The current state of Cuban's Houston-based manufacturing facility.

Mark Cuban's new cost-plus-15% gener­ic drug com­pa­ny is re­al­ly a com­pound­ing phar­ma­cy

Shark Tank’s Mark Cuban made a splash last week in the world of drug pric­ing, pledg­ing to cut out cost­ly PBMs and de­liv­er on a very sim­ple plan with his new phar­ma­cy, and some huge cost sav­ings for con­sumers.

Mark Cuban

The com­pa­ny, known as Mark Cuban Cost Plus Drug Com­pa­ny, pledges to on­ly charge a 15% mark-up for its gener­ic drugs, of­fer­ing al­ter­na­tives to a mar­ket of­ten prone to short­ages, and ex­pen­sive gener­ic drugs (think Mar­tin Shkre­li) due to lack of com­pe­ti­tion.

But while the com­pa­ny la­bels it­self a drug com­pa­ny, and pledges to get in­to gener­ic drug man­u­fac­tur­ing of its own in a Dal­las-based cGMP fa­cil­i­ty, the com­pa­ny is re­al­ly plan­ning to op­er­ate as a com­pound­ing phar­ma­cy.

Alex Osh­myan­sky

“At launch, we are plan­ning as func­tion­ing pri­mar­i­ly as a 503(b) com­pound­ing phar­ma­cy specif­i­cal­ly tar­get­ing drugs on the FDA short­age list,” CEO Alex Osh­myan­sky told End­points News via email. “That will al­low us to be more ag­ile and ad­dress drug short­ages as they arise.”

Be­com­ing a 503(b) com­pound­ing phar­ma­cy, al­so known as an out­sourc­ing fa­cil­i­ty, means the firm will be less reg­u­lat­ed than a typ­i­cal gener­ic drug com­pa­ny, but Cuban’s com­pa­ny will need to reg­is­ter with the FDA, be in­spect­ed by the FDA, and ad­here to spe­cif­ic man­u­fac­tur­ing re­quire­ments.

“We ful­ly in­tend to reg­is­ter as an out­sourc­ing fa­cil­i­ty with the FDA, though, when we are far enough along that we are el­i­gi­ble,” Osh­myan­sky said.

For now, the hun­dreds of drugs avail­able for pur­chase via the com­pa­ny’s web­site are all sourced from oth­er gener­ic man­u­fac­tur­ers.

The on­ly gener­ic drug cur­rent­ly list­ed in the FDA’s Na­tion­al Drug Code Di­rec­to­ry with Cuban’s com­pa­ny as the la­bel­er is for a gener­ic ver­sion of the an­ti-worm drug al­ben­da­zole.

“The oth­er prod­ucts will be list­ed once we are far enough along that we can be grant­ed ND­Cs,” Osh­myan­sky said.

The dis­tinc­tion be­tween op­er­at­ing as a gener­ic drug com­pa­ny and as a com­pound­ing phar­ma­cy means Cuban’s com­pa­ny like­ly won’t be sub­mit­ting its own gener­ic drug ap­pli­ca­tions to the FDA for new gener­ic prod­ucts, in­stead of pig­gy­back­ing off oth­er gener­ic drug sub­mis­sions, at least to start.

Oth­er play­ers in this field have sim­i­lar­ly pledged to crack down on drug short­ages in the US, in­clud­ing Rich­mond-based Phlow, which has vowed to end es­sen­tial med­i­cines short­ages in the US, and Utah-based non­prof­it Civi­ca Rx, which is man­u­fac­tur­ing ster­ile in­jecta­bles in short­age for hos­pi­tal clients on a cost-plus ba­sis, as well as tar­get­ing high­er-priced gener­ics via an­oth­er ini­tia­tive, where it plans to sub­mit its own AN­DAs in part­ner­ship with health plans.

But the cost com­po­nent that Cuban and Civi­ca are tar­get­ing re­mains cru­cial.

Al­lan Coukell

Al­lan Coukell, Civi­ca VP of pol­i­cy, told End­points, “For many prod­ucts, the gener­ic in­dus­try does a fan­tas­tic job of de­liv­er­ing low-cost drugs to pa­tients but there are some prod­ucts where costs re­main high so hav­ing some­one fo­cused on de­liv­er­ing those in a cost-plus mod­el is still nov­el.”

In ad­di­tion to the Cuban-backed Dal­las man­u­fac­tur­ing plant, which Osh­myan­sky said “is about half-way fin­ished with con­struc­tion,” Cuban is al­so plan­ning to run his own PBM, as well as a cash-on­ly phar­ma­cy, where con­sumers can buy more of these cost-plus-15% drugs li­censed via the on­line phar­ma­cy Truepill.

But more is com­ing, and Osh­myan­sky said the com­pa­ny has plans for a bi­o­log­ics li­cense ap­pli­ca­tion too, which will like­ly take more time to bring to mar­ket than a gener­ic drug.

“At the mo­ment, we are ac­tu­al­ly tak­ing a BLA through the FDA ap­proval process for a prod­uct we in­tend to make at the fa­cil­i­ty. We are not dis­clos­ing what the prod­uct is yet, though,” Osh­myan­sky said, not­ing that the com­pa­ny has every in­ten­tion of com­ply­ing with FDA in­spec­tions.

“Struc­tur­al steel is up now, and we are be­gin­ning to put up the walls and pip­ing next week. So noth­ing re­al­ly for the FDA to in­spect at the mo­ment, but cer­tain­ly plan to have it in­spect­ed as soon as is ap­pro­pri­ate,” he added.

Ar­ti­cle up­dat­ed to note the com­pound­ing fa­cil­i­ty is be­ing built in Dal­las, not Hous­ton.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Bris­tol My­ers, Ab­b­Vie drugs shake up first-line pre­scrib­ing among gas­troen­terol­o­gists — re­port

Bristol Myers Squibb and AbbVie are changing up the inflammatory bowel disease (IBD) market with gastroenterologists, thanks to newer-to-market drugs Zeposia and Skyrizi, respectively. The two drugs have made big gains since 2021 in first-line prescriptions, according to Spherix Global Insights’ latest real world tracking report.

Bristol Myers’ first-in-class S1P Zeposia has landed particularly strong, picking up “a sizeable portion of first line patients” in ulcerative colitis (UC), Spherix’s analysis found.

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FDA's drug short­ages leader wants com­pa­nies to start re­port­ing in­creas­es in de­mand

It is no secret that drug shortages have been prevalent in 2022. Several major drug products, such as amoxicillin and Adderall, have been in short supply for several months and have led to members of Congress applying pressure on the FDA and HHS to resolve the situation.

Speaking at a webinar hosted by the Alliance for a Stronger FDA, Valerie Jensen, the associate director of the FDA’s Drug Shortage Staff, noted both the rise in quality-related issues and increased demand for some products. She called on companies to report such demand increases, even though they are not currently required to do so.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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