Mark Pruzanski, Intercept CEO (GlobeNewswire via YouTube)

Long­time In­ter­cept CEO Mark Pruzan­s­ki de­parts as ail­ing NASH com­pa­ny tries to find its fu­ture

Mark Pruzan­s­ki, the CEO who turned “NASH” in­to a house­hold name around biotech, guid­ed his com­pa­ny to the precipice of a nascent field and then watched it fal­ter in the wake of a CRL, will step down on Jan­u­ary.

Jerome Dur­so

In­ter­cept Phar­ma­ceu­ti­cals an­nounced Tues­day that Pruzan­s­ki, who has led the biotech since its found­ing, will be re­placed by Jerome Dur­so, a long­time Sanofi ex­ec­u­tive and the COO of In­ter­cept since 2017. Dur­so will take the reins of a com­pa­ny fac­ing a dif­fi­cult road for­ward, as the com­pa­ny tries to con­vince the FDA to re­think its de­ci­sion to re­ject their lead drug for NASH, cut­ting the stock and forc­ing lay­offs.

Pruzan­s­ki will stay on as a board mem­ber.

“This is a piv­otal time for the com­pa­ny as we ad­vance our foun­da­tion­al rare liv­er dis­ease busi­ness and work to­wards the po­ten­tial re­sub­mis­sion of our NDA in NASH fi­bro­sis,” Dur­so said in a state­ment. “I am con­fi­dent that we will lever­age our core strengths and ca­pa­bil­i­ties across the busi­ness to ex­e­cute on plans for con­tin­ued growth and ad­vance­ment of our pipeline to dri­ve the fu­ture suc­cess of In­ter­cept.”

Pruzan­s­ki, then a young ven­ture cap­i­tal­ist at Ap­ple Tree Part­ners, found­ed In­ter­cept in 2002 with the Ital­ian doc­tor Rober­to Pel­lic­cia­ri, who had syn­the­sized mol­e­cules that could be used as liv­er drugs. Af­ter years of ear­ly de­vel­op­ment, he has led the com­pa­ny through a decade of ups and downs. At JPM 2014, two years af­ter go­ing pub­lic, the com­pa­ny an­nounced pos­i­tive Phase II re­sults in NASH, a lit­tle-known fat­ty liv­er dis­ease es­ti­mat­ed to af­fect mil­lions of Amer­i­cans.

Many in­vestors had nev­er heard of NASH, but with­in hours, the com­pa­ny’s shares more than tripled, adding $4 bil­lion in mar­ket val­ue and help­ing spur a half-decade of in­vest­ment in­to the field.

The road ahead, though, was rock­i­er. Pruzan­s­ki soon said they would like­ly need a part­ner to bring the drug to mar­ket — a not un­usu­al an­nounce­ment for a small biotech but one that dispir­it­ed in­vestors. Then in 2017, the com­pa­ny’s NASH com­pound, which had been ap­proved for a dif­fer­ent con­di­tion, was linked to 19 deaths. Pruzan­s­ki down­played it, say­ing doc­tors would learn how to bet­ter pre­scribe it.

Last year, In­ter­cept an­nounced much-an­tic­i­pat­ed Phase III re­sults for the NASH drug. The com­pa­ny tout­ed it as a suc­cess but the re­sults were mixed: The com­pa­ny showed the drug im­proved liv­er fi­bro­sis but failed to show that it re­solved NASH. In June, af­ter sev­er­al de­lays, the FDA re­ject­ed the com­pa­ny’s ap­proval re­quest.

Pruzan­s­ki is­sued a strong­ly word­ed state­ment, ac­cus­ing the FDA of un­fair­ly rais­ing the bar for ap­proval and for con­duct­ing an “ap­par­ent­ly in­com­plete re­view.”

“At no point dur­ing the re­view did the FDA com­mu­ni­cate that OCA was not ap­prov­able on an ac­cel­er­at­ed ba­sis,” he said.

An­oth­er blow came in the fall, af­ter the FDA flagged more po­ten­tial safe­ty is­sues with the drug. In­ter­cept on­ly dis­closed the drug on the 57th page of a quar­ter­ly re­port, in three sen­tences added to a pre-ex­ist­ing risk-state­ment para­graph.

In­ter­cept and its new CEO now find it­self in a sim­i­lar po­si­tion to much of the NASH field, which has seen mul­ti­ple late-stage tri­al fail­ures and per­sis­tent set­backs. The FDA has asked the com­pa­ny for more safe­ty and ef­fi­ca­cy da­ta.

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.

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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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.

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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.

Christophe Bourdon, Leo Pharma CEO

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As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

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

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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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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

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

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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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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.