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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Sanofi, Re­gen­eron gear up for new Dupix­ent fil­ing af­ter clear­ing sec­ond PhI­II for eosinophilic esophagi­tis

This fall’s harvest is proving fruitful for Dupixent.

Days after touting a clean Phase III sweep in prurigo nodularis, Sanofi and Regeneron report that their blockbuster anti-inflammatory drug has passed another Phase III test with flying colors, paving the way for regulatory filings in 2022.

It’s the second trial where Dupixent has proven effective against eosinophilic esophagitis, meeting the co-primary endpoints by spurring significant improvements in both clinical and histologic disease measures.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

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