Ad­vo­ca­cy group and for­mer an­titrust of­fi­cial look to com­ment on Il­lu­mi­na's con­tro­ver­sial Grail merg­er

As Il­lu­mi­na con­tin­ues to fight for its $7.1 bil­lion Grail buy­out, the Amer­i­can An­titrust In­sti­tute and a for­mer an­titrust of­fi­cial want to get in­volved.

William Baer

The Wash­ing­ton DC-based ad­vo­ca­cy group and William Baer, for­mer di­rec­tor of the FTC’s Bu­reau of Com­pe­ti­tion and as­sis­tant at­tor­ney gen­er­al for DOJ’s an­titrust di­vi­sion, filed a re­quest on Mon­day to sub­mit an am­i­cus or “friend of the court” brief on a pro­posed fix that would have “im­por­tant im­pli­ca­tions for the fu­ture of merg­er law and sound an­titrust en­force­ment.”

It’s the lat­est move in a long-run­ning bat­tle against Il­lu­mi­na’s at­tempt to re-ac­quire its blood test­ing spin­out Grail, which was orig­i­nal­ly launched out of Il­lu­mi­na in 2016. The FTC filed a com­plaint about the merg­er last March, ar­gu­ing that it would sti­fle in­no­va­tion for liq­uid biop­sy can­cer screen­ing tests called mul­ti-can­cer ear­ly de­tec­tion or MCED tests, be­ing de­vel­oped by Grail and sev­er­al ri­vals.

While judge Michael Chap­pell dis­missed the com­plaint in ear­ly Sep­tem­ber, EU reg­u­la­tors blocked the ac­qui­si­tion just days lat­er. The bloc not­ed that ri­val com­pa­nies re­ly on Il­lu­mi­na’s se­quenc­ing tech­nol­o­gy for their own prod­ucts.

Mar­grethe Vestager

“With this trans­ac­tion, Il­lu­mi­na would have an in­cen­tive to cut off GRAIL’s ri­vals from ac­cess­ing its tech­nol­o­gy, or oth­er­wise dis­ad­van­tage them,” Eu­ro­pean Com­mis­sion EVP Mar­grethe Vestager said in a state­ment at the time. “It is vi­tal to pre­serve com­pe­ti­tion be­tween ear­ly can­cer de­tec­tion test de­vel­op­ers at this crit­i­cal stage of de­vel­op­ment.”

Il­lu­mi­na said it would ap­peal the de­ci­sion with gen­er­al coun­sel Charles Dadswell ar­gu­ing that the merg­er is “pro-com­pet­i­tive and will ac­cel­er­ate in­no­va­tion.”

“Il­lu­mi­na can make GRAIL’s life-sav­ing mul­ti-can­cer ear­ly de­tec­tion test more avail­able, more af­ford­able, and more ac­ces­si­ble – sav­ing lives and low­er­ing health­care costs,” Dadswell said in a news re­lease.

Charles Dadswell

In dis­miss­ing the case back in Sep­tem­ber, Chap­pell ac­knowl­edged that Il­lu­mi­na is the “on­ly vi­able sup­pli­er” of next-gen se­quenc­ing plat­forms need­ed by oth­er MCED test de­vel­op­ers. How­ev­er, he al­so added that a long-term sup­ply agree­ment by Il­lu­mi­na, or Open Of­fer, pre­vents it from harm­ing Grail’s ri­vals, call­ing the FTC’s ar­gu­ments oth­er­wise “un­con­vinc­ing.”

Baer and AAI said their brief would “ad­dress the role of the merg­ing par­ties’ Open Of­fer in the Ini­tial De­ci­sion and as­pects of Judge Chap­pell’s ap­proach to ‘lit­i­gat­ing the fix.’”

Nei­ther were im­me­di­ate­ly avail­able for com­ment on Thurs­day.

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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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.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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