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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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