What’s up with all the buzz about Gilead’s PhI­II NASH drug selon­sert­ib?

Ear­li­er Wednes­day we could de­tect a dis­tinct dis­tur­bance in the biotech force as some care­ful stu­dents of clin­i­cal­tri­als.gov picked up on some ma­jor — and re­cent­ly filed — changes in the time­lines list­ed for a read­out on Gilead’s $GILD close­ly-watched NASH drug selon­sert­ib.

STEL­LAR 4, their Phase III study for com­pen­sat­ed cir­rho­sis due to NASH, and STEL­LAR 3, on ad­vanced NASH and bridg­ing F3 fi­bro­sis, had been giv­en near-term planned com­ple­tion dates that lined up with Gilead’s re­peat­ed­ly con­firmed plans to post the ini­tial re­sults in Q1 and Q2. But the Jan­u­ary and March com­ple­tion dates were rad­i­cal­ly ad­just­ed, just days ago, to No­vem­ber, 2022 and Feb­ru­ary, 2023.

Eye­brows were quick­ly raised.

The time­lines on this drug are cru­cial to the com­pa­ny’s nar­ra­tive as CEO John Mil­li­gan and Chair­man John Mar­tin head for the ex­its, with Roche’s Daniel O’Day com­ing in to take the helm. And the da­ta are due as In­ter­cept lines up ri­val late-stage da­ta of its own.

A spokesman for Gilead, though, says that the in­ter­im read­outs are still on tap for the first half, as an­a­lysts are ea­ger­ly an­tic­i­pat­ing.

Here’s the state­ment I got from Gilead Wednes­day af­ter­noon, right af­ter the clos­ing bell:

STEL­LAR 3 and 4 are phase 3 ran­dom­ized, dou­ble-blind, place­bo-con­trolled tri­als in­ves­ti­gat­ing the safe­ty and ef­fi­ca­cy of Selon­sert­ib in adults with non­al­co­holic steato­hep­ati­tis (NASH) with F3 bridg­ing fi­bro­sis or F4 cir­rho­sis, re­spec­tive­ly. The in­ter­im analy­ses of these tri­als at 48 weeks are ex­pect­ed to read out in the first half of 2019. The tri­al com­ple­tion da­ta at 240 weeks du­ra­tion is ex­pect­ed to com­plete in No­vem­ber 2022 for the STEL­LAR 4 tri­al and Feb­ru­ary 2023 for the STEL­LAR 3 tri­al.

Clin­i­cal tri­als.gov was re­cent­ly up­dat­ed to re­flect 240 weeks as the pri­ma­ry com­ple­tion dates of both STEL­LAR tri­als.

Jef­feries’ Michael Yee is on watch du­ty, not­ing a cou­ple of weeks ago that these read­outs pose a sig­nif­i­cant cat­a­lyst for the com­pa­ny’s stock.

Man­age­ment re­mains con­fi­dent and “op­ti­mistic” about Phase III selon­sert­ib, though they ac­knowl­edge odds are stacked against them.

This is one of the most care­ful­ly tracked da­ta re­leas­es of 2019. So we’ll be there on the watch with him.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.