Mark Cuban (Brandon Wade/AP Images)

Mark Cuban jumps out of the Shark Tank and in­to gener­ic phar­ma with a plan to of­fer dirt-cheap drugs

The call for a whole­sale rewrite of drug pric­ing has tak­en on a fever pitch in re­cent years, reg­u­lar­ly be­com­ing part of pres­i­den­tial stump speech­es and con­gres­sion­al horse trad­ing. The fo­cus is usu­al­ly on high-price brand­ed meds, but now a new shark is in the wa­ter go­ing af­ter pricey gener­ics as well.

In an ef­fort to of­fer low-cost al­ter­na­tives to pricey gener­ic med­i­cines, bil­lion­aire in­vestor Mark Cuban has put his name to a new com­pa­ny dubbed Mark Cuban Cost Plus Drugs — an on-the-nose moniker for sure, but one with the se­ri­ous am­bi­tion of un­der­cut­ting the mar­ket on tar­get­ed meds.

The new com­pa­ny’s ver­sion of rad­i­cal trans­paren­cy will in­clude di­vulging its cost of de­vel­op­ment and dis­tri­b­u­tion and then adding a flat 15% mar­gin on­to all prod­ucts for whole­sale — enough, it says, to of­fer a cheap al­ter­na­tive for high-price meds.

The goal is even­tu­al­ly to launch more than 100 drugs on­to the mar­ket by the end of this year, but the firm will start with an­tipar­a­sitic al­ben­da­zole, which it says it will of­fer at an av­er­age price per tablet of $20 com­pared with the cur­rent av­er­age of $225 MSRP. For in­sured pa­tients, that price could go “as low as a dol­lar,” the com­pa­ny said on its web­site.

“Our low cost al­ben­da­zole prod­uct al­lows physi­cians to af­ford­ably treat hook­worm out­breaks through­out Amer­i­ca that were pre­vi­ous­ly too ex­pen­sive to treat sys­tem­i­cal­ly be­fore,” the com­pa­ny wrote.

While de­tails are scant on where the com­pa­ny will source its med­i­cines in the short term, it is plan­ning to build a new man­u­fac­tur­ing site in Dal­las — true to Cuban’s roots — by 2022. A re­quest for com­ment was not an­swered by press time.

Drug­mak­ers look­ing to rewrite the rules of pric­ing are noth­ing new in an in­dus­try where the list price of drugs has be­come a hot-but­ton po­lit­i­cal is­sues. How­ev­er, those cru­sades are usu­al­ly in the world of brand­ed med­i­cines, where cor­nered mar­kets can pro­duce in­flat­ed prices.

Just last week, dis­rup­tive biotech EQRx snagged a $500 mil­lion Se­ries B to pur­sue its ver­sion of a pric­ing re­work, pledg­ing to bring cost-ef­fec­tive on­col­o­gy and im­munol­o­gy meds to mar­ket. That will be­gin with four can­cer drugs it has in-li­censed and which could be ready for mar­ket with­in the next two years.

But go­ing af­ter gener­ic drugs — a mar­ket where the go­ing think­ing is prices are al­ready com­pet­i­tive — is a rel­a­tive­ly unique twist, and Cuban’s in­volve­ment ob­vi­ous­ly adds some heft to the mis­sion state­ment.

But the com­pa­ny could have a dual pur­pose in hit­ting the mar­ket when it did. With the Covid-19 pan­dem­ic shut­ting down sup­ply chains for gener­ic med­i­cines around the world, politi­cians and in­vestors have called for re­dun­dan­cy in sup­ply on US shores, look­ing to lim­it the in­flu­ence of Chi­na and In­dia, two of the lead­ing play­ers in fin­ished gener­ic med­i­cines and in­gre­di­ents.

The Trump ad­min­is­tra­tion over the course of the pan­dem­ic has float­ed mas­sive fund­ing of­fers for a few of those tar­get­ed com­pa­nies, some with big names. In the case of Ko­dak, most fa­mous for its cam­eras, the gov­ern­ment in­vest­ment arm, the De­vel­op­ment Fi­nance Cor­po­ra­tion, of­fered a $765 mil­lion loan to get their own gener­ics phar­ma en­try off the ground. But ac­cu­sa­tions of in­sid­er trad­ing and an SEC in­ves­ti­ga­tion even­tu­al­ly sent that ini­tia­tive in­to a tail­spin in Au­gust.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.

Simba Gill, Evelo Biosciences CEO

Sim­ba Gill heads back to Flag­ship af­ter sev­en-year run as Evelo CEO

Evelo Biosciences is on the hunt for a new CEO, with its founding chief Simba Gill switching to the chairman post to free up time for his new gig at Evelo’s incubator, Flagship Pioneering.

Gill will trade in his former Flagship title of venture partner with the higher-up role of executive partner, after originally joining in 2015. He’ll serve as CEO of Evelo until his successor is chosen, and at Flagship his priorities will be counseling and supporting the venture firm’s portfolio companies.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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