Banned from Twit­ter, Mar­tin Shkre­li whips up a new on­line tirade in re­sponse to a mock­ing dig from PhRMA chief

Mar­tin Shkre­li

Up un­til a cou­ple of weeks ago, if any­one went af­ter Mar­tin Shkre­li, the price goug­ing ex-CEO of Tur­ing (and Retrophin be­fore that), he would im­me­di­ate­ly take to Twit­ter to fire off his pro­fan­i­ty-laced coun­ter­at­tacks. But then the for­mer biotech ex­ec, await­ing tri­al on fraud charges this sum­mer, was banned from Twit­ter for a se­ries of creepy tweets about his “love” for Lau­ren Duca, a Trump crit­ic who had spurred his in­stant-ire per­sona in­to ac­tion.

But no one banned Mar­tin “The Most Hat­ed Man in the World” Shkre­li from the In­ter­net and YouTube.

So when PhRMA CEO Stephen Ubl mocked him on CN­BC to­day, say­ing that we were in need of few­er hood­ies — what Shkre­li wore for his perp walk a few months back — and more lab coats, he whipped up an in­stant web site at phar­maskele­ and then nar­rat­ed his blow­back on YouTube.

“Steve, what I want­ed to tell you, as CEO of PhRMA, you are a Wash­ing­ton lob­by­ist piece of s@$t,” said Shkre­li. “You have done noth­ing for phar­ma. You’re not an evan­ge­list. You don’t know any­thing about phar­ma­ceu­ti­cals. We need to drain the swamp of id­iots like you…. I’ve done what it takes to build a bil­lion-dol­lar phar­ma­ceu­ti­cal com­pa­ny…What the f!*ck do you think you know about phar­ma­ceu­ti­cals?”

On the web site, Shkre­li writes:

Tur­ing is a small com­pa­ny re­search­ing drugs for rare dis­eases that no one else wants to. All of your mem­ber com­pa­nies, with a few hu­mor­ous ex­cep­tions, have bil­lions of dol­lars and don’t need price in­creas­es. I’m sor­ry if my com­pa­ny’s and pa­tients’ sur­vival is in­con­ve­nient to your gi­gan­tic in­come streams.

Look in the mir­ror. This web­site took me half an hour to make, just ‘mem­ber­ing a few mo­ments from the past. Phar­ma is a won­der­ful in­dus­try that does great things, but try­ing to throw me un­der the bus is fool­ish. Let me re­mind you 90% of your mem­bers’ CEOs could not hold a can­dle to me in sci­en­tif­ic knowl­edge, achieve­ments or wealth and en­tre­pre­neur­ial achieve­ments.

And so on.

Stephen Ubl

Ubl was on CN­BC to tout the in­dus­try lob­by­ing group’s plans for a ma­jor ad­ver­tis­ing cam­paign that aims to shore up pub­lic opin­ion at a time that the drug in­dus­try is stuck with one of the worst rep­u­ta­tions of any in­dus­try shy of used car sales — and that’s a maybe. Trump’s re­cent tirade against phar­ma in­clud­ed the com­ment that drug com­pa­nies have been “get­ting away with mur­der” on drug prices.

There’s no love lost be­tween Shkre­li and bio­phar­ma. BIO kicked Tur­ing and Shkre­li out of the or­ga­ni­za­tion af­ter his 5000-plus% hike on the old gener­ic Dara­prim, which al­so earned a quick di­a­tribe from the young phar­ma dude. (We’ve al­so had a few ex­changes, in which Shkre­li likes to tell me I’m a mo­ron who can’t write. But then Shkre­li gets along with few jour­nal­ists.) He’s al­so not a big fan of most mem­bers of Con­gress, who re­cent­ly spelled out the biotech ex­ec’s plan to scam a quick bil­lion off of the Dara­prim play.

This time, Shkre­li was so an­gry he went on a rant against a whole laun­dry list of PhRMA mem­bers for var­i­ous in­frac­tions of one kind or an­oth­er. Shkre­li’s bot­tom line: Tur­ing is just a small-time play­er com­pared to com­pa­nies like Al­ler­gan, Pfiz­er, etc., etc.

The in­dus­try’s lead­ers would prob­a­bly love to see Shkre­li hauled in front of a judge and ju­ry, though he’ll nev­er face charges on price goug­ing. That’s le­gal in the US. And that’s al­so not in PhRMA’s nar­ra­tive.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.

UP­DAT­ED: No­var­tis' plans to wres­tle Eylea mar­ket share take a hit as Beovu is linked to safe­ty con­cerns

While Regeneron’s flagship eye therapy Eylea hurtles towards a patent cliff, the sales of its main rival — Novartis’ Beovu — could be tainted by safety concerns.

On Sunday night, Chicago-based American Society of Retina Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis (including 11 cases of occlusive retinal vasculitis) — a sight-threatening inflammatory eye condition that involves the retinal vessels — across 46,000 injections administered since Beovu’s launch in November 2019, Wall Street analysts reported.

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UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115M and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS-CoV-2, and to prevent new ones.