The scoop: Marathon’s R&D pro­gram for Duchenne MD drug like­ly came in at a bar­gain base­ment price

On Fri­day, as news spread about the FDA’s ap­proval of Marathon Phar­ma­ceu­ti­cals’ ap­pli­ca­tion for Em­flaza (de­flaza­cort) as an or­phan drug for Duchenne mus­cu­lar dy­s­tro­phy, CEO Jeff Aronin went on the of­fen­sive over his plans to sell the drug at an $89,000 list price, which im­me­di­ate­ly drew scruti­ny from some long­time ob­servers of the in­dus­try.

Aronin pulled what has be­come a stan­dard play out of the guide book for phar­ma com­pa­nies fac­ing price goug­ing charges. He told re­porters at sev­er­al pub­li­ca­tions, in­clud­ing the Chica­go Tri­bune and the Wall Street Jour­nal, that it would take years for Marathon to be­come prof­itable, con­sid­er­ing all the R&D costs that had been sunk in­to de­flaza­cort. And — like Tur­ing founder Mar­tin Shkre­li, caught on the horns of a con­tro­ver­sy over Dara­prim pric­ing — he vowed that pa­tients would be pro­tect­ed, with pay­ers cov­er­ing the cost.

“We had to start from scratch with the FDA,” Aronin in­sist­ed on a we­bi­nar with par­ents on Fri­day, as he as­sured fam­i­lies that their out-of-pock­et costs would be “ze­ro to low cost” while in­sist­ing that the net price to in­sur­ers was based en­tire­ly on the ex­ten­sive re­search the com­pa­ny com­plet­ed.

“It was a heavy lift,” he told par­ents, “but we did all these tri­als.”

Many of those tri­als he cit­ed, though, prob­a­bly on­ly cost a few hun­dred thou­sand dol­lars. That was one piece of the puz­zle, though, that was omit­ted from Marathon’s de­fense. And you won’t hear a word about it from the FDA, which ac­tive­ly as­sist­ed at every step, hand­ing out valu­able help by step­ping up an ap­proval for a drug that has been wide­ly avail­able at a tiny frac­tion of the cost through over­seas sup­pli­ers and then capped it with a bonus that could eas­i­ly turn an overnight prof­it for Marathon.

Just like Shkre­li?

One dif­fer­ence that’s been point­ed out be­tween Aronin and Shkre­li — who re­cent­ly point­ed out that Aronin and Ova­tion, which he sold to Lund­beck for $900 mil­lion, “in­vent­ed price in­creas­es” — was that Shkre­li sim­ply hiked the price of an old drug he ac­quired for $55 mil­lion and protest­ed that he need­ed the mon­ey from the Dara­prim price hike to do more re­search in­to a bet­ter drug, while Aronin in­vest­ed in a de­vel­op­ment pro­gram for a cheap, gener­ic drug that’s been used around the world for decades to qual­i­fy for an FDA ap­proval in the US for the first time.

The com­pa­ny, Aronin main­tained, con­duct­ed 17 pre­clin­i­cal and clin­i­cal stud­ies to get this drug, plus in-li­cens­ing two old­er stud­ies. The piv­otal tri­al was com­plet­ed orig­i­nal­ly in 1995, be­fore the spon­sor aban­doned it. But the CEO re­fused to de­tail the ac­tu­al hard re­search costs. (Aronin and Marathon have al­so re­fused to re­spond to sev­er­al re­quests for an in­ter­view.)

On Fri­day, though, Marathon went one step fur­ther with the Duchenne par­ents that they’ve been court­ing as Aronin prepped for a mar­ket launch of a drug now OK’d for DMD kids 5 and old­er. In a we­bi­nar, he post­ed a slide of the tri­al pro­gram for de­flaza­cort de­tail­ing the pre­clin­i­cal and clin­i­cal ef­fort.

The we­bi­nar was host­ed by Par­ent Pro­ject Mus­cu­lar Dy­s­tro­phy, one of sev­er­al par­ent groups that counts Marathon as a cor­po­rate spon­sor, which al­so post­ed a link to the event.

Marathon Slide

The slide cites the two old ef­fi­ca­cy stud­ies they ac­quired along with de­tails on 9 pre­clin­i­cal stud­ies, in­clud­ing a mon­key tri­al and two rat stud­ies.

Marathon’s clin­i­cal pro­gram in­volved no new reg­is­tra­tional stud­ies, the pri­ma­ry dri­ver be­hind R&D costs.

There were projects like a drug/drug in­ter­ac­tion study and an ADME study (a stan­dard ab­sorp­tion, dis­tri­b­u­tion, me­tab­o­lism and ex­cre­tion study) and so on. They al­so start­ed an ex­tend­ed ac­cess pro­gram as they put more boys on the steroid ahead of the US mar­ket­ing launch.

Man­u­fac­tur­ing costs for this drug are clear­ly just a frac­tion of what Marathon will be charg­ing, based on the cur­rent price in the UK and Cana­da.

I hand­ed the slide on to two tri­al ex­perts, Bernard Munos, an Eli Lil­ly vet­er­an now run­ning In­no­Think, and David Grainger, who’s found­ed a slate of biotechs from his base at Medicxi in Lon­don. They both ran cost es­ti­mates on what it would take to do this kind of pro­gram.

What did it re­al­ly cost?

Munos and Grainger each came up with a fi­nal fig­ure not far off from what Shkre­li paid to lay his hands on Dara­prim. But they have two dis­tinct­ly dif­fer­ent views of the re­search costs.

Munos turned to G. Sit­ta Sit­tam­palam, an­oth­er de­vel­op­ment vet at Lil­ly who has been close­ly in­volved with the Ther­a­peu­tics for Rare and Ne­glect­ed Dis­eases pro­gram at NIH’s Na­tion­al Cen­ter for Ad­vanc­ing Trans­la­tion­al Sci­ences and with drug re­pur­pos­ing for leukemia at Kansas Uni­ver­si­ty Med­ical Cen­ter.

“From his ex­pe­ri­ence,” notes Munos, “the pre­clin­i­cal work for Em­flaza (the 9 tox stud­ies in red on their slide) can be es­ti­mat­ed at $5-10 mil­lion, and the clin­i­cal de­vel­op­ment pro­gram at $50-60 mil­lion.”

“The stud­ies from the 1990s that Marathon ac­quired were like­ly cheap (<$5 mil­lion) since they were old da­ta that had ba­si­cal­ly no val­ue when they were ac­quired; and from Marathon CEO’s ad­mis­sion need­ed a fair amount of “cleanup” to be us­able. That puts the en­tire pack­age at $65-75 mil­lion.”

Grainger, who spe­cial­izes in low-cost biotech star­tups, looked up the stud­ies he could find on­line, ran the num­bers for the whole thing, and con­clud­ed that this could all be done for much, much less. But his po­ten­tial ini­tial val­u­a­tion for the com­pa­ny al­so reach­es fair­ly close to the $55 mil­lion that Shkre­li paid for Dara­prim be­fore trig­ger­ing his own well-doc­u­ment­ed scheme to rip off the sys­tem.

The whole pre­clin­i­cal ef­fort at Marathon, Grainger says, could be done for less than $2 mil­lion, in­clud­ing $600,000 for a 9-month mon­key study of tox­i­c­i­ty. The clin­i­cal pro­gram is hard­er to map out en­tire­ly, but if you in­clude a max­i­mum amount of $400,000 for a US ADME study, $400,00 for a food ef­fect study and $720,000 for the ex­ten­sion study, it’s not hard to see that Marathon was look­ing at a small over­all bud­get. He added, though, that it was hard to fig­ure what the com­par­i­son study on Cal­cort — the drug sold in the UK — would cost, as it’s not list­ed on clin­i­cal­tri­als.gov.

Then there was over­head. Medicxi likes to run vir­tu­al com­pa­nies, and he es­ti­mates that if this was their op­er­a­tion, they would re­serve $2 mil­lion for over­head, plus $500,000 for ex­ter­nal reg­u­la­to­ry as­sis­tance. “They very prob­a­bly had a larg­er team than we would have had, though,” he adds.

“So that comes to just over $6 mil­lion in to­tal,” he notes in a break­down, “which feels about right to me. If some­one came to Medicxi propos­ing to de­liv­er that op­er­at­ing plan, and want­ed to raise $10 mil­lion to do it, we would think that was a gen­er­ous, but prob­a­bly not out­ra­geous, amount of mon­ey. If any­one told me it would cost them much more than $10 mil­lion, then I’d laugh and say you must be do­ing it wrong!”

“Re­gard­ing your last ques­tion, I can’t of course es­ti­mate what the li­cense to the ef­fi­ca­cy da­ta might have cost. That is, as you say, a wild-card. But if Marathon had come to Medicxi with this pro­pos­al and sug­gest­ed a pre-mon­ey val­u­a­tion of more than $25 mil­lion we would prob­a­bly have walked away. Oth­ers might be more gen­er­ous, but I find it hard to be­lieve it was more than $50 mil­lion.”

The 1% so­lu­tion

To put those es­ti­mates in­to some added con­text, the phar­ma in­dus­try likes to use fig­ures that show the av­er­age cost of new drug de­vel­op­ment is $2.6 bil­lion per ap­proved ther­a­py, all in. Marathon’s cost for R&D — or its ini­tial val­u­a­tion — would have been sig­nif­i­cant­ly less than 1% to 3% of that fig­ure, based on the es­ti­mates I ob­tained.

Marathon claims that its $89,000 list price will net out at around $54,000 a year af­ter dis­counts. Based on their low­er net es­ti­mat­ed price, the R&D bud­get — based on the Munos es­ti­mate — would be the same as the cost for treat­ing few­er than 1,400 pa­tients over the course of 1 year, or rough­ly 8% of the mar­ket. If you use Grainger’s num­bers, it would take few­er than 200 pa­tients to cov­er a bare­bones R&D ef­fort at the claimed net price.

At the list price, it would take a max­i­mum of cov­er­ing 115 pa­tients for a year to cov­er Grainger’s R&D es­ti­mate, and that’s with­out sell­ing the pri­or­i­ty re­view vouch­er they ob­tained from the FDA with the ap­proval — which could eas­i­ly be worth far more than the en­tire re­search/over­head bud­get for Marathon.

Quite a few Duchenne MD par­ents have been turn­ing to Mas­ters Glob­al in the UK for years to buy this drug — an old gener­ic steroid stan­dard avail­able for decades in Cana­da, the UK, etc — for around $1,200 a year. But once the FDA ap­proved it, that and oth­er life­lines got cut off. Now, to ob­tain this steroid, they’ll have to use Marathon’s sup­ply or find a way to cir­cum­vent the law.

Marathon’s price sound­ed like prof­i­teer­ing to peo­ple look­ing at a min­i­mum overnight price hike of about 6000%, a close match to Tur­ing’s 5000% price hike for Dara­prim, which land­ed Shkre­li in a Con­gres­sion­al spot­light. The com­pa­ny’s whole­sale price is al­so un­com­fort­ably close to the con­tro­ver­sial 6-fig­ure prices charged for many new can­cer drugs that spent years in the clin­ic, with the da­ta pub­lished in peer-re­viewed pub­li­ca­tions.

Chris­tine Mc­Sh­er­ry

“They main­tain that the drug is go­ing to be free (to fam­i­lies), with no out-of-pock­et costs,” says Chris­tine Mc­Sh­er­ry, an out­spo­ken cham­pi­on for Sarep­ta’s Ex­ondys 51 who runs The Jett Foun­da­tion. “But it af­fects all of us, all of us. It im­pacts our pre­mi­ums” and may well fac­tor in­to life­time caps on in­sur­ance cov­er­age for a host of Duchenne fam­i­lies. Now Marathon is forc­ing them to add an $89,000 drug to a $300,000 a year drug, she adds, which “at the end of the day is a steroid.”

By her own es­ti­mate, Marathon is rais­ing the cost of a drug that she had paid $2.04 a pill for to $148.33, a hike of more than 7000%.

“At $10,000, come on, you’re still go­ing to make mon­ey,” says Mc­Sh­er­ry. “It puts a bad taste in your mouth.”

How big is this mar­ket?

Pa­tient ad­vo­ca­cy groups say that about 15,000 to 20,000 boys suf­fer from DMD in the US, a dis­ease that first crip­ples them and then slow­ly kills them. De­flaza­cort has be­come a stan­dard ther­a­py in this group be­cause it’s well known to be ef­fec­tive in boost­ing strength, like most steroids, with less weight gain.

Ac­cord­ing to Aronin’s pre­sen­ta­tion to Duchenne par­ents on Fri­day, de­flaza­cort cur­rent­ly is on­ly avail­able to less than 10% of the pa­tient pop­u­la­tion, with the rest cut off, un­able to ob­tain the drug or re­quired to use pred­nisone.

“Hope­ful­ly this is just a start,” Aronin said on Fri­day. “Well over 90% of pa­tients did not have ac­cess to this drug.”

Many physi­cians re­sist­ed pre­scrib­ing an un­ap­proved drug, as many moth­ers re­sist­ed a drug with­out FDA ap­proval, he claimed. “And even, un­for­tu­nate­ly cost” was a fac­tor. “Most pa­tients did not have ac­cess to this drug.”

Ap­proval was the on­ly way to gain ac­cess to this drug, he in­sist­ed. Yes, he added, it took over 6 years, “was a bur­den…The rea­son we got this ap­proved was that so every­body would have ac­cess to this prod­uct.” And now it will be avail­able for low or no cost, with a se­cure, FDA ap­proved safe source for the drug.

“We had to do a lot of of oth­er stud­ies “ to sat­is­fy the FDA, Tim Cu­niff, Marathon’s EVP of drug de­vel­op­ment told par­ents on Fri­day. The food ef­fect study showed no ef­fect of food on dosage. The Cal­cort stur­dy looked at switch­ing from the im­port­ed UK drug, and found sim­i­lar blood lev­els with their ver­sion of de­flaza­cort.

How about off-la­bel pa­tients un­der 5, who weren’t ap­proved for the drug?

Cu­niff re­peat­ed­ly sug­gest­ed that the un­der-5 kids could get the drug cov­ered as well.

“We would ex­pect that an in­sur­er, es­pe­cial­ly for pa­tients al­ready on drug, would fill that pre­scrip­tion,” he added, ex­plain­ing how the com­pa­ny planned to launch a tri­al for tod­dlers. “We’ll han­dle that on a case-by-case ba­sis,” he added, with flex­i­bil­i­ty on com­pas­sion­ate use for the drug.

The block­buster case for de­flaza­cort

But Mc­Sh­er­ry says that fig­ure on pa­tients who have ob­tained de­flaza­cort to date would ap­pear to be a gross un­der­es­ti­mate, based on her per­son­al ex­pe­ri­ence net­work­ing with the tight-knit Duchenne com­mu­ni­ty. None of the par­ents she talks with have had the is­sues Marathon cit­ed in ob­tain­ing the drug. Af­ter reg­u­lar­ly polling Duchenne par­ents about de­flaza­cort, Mc­Sh­er­ry ini­tial­ly es­ti­mat­ed that 40% to 50% of the DMD kids are al­ready on de­flaza­cort and will now be forced to switch to Marathon’s sup­ply, then ad­just­ed that down to a con­ser­v­a­tive 25%.

But there’s no guar­an­tee they can stay on de­flaza­cort now, she adds, par­tic­u­lar­ly if in­sur­ers re­quire them to use pred­nisone, a gener­ic steroid in the US that is sold for pen­nies a pill. And that rais­es big is­sues for pa­tients as well, as pred­nisone — which is not ap­proved for Duchenne MD – is clear­ly not the pre­ferred steroid for Duchenne.

If half of all US pa­tients are put on Marathon’s steroid, that’s at least $405 mil­lion gross a year — $33.7 mil­lion a month — based on their low­er $54,000 an­nu­al net price. The to­tal mar­ket could be worth up to a block­buster bil­lion dol­lars-plus a year in an­nu­al rev­enue.

Be­cause the FDA gave them or­phan sta­tus, Marathon has a 7-year ex­clu­siv­i­ty deal for de­flaza­cort. Based on the com­pa­ny’s whole­sale price of $89,000, that mar­ket is the­o­ret­i­cal­ly worth up to $12.6 bil­lion in to­tal through the full stretch.

The pri­or­i­ty re­view vouch­er giv­en by the FDA with the ap­proval — in recog­ni­tion of its rare dis­ease sta­tus — would cov­er all of Marathon’s R&D costs in­stant­ly, even if it doesn’t come any­where near to fetch­ing the top $350 mil­lion price Ab­b­Vie paid for one of these vouch­ers in 2015.

De­flaza­cort won’t bring in all the high-end mon­ey. But based on ex­pert es­ti­mates, they have the po­ten­tial to blow past their re­search in­vest­ment with just a few months worth of rev­enue when it’s all up and run­ning.

That’s some­thing, though, you’ll nev­er hear from Marathon.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.

Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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