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.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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