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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.