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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.