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.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.