Kevin Conroy (Exact Sciences)

A month af­ter Il­lu­mi­na's big Grail buy­out, Ex­act Sci­ences scoops up liq­uid biop­sy ri­val Thrive for a rel­a­tive bar­gain

Il­lu­mi­na is go­ing to have a lot of work to do to prove Grail was worth those $8 bil­lion.

To­day, Ex­act Sci­ences an­nounced that it will ac­quire Thrive, Grail’s chief ri­val among the ear­ly can­cer de­tec­tion star­tups, for a size­able but rel­a­tive­ly mod­er­ate $2.15 bil­lion. The yawn­ing gap in part re­flects the vast dif­fer­ences in cap­i­tal that have been in­vest­ed to date in each com­pa­ny.  But both have gone toe-to-toe over the last year and a half, with Grail hav­ing pub­lished da­ta in over 50 can­cers but Thrive re­cent­ly beat­ing them to a key test for liq­uid biop­sy com­pa­nies.

In­vestors greet­ed the Thrive buy­out with more en­thu­si­asm than they did the Grail buy­out. While Il­lu­mi­na lost $8 bil­lion in mar­ket cap af­ter news of a like­ly Grail buy­out broke, Ex­act shares have surged 18% — $19 — this morn­ing.

The two liq­uid biop­sy com­pa­nies have now sold for a com­bined $10 bil­lion in a lit­tle over a month. The col­lec­tive bet re­flects a deep faith in cor­ners of the di­ag­nos­tic and se­quenc­ing worlds in the pow­er of a tech­nol­o­gy now years in the mak­ing.

The field has moved for­ward sub­stan­tial­ly since both com­pa­nies launched. In April, Thrive pub­lished re­sults in Sci­ence that showed for the first time that a blood test could help doc­tors de­tect and treat mul­ti­ple types of can­cer in oth­er­wise healthy peo­ple, hit­ting a long-await­ed mile­stone for a sci­en­tif­i­cal­ly chal­leng­ing field, where the most vo­cif­er­ous back­ers think it can even­tu­al­ly save lives and re­make on­col­o­gy.

Still, al­though they’ve been dis­cussed in the same breath for years, both Grail and Thrive have tried to down­play the ri­val­ry. Both have point­ed out that they will need to se­cure in­sur­ance cov­er­age and re­im­burse­ment for a field that does not yet ex­ist. Hav­ing mul­ti­ple tests on the mar­ket could aid in that fight. If one test fails, it could sig­nif­i­cant­ly ham­per the ef­fort.

Ex­act Sci­ences makes for a more like­ly buy­er than Il­lu­mi­na. The di­ag­nos­tic com­pa­ny is best known for Co­lo­guard, their stool-based test for col­orec­tal can­cer, and they’ve been ag­gres­sive over the last year, ac­quir­ing Ge­nom­ic Health for $2.6 bil­lion and sign­ing ad­vanced mar­ket­ing agree­ments with Pfiz­er. The com­pa­ny en­vi­sions Thrive’s even­tu­al mar­ket as worth over $25 bil­lion.

“The ac­qui­si­tion of Thrive is a gi­ant leap to­ward en­sur­ing blood-based, mul­ti-can­cer screen­ing be­comes a re­al­i­ty and even­tu­al­ly, the stan­dard of care,” CEO Kevin Con­roy said in a state­ment. “We couldn’t be more ex­cit­ed that Ex­act Sci­ences will be at the fore­front of this in­cred­i­ble op­por­tu­ni­ty to serve pa­tients.”

The deal is worth $1.7 bil­lion in up­front, paid in 65% Ex­act stock and 35% cash. An­oth­er $415 mil­lion is avail­able through in­cen­tives.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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