Ex-Gilead R&D chief Bischof­berg­er starts over as CEO of Kro­nos Bio; Sue Ma­ho­ny steps down from Lil­ly On­col­o­gy

→ Af­ter spend­ing the past 30 years be­fore the R&D mast at Gilead, ex-re­search chief Nor­bert Bischof­berg­er is start­ing over from scratch. This morn­ing, just a few weeks af­ter his for­mal de­par­ture from the head job at one of the world’s top 15 drug re­search or­ga­ni­za­tions, Bischof­berg­er is jump­ing on board at an up­start biotech with just four full-time staffers. He’s chipped in to an $18 mil­lion seed round — rough­ly 1/200th the size of this year’s R&D bud­get at Gilead — to launch Kro­nos Bio. The biotech in-li­censed a plat­form tech­nol­o­gy out of the lab of MIT pro­fes­sor An­gela Koehler fo­cused on mod­u­lat­ing tran­scrip­tion fac­tors in can­cer, with two pre­clin­i­cal pro­grams fo­cused on MYC and the red-hot an­dro­gen re­cep­tor tar­get. 

Sue Ma­ho­ny

→ Just as Eli Lil­ly $LLY is be­gin­ning to catch up in can­cer R&D, Sue Ma­ho­ny, pres­i­dent of Lil­ly On­col­o­gy, an­nounced that she is re­tir­ing from her com­pa­ny of 18 years. Hav­ing led the unit through the in­te­gra­tion of Im­Clone af­ter the $6.5 bil­lion ac­qui­si­tion in 2008, as well as the launch of sev­er­al key drugs, Ma­ho­ny re­cent­ly led the “re­fo­cus­ing of the com­pa­ny’s on­col­o­gy R&D strat­e­gy.” It’s been a quick-fire process marked by the re­cruit­ment of top in­ves­ti­ga­tor Leena Gand­hi, $1.6 bil­lion buy­out of Ar­mo Bio and a $576 mil­lion deal to ac­quire Au­r­Ka Phar­ma. The In­di­anapo­lis-based phar­ma is con­sid­er­ing in­ter­nal and ex­ter­nal can­di­dates to suc­ceed Ma­ho­ny, whom they praise for a “pas­sion for pa­tients and strong sense of pur­pose.”

J Craig Ven­ter is re­tir­ing from Hu­man Longevi­ty, the an­ti-ag­ing start­up he found­ed, sev­er­al months af­ter he grabbed the reins back from Cyn­thia Collins. He will be re­turn­ing to the J Craig Ven­ter In­sti­tute to con­tin­ue his work, he tweet­ed.

→ Af­ter ex­per­i­ment­ing with a num­ber of plat­form tech­nolo­gies, Dean Falb is lend­ing his ear­ly-stage de­vel­op­ment skills to Log­icBio Ther­a­peu­tics as its CSO. The Cam­bridge, MA-based biotech is de­vel­op­ing gene ther­a­pies with a fo­cus on rare pe­di­atric dis­eases, and the ex­ecs like Falb’s back­ground as both a sci­en­tist and an en­tre­pre­neur: Falb co-found­ed Syn­log­ic and, un­til re­cent­ly, led its ef­forts to syn­thet­i­cal­ly en­gi­neer mi­crobes for treat­ment of rare dis­ease and can­cer. Be­fore that, he spent a cou­ple of years at At­las Ven­ture guid­ing the launch of ear­ly-stage life sci­ence com­pa­nies — and that’s af­ter lead­ing dis­cov­ery of bone mor­phogenic pro­tein drugs at Stryk­er Re­gen­er­a­tive Med­i­cine. He will now be front and cen­ter as Log­icBio plans a re­search strat­e­gy for its GeneR­ide tech.

Richard Mar­shall

→ Copen­hagen-based Galec­to Biotech has tapped GSK vet Richard Mar­shall to lead its piv­ot in­to late-stage stud­ies. As CMO, Mar­shall’s is tasked with first ex­e­cut­ing a PhI­Ib study for the in­haled galectin-3 in­hibitor TD139 in id­io­path­ic pul­monary fi­bro­sis, then bring­ing oth­er can­di­dates in fi­bro­sis, in­flam­ma­tion and can­cer in­to the clin­ic. While his pre­vi­ous ex­pe­ri­ence leans on the dis­cov­ery side, Galec­to CEO be­lieves his ex­per­tise in the res­pi­ra­to­ry and fi­bro­sis field shapes him up for the job.

→ In a bizarre saga that’s still play­ing out, Rock­well Med­ical’s board has vot­ed to fire its CEO Robert Chioi­ni. But the CEO swift­ly un­fired him­self, al­leg­ing that board mem­bers may have vi­o­lat­ed fed­er­al se­cu­ri­ties laws by vot­ing him out. That’s be­cause the pur­pose of this par­tic­u­lar meet­ing was to dis­cuss al­le­ga­tions of breach­es of fidu­cia­ry du­ties, not to vote on fir­ing the CEO. “As that ac­tion was not the pur­pose of the spe­cial meet­ing, the ter­mi­na­tion of the CEO, in the opin­ion of the non-con­flict­ed in­de­pen­dent di­rec­tors, was not ef­fec­tive,” writes Chioi­ni in a let­ter to share­hold­ers. If that wasn’t enough, Rock­well Med­ical al­so fired its CFO Thomas Kle­ma, who they said was col­lud­ing with the CEO. But that’s OK, be­cause Chioi­ni al­so re­ject­ed that de­ci­sion, un­fir­ing Kle­ma short­ly af­ter via a let­ter to share­hold­ers.

→ In con­junc­tion with a $18.9 mil­lion round co-led by Ver­sant, La­va Ther­a­peu­tics has an­nounced the ap­point­ment of Paul Par­ren as ex­ec­u­tive vice pres­i­dent and head of R&D. He’s prob­a­bly best known for his time at Gen­mab, where he’s spent 16 years as head of pre­clin­i­cal de­vel­op­ment and re­search. When asked what was be­hind his move to a small start­up, Par­ren said he was up for the chal­lenge of ear­ly-stage re­search. At Nether­lands-based La­va, he will lead the de­vel­op­ment of a type of bi-spe­cif­ic an­ti­bod­ies built on a gam­ma delta T cell plat­form.

Swift Bio­sciences — a provider of li­brary prep so­lu­tions for genome se­quenc­ing — is fol­low­ing a flur­ry of ex­pan­sion ac­tiv­i­ties up with the ap­point­ment of a new CEO. Nathan Wood ar­rives just as the com­pa­ny set­tles in­to its first West Coast of­fice in San Fran­cis­co and pre­pares to move in­to brand new head­quar­ters in Ann Ar­bor. A for­mer pres­i­dent of syn­thet­ic ge­nomics com­pa­ny SGI-DNA, Wood is ex­pect­ed to ex­tend Swift’s reach to what they see as a grow­ing group of cus­tomers in need of next-gen se­quenc­ing for dis­cov­ery, re­search and analy­sis.

→ Drawn to Trans­late Bio’s mR­NA plat­form, long­time health­care in­vestor and for­mer Al­lianz an­a­lyst John Schroer is mak­ing the jump to biotech and tak­ing up a CFO role. The young biotech be­lieves its plat­form, which tar­gets pro­tein pro­duc­tion, can be ap­plied to a broad range of dis­eases; it’s start­ing out with a clin­ic-ready pro­gram in cys­tic fi­bro­sis and an­oth­er pre­clin­i­cal drug for or­nithine tran­scar­bamy­lase de­fi­cien­cy.

→ Still reel­ing from a cru­cial Phase IIb fail­ure that dragged its stock down two months ago, Pro­tag­o­nist Ther­a­peu­tics $PT­GX has brought in Jazz Phar­ma found­ing CEO Samuel Saks to of­fer strate­gic over­sight of its pipeline. In the new­ly cre­at­ed role of chief de­vel­op­ment of­fi­cer — a po­si­tion he’s pre­vi­ous­ly tak­en up at Aus­pex Phar­ma — Saks is tasked with help­ing “re­al­ize the full po­ten­tial” of Pro­tag­o­nist’s pep­tide-based drugs by ad­vis­ing on re­search and clin­i­cal pro­grams.

→ Af­ter a clin­i­cal strat­e­gy stint at Roivant Sci­ences (pre­ced­ed by an­oth­er at Ax­o­vant), Mark Demi­track is join­ing Treve­na $TRVN as CMO. It’s a role that he’s well fa­mil­iar with, giv­en his 13-year tenure at med­ical de­vice com­pa­ny Neu­ro­net­ics. While the Chester­brook, PA-based biotech is fo­cused on pain treat­ment at the mo­ment — with an NDA for oliceri­dine in­jec­tion un­der re­view — Demi­track will be re­spon­si­ble for more than just ap­proval and post-ap­proval ac­tiv­i­ties. Chan­nel­ing his ex­pe­ri­ence at Lil­ly Re­search Labs, he will be ex­pect­ed to shep­herd Treve­na’s oth­er as­sets, in­clud­ing a treat­ment for se­vere mi­graine, from ear­ly de­vel­op­ment through com­mer­cial­iza­tion.

→ In prepa­ra­tion for the de­par­ture of CMO David Tuck, can­cer biotech Curis $CRIS has ap­point­ed Robert Martell as its first head of R&D. Martell, who’s fa­mil­iar­ized him­self with the com­pa­ny and its lead drug for dif­fuse large B-cell lym­phoma as a board mem­ber for the past few years, is now charged with putting the drug — dubbed fimepino­s­tat — on a path to reg­is­tra­tion. Martell pre­vi­ous­ly worked as CMO of Tesaro and is an ex-staffer of Bris­tol My­ers Squibb’s on­col­o­gy unit. Tuck is re­turn­ing to aca­d­e­m­ic re­search af­ter bring­ing sev­er­al of Curis’ can­di­dates in­to the clin­ic.

→ Look­ing to es­tab­lish it­self in the mar­ket for trans­la­tion­al re­search ser­vices, An­aBios has hired sea­soned ex­ec Chris Math­es as chief com­mer­cial of­fi­cer. Math­es jumps the same role at Ica­gen, which, like An­aBios, op­er­ates an ear­ly drug dis­cov­ery plat­form. Man­ag­ing the ex­ter­nal-fac­ing side of the com­pa­ny, Math­es will ex­plore busi­ness op­por­tu­ni­ties and head up strat­e­gy for its “de-risk­ing tech­nol­o­gy.”

→ On the cusp of com­mer­cial­iza­tion of its first re­gen­er­a­tive med­i­cine prod­uct, Po­lar­i­tyTE $COOL has re­cruit­ed Howard Hech­ler from med­ical equip­ment man­u­fac­tur­ing Smith & Nephew to be its chief busi­ness of­fi­cer. Hech­ler’s broad man­date spans M&A, part­ner­ing ef­forts, and align­ment of pipeline de­vel­op­ment with com­mer­cial pri­or­i­ties.

→ Re­peat en­tre­pre­neur and car­di­ol­o­gist Mar­tin Roth­man is the newest ven­ture part­ner at Sofinno­va Part­ners, the Eu­ro­pean VC firm that in­vest­ed in a com­pa­ny he found­ed called Lim­Flow. For his first for­ay in­to in­vest­ing, Roth­man will iden­ti­fy and eval­u­ate the type of com­pa­nies that he knows best: med­ical de­vice. Be­fore join­ing Sofinno­va, which closed a $340 crossover fund just weeks ago, Roth­man served as the VP of med­ical af­fairs for coro­nary, struc­tur­al heart and re­nal den­er­va­tion at med­ical de­vice gi­ant Medtron­ic.

Ar­Qule $AR­QL has en­list­ed two more ex­ecs on its quest to de­vel­op on­col­o­gy and rare dis­ease meds for bio­mark­er-de­fined pa­tient pop­u­la­tions. Marc Schegerin comes in as SVP, cor­po­rate strat­e­gy, com­mu­ni­ca­tion and fi­nance, while Shirish Hi­rani will be SVP, pro­gram man­age­ment and prod­uct plan­ning. Schegerin has split his time in bio­phar­ma be­tween in­vest­ment bank­ing and strat­e­gy roles in biotech, start­ing off at Gold­man Sachs, tak­ing stints at Bio­gen and Sage Ther­a­peu­tics be­fore land­ing at Cit­i­group most re­cent­ly. Hi­rani, on the oth­er hand, has a re­sume lined with biotechs like Dyax and Gen­zyme, topped with a drug de­vel­op­ment role at Take­da-ac­quired Ari­ad Phar­ma.

→ For­mer Deutsche Bank and UBS an­a­lyst An­drew Pe­ters is the new (and first) VP of strat­e­gy at Ex­elix­is $EX­EL. Pe­ters’ ar­rival comes on the heels of a dam­ag­ing tri­al read­out that sug­gest­ed Ex­elix­is’ MEK in­hibitor Cotel­lic wasn’t any good at boost­ing Roche’s Tecen­triq in im­prov­ing over­all sur­vival for colon can­cer pa­tients, as many an­a­lysts ex­pect­ed it would. As the South San Fran­cis­co biotech maps a path for­ward, Pe­ters will as­sist the lead­er­ship team in re­fin­ing the mid- to long-term strat­e­gy.

→ Look­ing to beef up its pipeline of both in-house and li­cens­able as­sets, San Car­los, CA-based Apex­i­gen has tapped Frances Re­na Bah­jat to steer fur­ther dis­cov­ery and pre­clin­i­cal de­vel­op­ment of im­muno-on­col­o­gy as­sets based on its plat­form tech. Bah­jat jumps to this VP of dis­cov­ery re­search role from Bris­tol My­ers Squibb, which hap­pens to be part­nered with Apex­i­gen on a com­bo fea­tur­ing Op­di­vo and APX005M. She will al­so sup­port the de­vel­op­ment of the PhII drug.

→ With a string of CRO ex­ec roles un­der his belt, Pe­te Ni­eto has been named VP of busi­ness de­vel­op­ment at Pro­Scien­to, scout­ing op­por­tu­ni­ties for the San Diego-based com­pa­ny as it ex­pands its pres­ence over­seas but re­mains fo­cused on NASH, di­a­betes, obe­si­ty and re­lat­ed meta­bol­ic dis­eases. He joins from PPD.

→ An­ti­body dis­cov­ery com­pa­ny Im­muno­Pre­cise has hired Mi­crosoft vet Charles Whee­lock as chief tech­nol­o­gy of­fi­cer and Kari Graber as di­rec­tor of glob­al client ser­vices and project man­age­ment. Co­or­di­nat­ing their work will be CEO Jen­nifer Bath, who was con­cur­rent­ly in­duct­ed to the board of di­rec­tors.

Fran­cois Nad­er has tak­en a board seat at New York City-based Pre­vail Ther­a­peu­tics as the biotech ush­ers its gene ther­a­py pro­grams for Parkin­son’s and oth­er neu­rode­gen­er­a­tive dis­eases in­to the clin­ic. Nad­er is prob­a­bly best known for his tenure at NPS Phar­ma, which cul­mi­nat­ed in a $5.2 bil­lion ac­qui­si­tion by Shire.

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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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.