Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Bio­gen’s ad­u­canum­ab isn’t con­tro­ver­sial enough, the re­searchers at drug pric­ing watch­dog ICER have drawn up the con­tours of a new de­bate: If the ther­a­py does get ap­proved for Alzheimer’s by June, what price should it com­mand?

Their an­swer: At most $8,290 per year — and per­haps as lit­tle as $2,560.

Bri­an Abra­hams

Even at the top of the range, the pro­posed price is a frac­tion of the $50,000 that Wall Street has re­port­ed­ly come to ex­pect (al­though RBC an­a­lyst Bri­an Abra­hams puts the con­sen­sus fig­ure at $11.5K). With crit­ics, in­clud­ing ex­perts on the FDA’s ad­vi­so­ry com­mit­tee, mak­ing their fierce op­po­si­tion to ad­u­canum­ab’s ap­proval loud and clear, the pric­ing pres­sure adds one ex­tra wrin­kle Bio­gen CEO Michel Vounatsos doesn’t need as he or­ders full-steam prepa­ra­tion for a launch.

For RBC an­a­lyst Bri­an Abra­hams, the re­port is less an in­di­ca­tion of how ad­u­canum­ab would be priced — Bio­gen has said that its price is al­ready locked in, and drug­mak­ers of­ten charge high­er than ICER rec­om­men­da­tions — than fur­ther crit­i­cism on how the avail­able clin­i­cal da­ta are “in­suf­fi­cient” to de­ter­mine a ben­e­fit.

“Re­gard­less, we could see this hint at the po­ten­tial for low­er than cur­rent­ly an­tic­i­pat­ed pric­ing pow­er, which may not be ful­ly ap­pre­ci­at­ed giv­en lim­it­ed po­ten­tial ben­e­fits and sub­stan­tial an­cil­lary costs (such as screen­ing, mon­i­tor­ing, and ad­min­is­tra­tion),” he wrote, adding that la­bel re­stric­tions could al­so un­der­mine po­ten­tial rev­enue.

ICER based its as­sess­ment on Phase III re­sults that have al­ready been thor­ough­ly dis­closed and de­bat­ed by every­one from FDA in­sid­ers to ad­comm pan­elists to out­side sci­en­tists. The two stud­ies, which had iden­ti­cal de­signs, were ter­mi­nat­ed and thought to spell doom for ad­u­canum­ab un­til Bio­gen re­versed it­self and said one of them, dubbed EN­GAGE, ac­tu­al­ly yield­ed pos­i­tive da­ta when you an­a­lyze it prop­er­ly (the oth­er, EMERGE, re­mained neg­a­tive).

Bio­gen’s the­o­ry was that the dif­fer­ence had to do with pa­tient char­ac­ter­is­tics and ex­po­sure to full-dose ther­a­py.

While that is pos­si­ble, ICER not­ed, “oth­er ex­pla­na­tions are equal­ly or more like­ly.”

From the ex­ec­u­tive sum­ma­ry:

The post-hoc analy­ses do not con­sis­tent­ly ex­plain what was seen in the low- and high-dose arms of the tri­als, and one al­ter­na­tive ex­pla­na­tion is that the dif­fer­ences be­tween the tri­als are due to chance. Fur­ther­more, there is dis­agree­ment about whether the de­gree of im­prove­ment seen in EMERGE is clin­i­cal­ly im­por­tant, and the re­la­tion­ship be­tween clear­ance of be­ta-amy­loid in the brain and clin­i­cal im­prove­ment has yet to be con­clu­sive­ly demon­strat­ed, with neg­a­tive re­sults from more than 20 oth­er tri­als of an­ti-amy­loid drugs.

David Rind

On the oth­er side of the bal­ance lies cer­tain ev­i­dence that some pa­tients re­ceiv­ing the an­ti­body de­vel­oped se­vere cas­es of amy­loid-re­lat­ed imag­ing ab­nor­mal­i­ties, in­clud­ing bleed­ing in­to brain tis­sue, that led to dis­con­tin­u­a­tions.

Those are “im­por­tant ram­i­fi­ca­tions” along­side bud­getary con­cerns, ICER CMO David Rind said in a state­ment, that shouldn’t be ig­nored just be­cause of a dread­ful void of treat­ments for Alzheimer’s. Ul­ti­mate­ly, more da­ta are need­ed to prove ad­u­canum­ab’s worth.

It’s not a new ar­gu­ment. But it’s a promi­nent one in an in­creas­ing­ly high-stakes show­down as the clock ticks on an FDA de­ci­sion.

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).

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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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.”

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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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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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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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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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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