Jerry Durso was promoted to CEO last month, part of a broader shakeup in Intercept's leadership

In­ter­cept shake­up con­tin­ues as CMO, for­mer NASH chief re­signs. Is the NASH biotech aban­don­ing its flag­ship dis­ease?

First, they said good­bye to their found­ing CEO af­ter 18 years. Now, In­ter­cept is los­ing its CMO too, an ex­ec­u­tive who led the com­pa­ny’s flag­ship NASH pro­gram for much of its clin­i­cal de­vel­op­ment.

In­ter­cept re­vealed in an SEC fil­ing Mon­day that Ja­son Cam­pagna ten­dered his res­ig­na­tion and will leave the com­pa­ny on March 5. His de­par­ture comes three months af­ter the com­pa­ny abrupt­ly an­nounced they were re­plac­ing long­time CEO Mark Pruzan­s­ki with COO and for­mer Sanofi com­mer­cial chief Jer­ry Dur­so.

Ja­son Cam­pagna

In­ter­cept said Cam­pagna was leav­ing for oth­er op­por­tu­ni­ties, em­pha­siz­ing there was no “dis­agree­ment re­gard­ing any mat­ter re­lat­ed to the Com­pa­ny’s op­er­a­tions, poli­cies, or prac­tices,” but an­a­lysts sug­gest­ed his de­par­ture could be part of a broad­er shift as the com­pa­ny con­tin­ues to game out its fu­ture, af­ter the FDA re­ject­ed their long-watched NASH drug last June.

Cam­pagna led the com­pa­ny’s NASH pro­gram af­ter he was hired from The Med­i­cines Com­pa­ny in 2016. His de­par­ture, along with the de­ci­sion to re­place Pruzan­s­ki with a CEO whose ex­per­tise is on com­mer­cial­iz­ing, rather than de­vel­op­ing, drugs could sig­nal that In­ter­cept thinks it will be dif­fi­cult to col­lect the NASH da­ta the FDA wants and is in­stead de­cid­ing to fo­cus on its al­ready ap­proved PBC pro­gram.

“We would ex­pect a rea­son­ably smooth tran­si­tion,” RBC Cap­i­tal’s Bri­an Abra­hams wrote to in­vestors Mon­day, not­ing that act­ing CMO Gail Cawk­wel worked close­ly with Cam­pagna. “That be­ing said… we be­lieve the com­pa­ny may be in­creas­ing­ly rec­og­niz­ing the po­ten­tial NASH reg­u­la­to­ry chal­lenges and is re­in­forc­ing the core PBC fran­chise to op­ti­mize val­ue and sus­tain­abil­i­ty, with the pos­si­bil­i­ty of a pro­longed or more oner­ous NASH path – which may be­come in­creas­ing­ly like­ly as time pro­gress­es.”

It’s enough volatil­i­ty to con­vince Abra­hams to sit “on the side­lines” un­til they give fur­ther clar­i­ty. In­ter­cept’s stock $ICPT was down 6% be­fore the bell from $29.86 to $27.91. The stock was val­ued at just over $90 a year ago.

In an email, an In­ter­cept spokesper­son de­nied that there was any shift, say­ing that they were “laser-fo­cused” on com­ing to an agree­ment with the FDA on how to re­sub­mit their NDA. He added that a read­out from an­oth­er Phase III NASH tri­al is al­so do out be­fore the end of the year.

SVB Leerink’s Thomas J. Smith, though, not­ed the com­pa­ny al­so re­cent­ly said good­bye to US com­mer­cial & strate­gic mar­ket­ing vice pres­i­dent Richard Kim and pro­mot­ed to com­mer­cial chief Lin­da Richard­son, who had pre­vi­ous­ly run their cholesta­sis pro­grams, which in­cludes PBC.

“The near and per­haps medi­um-long term fo­cus may be on max­i­miz­ing the val­ue of this rare cholesta­t­ic liv­er dis­ease fran­chise, rather than ex­pand­ing ag­gres­sive­ly in­to the broad­er NASH com­mer­cial are­na,” he told in­vestors. “While ICPT man­age­ments’ re­cent com­ments have sug­gest­ed a con­tin­ued de­sire to pur­sue NASH ap­proval pend­ing align­ment with the FDA on a path for­ward for obeti­cholic acid (OCA) NDA re­sub­mis­sion, we be­lieve some in­vestors may read these per­son­nel moves as a sig­nal of a larg­er strate­gic shift with­in ICPT away from NASH.”

In­ter­cept was one of the first com­pa­nies to bring NASH, a fat­ty liv­er dis­or­der be­lieved to af­flict more than 10 mil­lion Amer­i­cans, on­to the drug de­vel­op­ment scene, pre­sent­ing da­ta at JPM 2014 that sent their stock sky­rock­et­ing. The biotech, though, did not emerge un­scathed from the same clutch of clin­i­cal fail­ures that sub­se­quent­ly plagued a se­ries of small biotechs and larg­er com­pa­nies such as Gilead.

In 2019, their Phase III tri­al pro­duced mixed re­sults, hit­ting on one pri­ma­ry end­point re­lat­ed to fi­bro­sis but miss­ing the pri­ma­ry end­point around NASH it­self. They be­lieved that was enough for ap­proval, and Pruzan­s­ki lashed out at the FDA when their de­ci­sion came over a year lat­er, ac­cus­ing the agency of mov­ing the goal­posts.

In­ter­cept has op­tions out­side of NASH. The same drug they were try­ing to get ap­proved for the block­buster in­di­ca­tion is al­ready ap­proved for PBC, or pri­ma­ry bil­iary cholan­gi­tis, an au­toim­mune dis­ease that af­fects the liv­er. The pipeline be­yond those two in­di­ca­tions, how­ev­er, is most­ly bare.

At their Q3 ear­ings, the com­pa­ny said they were in the midst of down­siz­ing to max­i­mize their PBC busi­ness, which grossed $80 mil­lion that quar­ter, and were still in dis­cus­sions with the FDA over NASH. An­oth­er up­date is ex­pect­ed Thurs­day, when Dur­so de­liv­ers his first an­nu­al re­port.

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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