The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Phar­ma bro Mar­tin Shkre­li was jailed, pub­licly pil­lo­ried and forced to con­front some law­mak­ers in Wash­ing­ton riled by his move to take an old gener­ic and move the price from $17.50 per pill to $750. But through 4 years of con­tro­ver­sy and pub­lic re­vul­sion, his com­pa­ny nev­er backed away from the price — left un­con­trolled by a lais­sez faire fed­er­al pol­i­cy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fin­gers off the drug once and for all and open it up to some cheap com­pe­ti­tion. And their law­suit is ask­ing that Shkre­li — with sev­er­al years left on his prison sen­tence — be banned per­ma­nent­ly from the phar­ma in­dus­try.

Gail Levine

In a joint ac­tion tak­en Mon­day, the two groups ac­cused Shkre­li — the poster boy for pric­ing re­form — and one of his close as­so­ciates of “an elab­o­rate an­ti­com­pet­i­tive scheme to pre­serve a mo­nop­oly for the life-sav­ing drug, Dara­prim.”

Gail Levine, deputy di­rec­tor of the Bu­reau of Com­pe­ti­tion at the Fed­er­al Trade Com­mis­sion, ac­cused Shkre­li’s com­pa­ny Vy­era of keep­ing “the price of Dara­prim as­tro­nom­i­cal­ly high by il­le­gal­ly box­ing out the com­pe­ti­tion.”

Shkre­li and the com­pa­ny knew from the start that once they set the price at $750 per pill they’d be vul­ner­a­ble to gener­ic ri­vals that would squeeze out prof­its, his ac­cusers claim in a law­suit. As a re­sult, Shkre­li kept a grip on dis­tri­b­u­tion to make sure that gener­ic drug­mak­ers would nev­er have the sam­ples they would need to make a knock­off. They al­so blocked ac­cess to sales rev­enue num­bers to make sure no one could ac­cu­rate­ly size up the mar­ket — fur­ther block­ing com­pe­ti­tion.

Ac­cord­ing to the fed­er­al law­suit:

Ab­sent De­fen­dants’ an­ti­com­pet­i­tive con­duct, Dara­prim would have faced gener­ic com­pe­ti­tion years ago. In­stead, tox­o­plas­mo­sis pa­tients who need Dara­prim to sur­vive have been de­nied the op­por­tu­ni­ty to pur­chase a low­er-cost gener­ic ver­sion, forc­ing them and oth­er pur­chasers to pay tens of mil­lions of dol­lars a year more for this life-sav­ing med­ica­tion

For all the anger Shkre­li stirred ahead of his fraud con­vic­tion — with his quick turn to so­cial me­dia bad boy, caus­ti­cal­ly call­ing out his crit­ics — the feds were nev­er able to lay a hand on Dara­prim. As the pub­lic up­roar over price goug­ing on drugs grew ever more heat­ed, Shkre­li be­came a rep­re­sen­ta­tive of the in­dus­try — which the in­dus­try ve­he­ment­ly wished would just go away. And that didn’t stop with his 7-year sen­tence on fraud charges re­lat­ed to the hedge funds he ran in­to the ground.

Shkre­li was trans­ferred from his first prison af­ter the Wall Street Jour­nal re­port­ed that he had con­tin­ued to op­er­ate his biotech with a con­tra­band cell phone.

The FTC and New York ev­i­dent­ly plan to fin­ish the job once and for all.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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New Chroma Medicine board member Jeff Marrazzo

Jeff Mar­raz­zo has found a buzzy new biotech cause to cham­pi­on. And once again, he's all in

Jeff Marrazzo is one of those biotech execs who has always been focused on the next big goal. He has a track record for meeting objectives, relentlessly staying on message, and breaking new ground.

The fact that he stayed around for a couple of years after Roche’s $4.3 billion Spark buyout, making sure the organization he founded weathered Covid-19, is one example. And that came after he carefully guided the company to the first-ever US approval of a gene therapy — no easy task.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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