PhRMA diss­es Marathon CEO—and PhRMA board mem­ber—Jeff Aronin af­ter lat­est price goug­ing con­tro­ver­sy

Af­ter main­tain­ing a stead­fast si­lence for the past five days, PhRMA is cut­ting Jeff Aronin loose.

The Marathon CEO and PhRMA board mem­ber trig­gered a tem­pest over his an­nounce­ment last Thurs­day evening that he would price his new­ly ap­proved steroid — a cheap, gener­ic of­fer­ing sold in many coun­tries around the world as de­flaza­cort — for $89,000 a year af­ter land­ing an ap­proval to mar­ket it for Duchenne mus­cu­lar dy­s­tro­phy. Ac­cord­ing to a num­ber of pa­tient ad­vo­cates, they’ve been buy­ing the drug from over­seas for about $1,000 a year.

On Mon­day Sen­a­tor Bernie Sanders and Con­gress­man Eli­jah Cum­mings ac­cused Aronin and Marathon of rip­ping off the sys­tem in the lat­est ex­am­ple of a drug ex­ec­u­tive look­ing to cash in af­ter gam­ing the FDA’s ap­proval process. Now PhRMA says Marathon is guilty of con­duct un­be­com­ing to the in­dus­try, launch­ing a re­view on mem­ber­ship cri­te­ria that would like­ly leave Aronin in the cold.

Their state­ment tonight:

We are pleased Marathon de­cid­ed to pause the launch of their med­i­cine to so­lic­it ad­di­tion­al in­put from pa­tients and oth­er stake­hold­ers. Their re­cent ac­tions are not con­sis­tent with the mis­sion of our or­ga­ni­za­tion. In ad­di­tion, the lead­er­ship of the PhRMA Board of Di­rec­tors has be­gun a com­pre­hen­sive re­view of our mem­ber­ship cri­te­ria to en­sure we are fo­cused on rep­re­sent­ing re­search-based bio­phar­ma­ceu­ti­cal com­pa­nies who take sig­nif­i­cant risks to bring new treat­ments and cures to pa­tients.

This is just the lat­est in a se­ries of em­bar­rass­ing con­tro­ver­sies cen­tered on charges of price goug­ing. Tur­ing CEO Mar­tin Shkre­li got it start­ed. Valeant was quick­ly swept up. And then My­lan took a turn in the pub­lic stocks. Now it’s Marathon’s time to stand in the spot­light.

Aronin protest­ed to Duchenne par­ents last Fri­day that the com­pa­ny did “heavy lift­ing” in its R&D pro­gram that jus­ti­fied the price. The re­search made valu­able con­tri­bu­tions to un­der­stand­ing the drug, he added, leav­ing the com­pa­ny in a hole that would take years to ex­tri­cate it­self from. But tri­al ex­perts told me that the kind of R&D pro­gram that Marathon did could be eas­i­ly cov­ered by a year’s worth of rev­enue from just a slice of the po­ten­tial mar­ket that he hoped to sell to.

By Wednes­day night Aronin was more of a li­a­bil­i­ty to PhRMA than a ben­e­fit. Just weeks ago the trade group be­gan an am­bi­tious mar­ket­ing cam­paign aimed at high­light­ing the con­tri­bu­tions of med­ical re­search. It was time, said PhRMA CEO Stephen Ubl in a thin­ly veiled jab at Shkre­li, for more lab coats and few­er hood­ies.

At the time, Shkre­li fired back that he had learned every­thing about rais­ing prices from Marathon.

For now, Aronin re­mains on the board at PhRMA. But his odds of mak­ing it much longer aren’t good. Marathon did not im­me­di­ate­ly re­spond to a query. And Aronin has con­sis­tent­ly re­fused to take a call from me.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.