Cel­lec­tis re­cruits ex-Servi­er re­search chief De­pil; Are­na inks $224M deal on new drugs; JLABS heads to Shang­hai; As­traZeneca vet takes Goldfinch helm

→ French CAR-T de­vel­op­er Cel­lec­tis has re­cruit­ed Stéphane De­pil, the for­mer R&D chief of Servi­er, to lead the com­pa­ny’s clin­i­cal de­vel­op­ment. De­pil will serve as se­nior vice pres­i­dent of R&D and chief med­ical of­fi­cer. The new ap­point­ment brings De­pil back to the in­dus­try af­ter a break while he di­rect­ed the can­cer im­munother­a­py pro­gram at the Léon Bérard Can­cer Cen­ter in Ly­on, France. But back when he was at Servi­er, he over­saw 20 can­cer pro­grams, sev­er­al of which were in clin­i­cal tri­als. Cel­lec­tis hopes to ben­e­fit from De­pil’s track record in the field to move its CAR-T as­sets in­to the clin­ic af­ter a rough start in­volv­ing a pa­tient death. “Stéphane De­pil’s deep med­ical, aca­d­e­m­ic, and clin­i­cal reg­u­la­to­ry on­col­o­gy ex­pe­ri­ence – specif­i­cal­ly in R&D for all phas­es with­in the phar­ma­ceu­ti­cal, biotech­nol­o­gy, and clin­i­cal re­search spaces – will be in­valu­able as he leads Cel­lec­tis’ strat­e­gy and pro­motes aware­ness of the break­through work that we are do­ing as a leader and in­no­va­tor in the gene-edit­ing field,” said An­dré Chouli­ka, Cel­lec­tis’ CEO, in a state­ment. “His strate­gic al­liance-build­ing, col­lab­o­ra­tion skills, un­der­stand­ing of the glob­al en­vi­ron­ment with on­co­log­i­cal clin­i­cal re­search, and first­hand ex­pe­ri­ence run­ning a phar­ma com­pa­ny all add a great de­gree of abil­i­ty and depth to our lead­er­ship team.”

→ Are­na Phar­ma­ceu­ti­cals, the San Diego drug mak­er best known for its di­et pill Belviq, has inked a deal worth up to $224M with Ever­est Med­i­cines to de­vel­op and com­mer­cial­ize its two new pipeline drugs in main­land Chi­na, Tai­wan, Hong Kong, Macau, and South Ko­rea. The two drugs, ra­linepag and es­trasi­mod, are a far cry from Are­na’s ear­ly work in obe­si­ty drugs. Ra­linepag is a Phase III-ready oral, se­lec­tive prosta­cy­clin re­cep­tor ag­o­nist for the treat­ment of pul­monary ar­te­r­i­al hy­per­ten­sion. The drug’s Phase II da­ta got Are­na’s in­vestors pret­ty jazzed ear­li­er this year. The drug is de­signed to be more po­tent and ef­fec­tive than Acte­lion’s Up­travi. Then there’s etrasi­mod, a Phase II oral S1P re­cep­tor mod­u­la­tor be­ing eval­u­at­ed for mul­ti­ple au­toim­mune dis­eases, in­clud­ing ul­cer­a­tive col­i­tis, a form of in­flam­ma­to­ry bow­el dis­ease. Ear­li­er this year, Amit Mun­shi said the drug was safer and po­ten­tial­ly more ef­fi­ca­cious than Ozan­i­mod, the drug de­vel­oped by San Diego’s Re­cep­tos (pur­chased by Cel­gene for $7.2 bil­lion). In the new deal with Ever­est, a com­pa­ny backed by $50M from Chi­na’s C-Bridge Cap­i­tal, Are­na gets $12M in an up­front pay­ment and is el­i­gi­ble to re­ceive up to $212M in mile­stones, along with roy­al­ties.

John­son & John­son is launch­ing a JLABS in Shang­hai — the first lo­ca­tion out­side of North Amer­i­ca — af­ter reach­ing agree­ments with the Shang­hai Mu­nic­i­pal Gov­ern­ment, Pudong New Area Gov­ern­ment and Shang­hai Phar­ma En­gine Com­pa­ny. Sched­uled to open in Q2 2019, the fa­cil­i­ty in Zhangjiang Hi-Tech Park will span 4,400 sq. me­ter (47,000+ sq. ft.) and can host up to 50 life sci­ence and health care star­tups. “Chi­na, and Shang­hai specif­i­cal­ly, have be­come a glob­al hotspot for health­care in­no­va­tion,” said Vladimir Makat­saria, John­son & John­son Chi­na Group chair­man, in a state­ment. J&J is cur­rent­ly ac­cept­ing ap­pli­ca­tions from biotech, phar­ma­ceu­ti­cal, med­ical de­vice, con­sumer and dig­i­tal health com­pa­nies to this site as well as its eight oth­er JLABS lo­ca­tions.

→ In­dus­try vet An­tho­ny John­son is tak­ing the helm at Goldfinch Bio, a Cam­bridge, MA-based biotech look­ing to de­vel­op new drugs for ge­net­i­cal­ly de­fined kid­ney dis­eases. Goldfinch launched a year ago with $55 mil­lion in Third Rock mon­ey. John­son is the lat­est in a long line of Big Phar­ma R&D ex­ecs mak­ing a move to a start­up, leav­ing his post as head of ear­ly clin­i­cal de­vel­op­ment for the In­no­v­a­tive Med­i­cines and Ear­ly De­vel­op­ment Biotech Unit. His bio in­cludes 25 pos­i­tive proof-of-con­cept stud­ies. In ad­di­tion, Michael Brox­son is join­ing Goldfinch as chief busi­ness and op­er­at­ing of­fi­cer.

Shire $SH­PG has struck a col­lab­o­ra­tion deal with Rani Ther­a­peu­tics that gives the rare dis­ease gi­ant ex­clu­sive rights to re­search, eval­u­ate and pur­sue a world­wide li­cense for the oral de­liv­ery of fac­tor VI­II to pa­tients with he­mo­phil­ia A. This in­vest­ment, the terms of which were not dis­closed, comes just a few weeks af­ter ri­val Roche’s Hem­li­bra nabbed an FDA ap­proval, some­thing that an­a­lysts said could help shrink Shire’s share of the he­mo­phil­ia mar­ket from 49% to 29%. The Rani Pill tech­nol­o­gy brings a nov­el in­testi­nal de­liv­ery ap­proach to the treat­ment of he­mo­phil­ia, which is dom­i­nat­ed by in­jecta­bles, though the com­pa­ny is al­so do­ing work on rheuma­toid arthri­tis, can­cer and Crohn’s dis­ease. As part of the pact, Shire has al­so made an eq­ui­ty in­vest­ment in­to Rani Ther­a­peu­tics.

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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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.

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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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.