Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Bil­lion­aire Pe­ter Thiel has made sig­nif­i­cant and some­times con­tro­ver­sial push­es in­to life sci­ences over the past few years, and one of his star­tups out of Berlin has made a new ac­qui­si­tion less than two months af­ter achiev­ing uni­corn sta­tus.

ATAI Life Sci­ences pur­chased a ma­jor­i­ty stake Tues­day in Recog­ni­fy Life Sci­ences, a com­pa­ny fo­cused on de­vel­op­ing treat­ments for cog­ni­tive im­pair­ment as­so­ci­at­ed with schiz­o­phre­nia. The fi­nan­cial terms of the deal weren’t dis­closed, but the ac­qui­si­tion fol­lows up a $125 mil­lion Se­ries C in No­vem­ber co-led by Thiel, lead­ing to a post-mon­ey val­u­a­tion of about $1 bil­lion for ATAI.

Recog­ni­fy adds to ATAI’s port­fo­lio of com­pa­nies with psy­che­del­ic and non-psy­che­del­ic ap­proach­es to men­tal health dis­or­ders, in­clud­ing de­pres­sion, anx­i­ety and ad­dic­tion. Tues­day’s deal cen­ters around Recog­ni­fy’s lead pro­gram, RL-007, a small mol­e­cule that the com­pa­ny says can mod­u­late three mech­a­nisms cen­tral to learn­ing and mem­o­ry: the cholin­er­gic, NM­DA and GA­BA type B re­cep­tor sys­tems.

“We’re fo­cused on CNS and with­in CNS men­tal health in­di­ca­tions, and we’re not lim­it­ed to ad­dic­tion, de­pres­sion, anx­i­ety, but will holis­ti­cal­ly ex­plore any­thing cat­e­go­rized in the DSM-5,” ATAI CEO Flo­ri­an Brand told End­points News. “[Schiz­o­phre­nia] is very much in our wheel­house.”

Srini­vas Rao

ATAI has com­plet­ed sev­en Phase I and two Phase II stud­ies for RL-007, but the ma­jor­i­ty of these were re­lat­ed to pain in di­a­bet­ic neu­ropa­thy, CSO Srini­vas Rao told End­points News. Three of those stud­ies demon­strat­ed im­prove­ments in ver­bal learn­ing and mem­o­ry, ATAI said, in­clud­ing in a large Phase II study of sub­jects with pe­riph­er­al neu­ro­path­ic pain.

The plan go­ing for­ward, Rao said, is to try to ex­tend the re­sults seen in these ear­li­er stud­ies and see if the com­pound’s mech­a­nism can be fur­ther es­tab­lished. Recog­ni­fy had in­clud­ed sec­ondary end­points in cog­ni­tive per­for­mance in their neu­ro­path­ic pain stud­ies, in­clud­ing a chal­lenge study in healthy vol­un­teers with the mo­tion-sick­ness drug scopo­lamine, and ATAI’s goal is to pur­sue those sig­nals in an open-la­bel tri­al ex­pect­ed to launch ear­ly this year.

“We have a bio­mark­er we can use, which are these EEG pa­ra­me­ters,” Rao said. “There were par­tic­u­lar phe­nom­e­na not­ed in the scopo­lamine chal­lenge, ba­si­cal­ly that slows down the fre­quen­cies in your EEG; that’s some­thing seen in folks with schiz­o­phre­nia. So that’s one of the first things we want to see, can you ac­tu­al­ly in­crease the fre­quen­cy … which would be con­sis­tent with pro-cog­ni­tive ef­fects.”

ATAI got start­ed back in 2018 as R&D in­ter­est — and in­vestor fund­ing — in psy­che­delics picked back up to see if the field could prove fruit­ful in men­tal-health con­di­tions. The area had been large­ly aban­doned since the des­ig­na­tion of psy­che­del­ic mol­e­cules as con­trolled sub­stances in the 1970s and sub­se­quent crack­down, but a group of re­searchers has been dip­ping their toes to try to en­gi­neer new ver­sions of those com­pounds.

Tues­day’s ac­qui­si­tion comes about five months af­ter ATAI picked up Em­path­Bio, which is ad­vanc­ing a new MD­MA treat­ment for PTSD. Though that out­fit is far from the clin­ic, ATAI hopes its can­di­dates have bet­ter pro­files than those in ear­li­er re­search where sci­en­tists had to ad­min­is­ter vari­a­tions of the par­ty drug over mul­ti­ple days, in fa­cil­i­ties where pa­tients had to be su­per­vised by trained pro­fes­sion­als for hours.

Thiel, who made his for­tune from co-found­ing Pay­Pal and mak­ing the first out­side in­vest­ment in Face­book, has been busy as well. He joined a $35.4 mil­lion Se­ries B for Pep­ti­log­ics, a pep­tide drug de­sign and de­vel­op­ment biotech, in De­cem­ber, and hopped on­to the board of Eli Lil­ly part­ner Ab­Cellera one month ear­li­er.

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.

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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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.

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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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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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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