So­ri­ot’s $3.5B Bril­in­ta dream is dashed by yet an­oth­er big tri­al flop for As­traZeneca

As­traZeneca CEO Pas­cal So­ri­ot

Four years ago, when Pas­cal So­ri­ot stepped to the helm of the fal­ter­ing As­traZeneca, he based his turn­around plan on a vow that the phar­ma gi­ant could trans­form Bril­in­ta in­to a block­buster fran­chise, even­tu­al­ly promis­ing in­vestors $3.5 bil­lion in an­nu­al rev­enue.

Now, af­ter its sec­ond con­sec­u­tive set­back in the clin­ic this year, So­ri­ot is fi­nal­ly back­ing off that num­ber.

This time, the drug failed to demon­strate a ben­e­fit over gener­ic Plav­ix (clopi­do­grel) for pe­riph­er­al artery dis­ease. Back in March, the heart drug flopped in a large stroke study, un­able to prove that it could beat as­pirin. And So­ri­ot can chalk up those ex­pen­sive stud­ies to prov­ing Bril­in­ta’s se­ri­ous de­fi­cien­cies.

“We don’t be­lieve the goal of $3.5 bil­lion is at­tain­able. I think it would be un­re­al­is­tic to be­lieve that,” Lu­dovic Helf­gott, head of As­traZeneca’s Bril­in­ta busi­ness, told Reuters.

Bril­in­ta brought in a to­tal of $619 mil­lion last year af­ter dis­ap­point­ing an­a­lysts re­peat­ed­ly with low­er-than-ex­pect­ed quar­ter­ly rev­enue.

Lu­dovic Helf­gott, As­traZeneca

Heart stud­ies aren’t cheap. As­traZeneca re­cruit­ed 13,500 pa­tients for the EU­CLID study, and it had en­rolled close to that num­ber for the ear­li­er SOCRATES tri­al.

As­traZeneca has ex­pe­ri­enced a rash of se­ri­ous set­backs over the course of the year, falling be­hind where it need­ed to stride for­ward. Bro­dalum­ab proved a dis­ap­point­ment, trig­ger­ing a sale to Valeant at a dis­count. The same fate await­ed lesin­u­rad. And selume­tinib re­cent­ly failed – not for the first time – in lung can­cer.

Each set­back has spurred a fresh re­view of So­ri­ot’s 2014 promise to prod rev­enue to $45 bil­lion a year by 2023, which in­creas­ing­ly looks like a pipe dream.

The phar­ma gi­ant has made some progress on the can­cer front, but is still slow­ly ad­vanc­ing its an­ti-PD-L1 pro­gram as the fourth or fifth check­point like­ly to hit the mar­ket.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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