Il­lic­it drugs are mak­ing some big ad­vances in R&D, and Thiel part­ners at ATAI get a $43M bankroll to fu­el dri­ve on mag­ic mush­rooms, Spe­cial K

Just a few weeks af­ter the FDA of­fered phar­ma gi­ant J&J an ap­proval for its nose spray ver­sion of the par­ty drug Spe­cial K, flag­ging its will­ing­ness to low­er the gold stan­dard on drug de­vel­op­ment for a chance at adding a new ap­proach to de­pres­sion, a glob­al biotech start­up in­volved in bring­ing psy­che­del­ic med­i­cine in from the fringe just raised $43 mil­lion to build their pipeline.

Lars Wilde

ATAI Life Sci­ences is in the spot­light this morn­ing with their new round, of­fer­ing an­oth­er ex­am­ple of how some il­lic­it drugs are en­ter­ing the clin­i­cal spot­light for treat­ing psy­chi­atric con­di­tions. 

In this case, the com­pa­ny is al­so an in­vestor or own­er of two com­pa­nies that have al­ready made some progress with their lead ef­forts.

One of those com­pa­nies is Com­pass Path­ways, which be­gan test­ing psilo­cy­bin — the ac­tive in­gre­di­ent in mag­ic mush­rooms — for de­pres­sion. ATAI says it is the biggest in­vestor in Com­pass, which is re­port­ed­ly al­so backed by Pe­ter Thiel, a bil­lion­aire who’s been known to make a few con­tro­ver­sial moves in drug R&D. The biotech is run by the hus­band and wife team of George Gold­smith and Eka­te­ri­na Malievska­ia, win­ning a break­through ther­a­py des­ig­na­tion from the FDA that has helped le­git­imize its work.

Thiel isn’t the on­ly con­tro­ver­sial high roller in the game. Ex-hedge fund man­ag­er and cur­rent cryp­tocur­ren­cy ex­ec Mike Novo­gratz is al­so cred­it­ed as a backer of ATAI.

Im­age: George Gold­smith and Eka­te­ri­na Malievska­ia. COM­PASS

Com­pass be­gan re­cruit­ing healthy vol­un­teers for a study in Lon­don last sum­mer, at­tract­ing wide at­ten­tion for their work in­volv­ing a psy­che­del­ic drug with a col­or­ful his­to­ry of il­lic­it use around the world. The FDA ap­proved a Phase IIb last year as well.

“Our goal from the very be­gin­ning has been to find an ef­fec­tive treat­ment and make it avail­able through the health sys­tem to peo­ple who would nev­er take some­thing il­le­gal,” Malievska­ia told the Fi­nan­cial Times last year, say­ing she was mo­ti­vat­ed by her son, who suf­fers from se­vere de­pres­sion.

Flo­ri­an Brand

ATAI co-founder Lars Wilde is al­so COO and co-founder of Com­pass, while Flo­ri­an Brand’s CV lists his role as in­ter­im CEO at Per­cep­tion Neu­ro­science, which ATAI bought out in Jan­u­ary. Per­cep­tion has been work­ing on ar­ke­t­a­mine, its own for­mu­la­tion of the par­ty drug and horse tran­quil­iz­er ke­t­a­mine, bet­ter known in cer­tain cir­cles as Spe­cial K. 

J&J’s ri­val es­ke­t­a­mine made drug his­to­ry ear­li­er this month when the FDA ap­proved it, de­spite fail­ing a cou­ple of stud­ies and falling short of a clear gold stan­dard re­quir­ing pos­i­tive da­ta from two well-con­trolled drug tri­als for an ap­proval — a stan­dard that has de­feat­ed re­peat­ed Phase III at­tempts. Ke­t­a­mine has been in dozens of aca­d­e­m­ic stud­ies, with a proven abil­i­ty to pro­vide fast re­lief for many se­vere­ly de­pressed pa­tients. And see­ing the FDA green light the NM­DA ther­a­py for mar­ket­ing has fo­cused more at­ten­tion on the role that il­le­gal drugs can play in treat­ing psy­chi­atric con­di­tions.

Chris­t­ian Anger­may­er

ATAI’s co-founders have tout­ed an­i­mal da­ta which they say il­lus­trate their drug’s su­pe­ri­or­i­ty to es­ke­t­a­mine, a du­bi­ous strat­e­gy in the es­tab­lished R&D world. They al­so say it beat ra­pastinel, which re­cent­ly flunked a Phase III pro­gram at Al­ler­gan.

Chris­t­ian Anger­may­er, who counts him­self as a co-founder of Al­ny­lam, rounds out the founders club at ATAI.

J&J may have helped blaze the trail. But they’re al­so a glob­al play­er with a big bankroll for R&D. ATAI will now start test­ing whether oth­ers can start go­ing down the same path, with­out the big bucks and in­dus­try rep J&J has.

Michael Auer­bach’s New York-based Sub­ver­sive Cap­i­tal led the round, with Ape­iron In­vest­ment Group, Bail Cap­i­tal, and Efrem Ka­men, founder of Pu­ra Vi­da In­vest­ments jump­ing in.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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