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.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”