Marathon CEO tries to call a time out on con­tro­ver­sy as law­mak­ers rip in­to $89K de­flaza­cort price

Sen­a­tor Bernie Sanders and Con­gress­man Eli­jah Cum­mings have found their new poster boy for phar­ma price goug­ing. His name is Jeff Aronin, the CEO of Marathon Phar­ma­ceu­ti­cals.

In a joint let­ter ad­dressed to Aronin, the two law­mak­ers slammed the com­pa­ny’s “out­ra­geous plans” to set a list price of $89,000 on their new­ly ap­proved de­flaza­cort, a cheap steroid that’s been avail­able for decades in oth­er coun­tries around the world. And they launched an in­ves­ti­ga­tion in­to Marathon’s plans, de­mand­ing doc­u­ments re­lat­ed to the ac­tu­al cost of the pro­gram while in­sist­ing that Marathon “sig­nif­i­cant­ly low­er the price” for re­leas­ing the drug.

The let­ter cites sto­ries from End­points News, The Wash­ing­ton Post, Stat and oth­ers.

Al­most si­mul­ta­ne­ous­ly, Marathon ex­e­cut­ed a strate­gic re­treat, telling a group of rep­re­sen­ta­tives from var­i­ous Duchenne groups at a pol­i­cy meet­ing in Wash­ing­ton DC that they were call­ing a “pause on the launch,” ac­cord­ing to one of the at­ten­dees, who asked not to be iden­ti­fied.

Var­i­ous Marathon rep­re­sen­ta­tives were at the meet­ing, in­clud­ing mar­ket­ing chief Er­ic Mesnner and de­vel­op­ment chief Tim Cun­niff, and a state­ment from Aronin was read out as­sur­ing the Duchenne com­mu­ni­ty that they would still be able to or­der de­flaza­cort from Mas­ters Glob­al in the UK “un­til we fig­ure this out.”

In his state­ment, Aronin re­peat­ed his ear­li­er, wide­ly dis­put­ed po­si­tion that the com­pa­ny’s pri­ma­ry in­ter­est was in bring­ing the steroid to pa­tients who cur­rent­ly can’t get it. He pledged:

“We will meet with care­givers and ex­plain our com­mer­cial­iza­tion plans, re­view their con­cerns, dis­cuss all op­tions, and move for­ward with com­mer­cial­iza­tion based on an agreed plan of ac­tion.”

That will re­quire some quick foot­work with law­mak­ers.

“Marathon did not de­vel­op de­flaza­cort,” Sanders and Cum­mings wrote. “Rather Marathon ac­quired the rights to his­tor­i­cal clin­i­cal tri­al da­ta from the 1990s and com­plet­ed some ad­di­tion­al analy­ses to gain ap­proval from the Food and Drug Ad­min­is­tra­tion to sell the drug in the Unit­ed States.

“We be­lieve that Marathon is abus­ing our na­tion’s or­phan drug pro­gram, which grants com­pa­nies sev­en years of mar­ket ex­clu­siv­i­ty to en­cour­age re­search in­to new treat­ments for rare dis­eases, not to pro­vide com­pa­nies like Marathon with lu­cra­tive mar­ket ex­clu­siv­i­ty rights for drugs that have been avail­able for decades.”

As we re­port­ed this morn­ing, Marathon has made much out of its R&D ef­forts, say­ing the price was jus­ti­fied by the amount that was spent to gain an ap­proval. Tri­al ex­perts, though, say it could have been done for any­thing from less than $10 mil­lion to a high of $75 mil­lion, a sum that could be eas­i­ly cov­ered just by the sale of the pri­or­i­ty re­view vouch­er that it ob­tained from the ap­proval.

The lat­est pric­ing con­tro­ver­sy wasn’t over­looked by pay­ers and drug ben­e­fit man­agers.

“As you might ex­pect,” not­ed a spokesper­son for Ex­press Scripts in a mes­sage to me, “we be­lieve this is an­oth­er ex­am­ple of egre­gious pric­ing for an old drug that is avail­able else­where for much less.”

Marathon has con­sis­tent­ly re­fused to re­spond to my re­peat­ed re­quests for an in­ter­view with Aronin, whose broth­er, J&J vet Greg Aronin, works as a lob­by­ist for the com­pa­ny.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.