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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Roche un­veils three new mon­key­pox tests as cas­es rise

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.