En­tra­da picks Syn­tim­mune vet Mario Saltarel­lo as CMO; Gene ther­a­py mak­er Or­chard hires Ran Zheng as CTO

Mario Saltarel­li

En­tra­da Ther­a­peu­tics, the start­up launched by 5AM and MPM Cap­i­tal to de­vel­op ther­a­pies based on a fam­i­ly of cell-pen­e­trat­ing small cyclic pep­tides that Ohio State pro­fes­sor De­hua Pei dis­cov­ered, has found a chief med­ical of­fi­cer in Mario Saltarel­li. “His ex­pe­ri­ences at both ven­ture-backed biotech­nol­o­gy and glob­al phar­ma­ceu­ti­cal com­pa­nies have in­volved him in every as­pect of bring­ing a med­i­cine from bench to bed­side,” said CEO Di­pal Doshi, re­fer­ring to Saltarel­li’s stints at Syn­tim­mune, Ver­tex, An­nex­on and Mallinck­rodt, among oth­ers.

→ Hav­ing sharp­ened his CFO acu­men at Aldeyra and Javelin, Stephen Tuli­pano has land­ed a new job at Stoke Ther­a­peu­tics. The Bio­gen alum joins Stoke months af­ter it closed a $90 mil­lion Se­ries B bank­ing on its an­ti­sense ap­proach — up­reg­u­lat­ing pro­tein ex­pres­sion — to ge­net­ic epilep­sies and oth­er dis­eases, with a lead (pre­clin­i­cal) pro­gram in Dravet syn­drome.

→ Wrap­ping up a Phase III pro­gram for its pe­di­atric liv­er drug, Al­bireo has be­gun plan­ning for the po­ten­tial launch by cre­at­ing a chief com­mer­cial of­fi­cer role. Pamela Stephen­son, a vet­er­an of Ver­tex and Pfiz­er, will take on the po­si­tion. A4250 is de­signed to treat pro­gres­sive fa­mil­ial in­tra­hep­at­ic cholesta­sis, square­ly sit­u­at­ed in the or­phan realm in which Stephen­son has spent plen­ty of time.

→ Two months af­ter we broke the sto­ry that For­ma Ther­a­peu­tics had axed R&D staff in a ma­jor re­or­ga­ni­za­tion of the com­pa­ny, found­ing CEO Steve Tre­gay is now join­ing the ex­o­dus. He’s be­ing re­placed at the helm by Genen­tech vet and chief strat­e­gy of­fi­cer Frank Lee. Lee, whose last ti­tle at Genen­tech was se­nior vice pres­i­dent, glob­al prod­uct strat­e­gy, had a di­rect hand in launch­ing some of the big biotech’s top fran­chise drugs

Ran Zheng

→ Fol­low­ing a 16-year ca­reer han­dling op­er­a­tions at Am­gen, Ran Zheng is join­ing Or­chard Ther­a­peu­tics $OR­TX as its first chief tech­ni­cal of­fi­cer. Her re­spon­si­bil­i­ties span process de­vel­op­ment, man­u­fac­tur­ing, qual­i­ty, fa­cil­i­ties and en­gi­neer­ing, sup­ply chain, as well as CMC — all cru­cial el­e­ments in Or­chard’s quest to be­come a full-fledged de­vel­op­er of rare dis­ease gene ther­a­pies.

→ Weeks af­ter Mark Sir­go took the helm at ArunA Bio, he’s tapped Al Med­war, a for­mer col­league at BioDe­liv­ery Sci­ences, to ex­e­cute on cor­po­rate and com­mer­cial de­vel­op­ment of its ex­o­some plat­form. The Athens, GA-based com­pa­ny is wag­ing a fresh ef­fort to de­vel­op ther­a­peu­tics for neu­rode­gen­er­a­tive dis­eases us­ing neur­al ex­o­somes and could use some in­dus­try col­lab­o­ra­tions.

→ With a new CSO in place, Nim­bus Ther­a­peu­tics is beef­ing up its sci­en­tif­ic team to ac­cel­er­ate its mo­men­tum in drug dis­cov­ery. Alan Col­lis has been named VP of pre­clin­i­cal de­vel­op­ment, hav­ing worked with the com­pa­ny part-time since leav­ing the DPMK di­rec­tor role at For­ma Ther­a­peu­tics last Oc­to­ber. Jen­nifer Roc­nik, cur­rent di­rec­tor of on­col­o­gy bi­ol­o­gy, got a pro­mo­tion to VP bi­ol­o­gy.

→ As Fractyl Lab­o­ra­to­ries kicks off a clin­i­cal tri­al in type 2 di­a­betes, the Lex­ing­ton, MA-based  com­pa­ny has hired for­mer Sanofi ex­ec Mar­garet Bo­rys as chief com­mer­cial of­fi­cer and In­ter­cept alum Juan Car­los Lopez-Ta­lav­era as chief med­ical of­fi­cer. Its lead prod­uct can­di­date, Re­vi­ta DMR, is an out­pa­tient pro­ce­dure de­signed to re­ju­ve­nate the in­testi­nal lin­ing through a catheter in or­der to re­verse in­sulin-re­sis­tant meta­bol­ic dis­eases like di­a­betes and NASH.

→ Ox­ford pro­fes­sor Mark Mc­Carthy has of­fi­cial­ly hung up his “metaphor­i­cal stetho­scope” to and trav­el­ing halfway across the world to lead hu­man ge­net­ics at Genen­tech in the Bay Area. His new job will in­volve en­abling drug dis­cov­ery, as well as di­rect­ing a re­search team fo­cused on trans­la­tion­al ef­forts.

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.