Mar­tin Shkre­li, the ob­scene prankster of biotech, makes his fi­nal ex­it at Kalo­Bios

Mar­tin Shkre­li is about as far as you can get from a like­able com­pa­ny rep­re­sen­ta­tive. So we can on­ly imag­ine the sigh of re­lief at Kalo­Bios now that the bad boy of biotech has cashed out of his shares and will now be seen and heard of no more at the com­pa­ny he dragged in­to the spot­light.

Mar­tin Shkre­li at the De­vel­op­ments in the Pre­scrip­tion Drug Mar­ket: Over­sight hear­ing, 2016

In an SEC fil­ing out Mon­day morn­ing, Shkre­li re­vealed that he no longer owns any stock in Kalo­Bios, leav­ing CEO Cameron Dur­rant free and clear to run the com­pa­ny on a com­plete­ly dif­fer­ent set of ethics around prod­uct de­vel­op­ment and pric­ing.

In case you man­aged to miss this tawdry tale, Shkre­li took over Kalo­Bios last year as it was sup­pos­ed­ly near bank­rupt­cy. The for­mer fund man­ag­er had seized the cen­ter ring of pub­lic at­ten­tion when his oth­er biotech, Tur­ing, grabbed an an­cient med­i­cine called dara­prim and jacked up the price by 5000%. Shkre­li at one point said he would back down, but then prompt­ly re­neged on the promise, fur­ther in­cit­ing an on­line lynch mob. Kalo­Bios wound up in Chap­ter 11 any­way af­ter Shkre­li was shack­led and perp walked af­ter be­ing ar­rest­ed on fed­er­al fraud charges.

Cameron Dur­rant, CEO Kalo­Bios

Af­ter some months of strug­gle, Dur­rant brought Kalo­Bios out of bank­rupt­cy Ju­ly 1, with $14 mil­lion in fi­nanc­ing, a li­cense to de­vel­op a drug for Cha­gas dis­ease and plans to put one of the biotech’s an­ti­bod­ies back in­to the clin­ic. He had al­ready tied up Shkre­li’s abil­i­ty to do much with the stock in any case, and the ever de­fi­ant fig­ure was pro­hib­it­ed from try­ing to ex­er­cise any in­flu­ence over the com­pa­ny.

That’s all a moot point now that Shkre­li has re­lin­quished his shares.

In an in­ter­view with End­points Mon­day morn­ing, Dur­rant made no se­cret about how de­light­ed he is by Shkre­li’s ex­it. And he hopes that lit­tle Kalo­Bios can make a big dif­fer­ence in com­ing up with a new way for the in­dus­try to han­dle drug pric­ing, cit­ing Tur­ing, Valeant and now My­lan for the way they poked a hor­net’s nest of pub­lic out­rage.

“I think it is dis­grace­ful what those com­pa­nies have done,” said Dur­rant. Big price hikes on old drugs “may be le­gal but I think the spir­it of it is very dis­taste­ful.” Trans­paren­cy on pric­ing will now be­come para­mount.  “I think the no­tion that com­pa­nies can be opaque with what goes in­to pric­ing is over.”

You can ex­pect Kalo­Bios to move fast, he adds, with plans to ham­mer out a reg­u­la­to­ry path­way for ben­znida­zole in the treat­ment of Cha­gas dis­ease while they en­roll pa­tients in a Phase I study of lenzilum­ab for chron­ic myelomono­cyt­ic leukemia and an ef­fort to re­gain com­pli­ance with the SEC in or­der to relist on a na­tion­al ex­change.

Shkre­li sold his re­main­ing stake in the com­pa­ny to new in­vestors, which Dur­rant wasn’t able to dis­close.

Shkre­li has been back in the spot­light with the new scan­dal over My­lan’s 500% price hike on the EpiPen. While a tor­rent of hate was di­rect­ed at My­lan CEO Heather Bresch, Shkre­li was ready to leap to the com­pa­ny’s de­fense, say­ing that in­sur­ance com­pa­nies could al­ways pay the high­er price.

That led to a com­e­dy sketch by Stephen Col­bert mock­ing Shkre­li as a douche. Shkre­li re­spond­ed on Twit­ter with a crude ref­er­ence to a sex act that Col­bert could per­form on him, which was a per­fect open­ing for a joke.

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

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.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.