In a win for in­dus­try, Trump ad­min­is­tra­tion is­sues scathing re­view of Pelosi drug pric­ing bill

Pres­i­dent Don­ald Trump wants it both ways — cheap­er drugs and vig­or­ous in­no­va­tion. Ear­li­er this year, the De­moc­rats’ re­vealed their drug pric­ing bill, which is en­gi­neered to em­pow­er the HHS to ne­go­ti­ate prices for se­lect drugs. The White House has now emerged as one of its harsh­est crit­ics.

“Heavy-hand­ed gov­ern­ment in­ter­ven­tion may re­duce drug prices in the short term, but these sav­ings are not worth the long-term cost of Amer­i­can pa­tients los­ing ac­cess to new life­sav­ing treat­ments,” the Trump ad­min­is­tra­tion wrote in an analy­sis post­ed on Tues­day, pro­vid­ing a boost to the in­dus­try that has thrived in its large­ly Lais­sez-faire ecosys­tem.

Re­pub­li­cans and De­moc­rats both ar­gue drug prices in the Unit­ed States are too high. The De­moc­rats’ drug pric­ing bill — HR 3, un­veiled by Speak­er Nan­cy Pelosi in Sep­tem­ber — could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face an ex­cise tax of up to 95% of sales, which in turn could trig­ger fi­nan­cial loss­es due to drug sales.

Law­mak­ers left, right and cen­ter are de­vis­ing their own plans to help Amer­i­can pa­tients nav­i­gate the ex­pen­sive health­care sys­tem — but so far no­body can agree on just how to make it great again. Mean­while, the Pelosi leg­is­la­tion ig­nit­ed crit­i­cism from some Re­pub­li­cans and De­moc­rats, who fear it would chill in­vest­ment in phar­ma­ceu­ti­cal re­search and sti­fle in­no­va­tion. That’s the track tak­en by Big Phar­ma — which holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self. A clutch of biotech ven­ture cap­i­tal­ists who claim to have in­vest­ed a com­bined $20 bil­lion in the in­dus­try al­so ex­pressed their frus­tra­tion with the bill, sug­gest­ing in­no­va­tion will be un­jus­ti­fi­ably com­pro­mised.

A pre­lim­i­nary analy­sis pub­lished by the Con­gres­sion­al Bud­get Of­fice (CBO) in Oc­to­ber es­ti­mat­ed the bill would shave fed­er­al di­rect spend­ing for Medicare by $345 bil­lion over the 2023-2029 pe­ri­od, but cau­tioned that the re­duc­tion in drug­mak­er rev­enues in the ex­pect­ed range of $500 bil­lion to $1 tril­lion would cul­mi­nate in ap­prox­i­mate­ly 8 to 15 few­er new drugs hit­ting the mar­ket over the in­com­ing decade.

But it looks like no­body has quite worked out how many drugs the loss of $500 bil­lion to $1 tril­lion could po­ten­tial­ly take away from the Amer­i­can pub­lic. On Tues­day, the White House is­sued a state­ment, sug­gest­ing the Pelosi bill could re­sult in as many as 100 few­er drugs from reach­ing the mar­ket over the next decade, cit­ing the cal­cu­la­tions of the Coun­cil of Eco­nom­ic Ad­vis­ers (CEA), an agency with­in the ex­ec­u­tive of­fice of the Pres­i­dent.

That 100 num­ber is based on the as­sump­tion that phar­ma­ceu­ti­cal com­pa­nies typ­i­cal­ly spend 15% to 20%  of their rev­enue on R&D, which would im­ply a loss of $75 bil­lion to $200 bil­lion in R&D re­sources and the ba­sis that get­ting a drug from dis­cov­ery to ap­proval costs $2 bil­lion. Us­ing an­oth­er set of as­sump­tions, the CEA cal­cu­lat­ed the bill would al­so re­duce Amer­i­cans’ av­er­age life ex­pectan­cy by about four months.

On the flip side, the bill would save the fed­er­al gov­ern­ment an av­er­age of $34.5 bil­lion per year for the next 10 years, the White House re­port said. How­ev­er, by em­ploy­ing ‘stan­dard’ meth­ods of de­ter­min­ing health gains, the group pre­dict­ed the fall in health out­comes could cost be­tween $375 bil­lion to $1 tril­lion per year over the next decade, sug­gest­ing the bills “long-term health costs are at least 10 times larg­er than the short-term sav­ings.”

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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