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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.