A block­buster cock­tail? Gilead slides No­vo Nordisk's semaglu­tide in­to new NASH triple ther­a­py

In case you didn’t get the memo, Gilead is bet­ting that a cock­tail ap­proach will win them a cov­et­ed place in the NASH show­down.

A day af­ter draw­ing at­ten­tion to pos­i­tive proof-of-con­cept da­ta around its cilofex­or/fir­so­co­stat ther­a­py, the Big Biotech says it’s kick­ing off an­oth­er clin­i­cal tri­al in col­lab­o­ra­tion with No­vo Nordisk in which semaglu­tide will be added to form a three-drug reg­i­men.

A block­buster fa­vorite among up-and-com­ing di­a­betes drugs, semaglu­tide is a GLP-1 ana­logue that not on­ly stim­u­lates se­cre­tion of in­sulin but al­so is thought to im­prove glu­cose me­tab­o­lism in the liv­er and in­crease fat­ty acid ox­i­da­tion. Giv­en that more than 40% of NASH pa­tients have di­a­betes and more than 80% of them are al­so liv­ing with obe­si­ty (No­vo Nordisk’s num­bers) — an­oth­er tar­get in­di­ca­tion for semaglu­tide — the Dan­ish drug­mak­er has called its in­ter­est in the dis­ease a “nat­ur­al ex­pan­sion.”

For Gilead, this will be an op­por­tu­ni­ty to for­ti­fy a grow­ing NASH port­fo­lio as well as flex its sci­en­tif­ic mus­cles. The part­ner­ship al­so cov­ers a po­ten­tial col­lab­o­ra­tion on pre­clin­i­cal re­search to bet­ter un­der­stand an ail­ment of­ten dubbed a silent dis­ease.

With car­diopul­monary sales wan­ing — caused by loom­ing gener­ic en­try and il­lus­trat­ed by a round of lay­offs an­nounced this week — the hep C op­er­a­tions shrink­ing, HIV un­der as­sault and the bold new CAR-T ven­ture slow to im­press, Gilead is pressed to find a new area in which it can es­tab­lish as for­mi­da­ble a pres­ence as it had in the an­tivi­ral realm.

It took a hit when selon­sert­ib flopped in a close­ly-watched Phase III, out­per­formed by the place­bo at the low dose, dash­ing hopes for a vault to the lead po­si­tion as a flock of small play­ers take turns to present their own late-stage re­sults.

As ri­vals — in­clud­ing In­ter­cept, Gen­fit, Madri­gal and NGM Bio, which is part­nered with Mer­ck — crowd in, Gilead has been pick­ing up ear­ly-stage as­sets in pur­suit of a sus­tain­ing fran­chise. In fact, cilofex­or came from the buy­out of Phenex Phar­ma and you might re­mem­ber fir­so­co­stat as GS-0976, which Gilead paid Nim­bus $600 mil­lion for.

The com­pa­ny al­so hasn’t giv­en up on selon­sert­ib, which is be­ing test­ed in a triple com­bo with cilofex­or and fir­so­co­stat.


Im­age: Er­ic Ris­berg AP

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.