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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.