­mer­cial man­u­fac­tur­ing of JYN­NEOS in-house as the first prod­uct on the line, mark­ing a sig­nif­i­cant mile­stone in our long-stand­ing part­ner­ship with the U.S. gov­ern­ment,” CEO Paul Chap­lin said in a state­ment.

Mon­key­pox is a rare virus that’s pri­mar­i­ly na­tive to Africa near trop­i­cal rain­forests. It’s sim­i­lar to hu­man small­pox — caus­ing symp­toms “sim­i­lar to but milder than” the in­fec­tious dis­ease — and old­er small­pox vac­cines have been shown to have a high de­gree of suc­cess in pro­tect­ing hu­mans from mon­key­pox.

Jyn­neos was ap­proved by the FDA for pre­ven­tion of both mon­key­pox and small­pox back in 2019. It’s based on a live, at­ten­u­at­ed vac­cinia virus, which can’t be repli­cat­ed but is strong enough to in­duce an im­mune re­sponse. — Nicole De­Feud­is 

Drug reg­u­la­tors to phar­ma: Widen ac­cess to clin­i­cal tri­al da­ta

An in­ter­na­tion­al group of drug reg­u­la­tors, in­clud­ing the FDA, EMA and WHO, called on the phar­ma­ceu­ti­cal in­dus­try on Fri­day to be more proac­tive in shar­ing clin­i­cal da­ta for all new med­i­cines and vac­cines.

“Reg­u­la­tors con­tin­ue to spend con­sid­er­able re­sources ne­go­ti­at­ing trans­paren­cy with spon­sors. Both pos­i­tive and neg­a­tive clin­i­cal­ly rel­e­vant da­ta should be made avail­able, while on­ly per­son­al da­ta and in­di­vid­ual pa­tient da­ta should be redact­ed,” they said in a joint state­ment.

Echo­ing a sim­i­lar call from two law pro­fes­sors last month, the reg­u­la­tors al­so stressed that da­ta must be pub­lished when a reg­u­la­to­ry re­view is fi­nal­ized, es­pe­cial­ly if a drug is mar­ket­ed. The push comes as the FDA for the first time cracked down on a phar­ma com­pa­ny that failed to post da­ta for a failed tri­al to the US gov­ern­ment data­base for clin­i­cal tri­als.

“ICM­RA [In­ter­na­tion­al Coali­tion of Med­i­cines Reg­u­la­to­ry Au­thor­i­ties] and WHO call on the phar­ma­ceu­ti­cal in­dus­try to com­mit, with­in short time­lines, and with­out wait­ing for le­gal changes, to pro­vide vol­un­tary un­re­strict­ed ac­cess to tri­al re­sults da­ta for the ben­e­fit of pub­lic health,” they wrote. — Zachary Bren­nan

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Is­rael's VBL Ther­a­peu­tics hit with CMC de­lays in ovar­i­an can­cer study; No­vo Hold­ings buys out di­ag­nos­tics play­er BBI

VBL Therapeutics has hit a roadblock in its Phase III study for platinum-resistant ovarian cancer.

Batches of the VB-111 compound being evaluated in the study are still being reviewed by the FDA’s CMC group, the company announced Tuesday, with regulators trying to compare VB-111 manufacturing between different sites. As a result, supply will be limited and VBL is pausing enrollment of the 400-patient study until the batches can be cleared.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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