BioReg­num: The mob is back. And what's to stop them from go­ing af­ter the en­tire bio­phar­ma in­dus­try?

John Car­roll, Ed­i­tor

My­lan to­day is at the cen­ter of the lat­est on­line mael­strom to erupt over drug pric­ing and ac­cess to ther­a­pies. And while it hun­kers down to see if it can wait out the storm that has erupt­ed over the EpiPen, the one man who can do it the most dam­age is rid­ing to its res­cue.

En­ter Mar­tin Shkre­li, for­mer biotech CEO and the most wide­ly hat­ed in­di­vid­ual in bio­phar­ma his­to­ry. Shkre­li spe­cial­ized in taunt­ing the dig­i­tal lynch mob that formed af­ter he raised the price of an an­cient drug called dara­prim by more than 5000% af­ter snatch­ing it up for a song. And he kept the crowd stirred by reneg­ing on a promise to roll back the price.

The Shkre­li de­fense — re­lax, in­sur­ance can pay for most of it — won’t fly. But that didn’t stop him from rolling it back out any­way.

“My­lan’s a good guy,” Shkre­li told CBS. “They have one prod­uct where they’re fi­nal­ly start­ing to make a lit­tle bit of mon­ey and every­one’s go­ing crazy over it….That’s up to in­sur­ance to pay for them,” he replied to a ques­tion. “It’s $300 a pen. $300. My iPhone is $700…. It’s $300 and 90% of Amer­i­cans are in­sured.”

This is some­thing like hav­ing a se­r­i­al killer ap­pear as a char­ac­ter wit­ness at your mur­der tri­al.

Mar­tin Shkre­li at the De­vel­op­ments in the Pre­scrip­tion Drug Mar­ket: Over­sight hear­ing, 2016

My­lan got in­to this po­si­tion by fol­low­ing the same strat­e­gy as Shkre­li, buy­ing an old prod­uct and jack­ing up the price, but fol­lowed a less risky ap­proach by tak­ing some time to do it. It blew up in­to a scan­dal in any case. And now the com­pa­ny is tak­ing the place of Valeant, which fol­lowed the same ap­proach and got shred­ded by the fall­out.

My­lan, Valeant and the rest of Big Phar­ma rou­tine­ly en­gaged in price goug­ing for the sim­ple rea­son that they can. No law ex­ists that pre­vents it. But hop­ing that the mob won’t sud­den­ly ap­pear at its door — along with Shkre­li — isn’t a vi­able strat­e­gy any more.

Bio­phar­ma needs to swear off this ad­dic­tion to price goug­ing and en­gage in some roll­backs, start­ing with My­lan. Com­pa­nies can pub­licly state that they’re op­posed to it and will stop the prac­tice, be­cause it is un­eth­i­cal. And if they don’t take the pledge, they can bear the con­se­quences. Oth­er­wise, every­one can face off against the grow­ing clam­or for drug pric­ing re­form in Con­gress.

This is an in­dus­try cri­sis. And the in­dus­try needs to re­spond. This whole pric­ing struc­ture for drugs is un­sus­tain­able in the US. It’s nice to ex­per­i­ment with new ap­proach­es like pay­ing for the right out­comes, but change has to hap­pen now. The al­ter­na­tive is to face con­trols on pric­ing for new and im­por­tant drugs, where com­pa­nies have a very good ar­gu­ment for charg­ing some very high rates.

Some­thing’s got to give.

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

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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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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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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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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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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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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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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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