From Agios to De­ci­phera, Steve Ho­ert­er plots an­oth­er on­col­o­gy launch; Roche ex­ec Chris­tiane Hamachar moves to In­dia as CEO of Bio­con Bi­o­log­ics

De­ci­phera $DCPH has scooped Agios’ chief com­mer­cial of­fi­cer Steve Ho­ert­er to fill re­tir­ing CEO Michael Tay­lor’s shoes. The Waltham, MA-based biotech is plac­ing its trust in Ho­ert­er’s sales acu­men, es­pe­cial­ly for can­cer drugs, ac­quired through­out his ca­reer at com­pa­nies like Clo­vis, Roche, Genen­tech, Ch­i­ron, and Eli Lil­ly. The first Phase III tri­al of ripretinib, in gas­troin­testi­nal tu­mors, is due to read out soon.

→ Japan’s Sum­it­o­mo Dainip­pon Phar­ma has tapped clin­i­cal de­vel­op­ment chief Antony Loebel to helm its Marl­bor­ough, MA-based sub­sidiary Sunovion. Loebel takes over the CEO job from Nobuhiko Tamu­ra, who presided over the com­pa­ny for five years, with the last two marked by a cou­ple of FDA re­jec­tions. Fol­low­ing a stint at Pfiz­er, Loebel joined the com­pa­ny in 2007 and has played a cen­tral role in its R&D work on psy­chi­a­try, neu­rol­o­gy and res­pi­ra­to­ry con­di­tions.

→ As An­tho­ny Zook re­tires from In­no­coll Hold­ings, the spe­cial­ty phar­ma has pro­mot­ed its chief com­mer­cial of­fi­cer and BD head to the CEO post. As­traZeneca vet Richard Fante as­sumes the top role amid the com­pa­ny’s on­go­ing ef­fort to make a come­back on its pain ther­a­pies af­ter get­ting ac­quired by Gur­net Point Cap­i­tal.

→ Hav­ing man­aged phar­ma op­er­a­tions around the world first for Scher­ing and then Roche, Chris­tiane Hamachar is mak­ing In­dia her next stop. As CEO of Bio­con Bi­o­log­ics, Hamachar will over­see the com­pa­ny’s grow­ing busi­ness in biosim­i­lars, with eyes to groom­ing a ma­jor glob­al play­er, said Bio­con chief Ki­ran Mazum­dar-Shaw.

→ Prep­ping for a Phase IIb study set to be­gin lat­er this year, No­varemed has ap­point­ed Nicholas Draeger as CEO. Af­ter found­ing and lead­ing the com­pa­ny for more than 10 years — through a move from Is­rael to Switzer­landEli Ka­plan is tran­si­tion­ing to a sup­port­ive role re­gard­ing the de­vel­op­ment of its lead drug for di­a­bet­ic neu­ro­path­ic pain. The ap­point­ment marks a re­turn to biotech for Draeger, who spent the ear­ly days of his ca­reer at Roche and lat­er got in­to health­care in­vest­ing but has been run­ning a processed food com­pa­ny.

Alessan­dro Ri­va, who joined Gilead just a lit­tle more than 2 years ago, left his post as ex­ec­u­tive vice pres­i­dent of on­col­o­gy “to pur­sue an­oth­er op­por­tu­ni­ty.” Min­utes af­ter that news hit, it was re­vealed that Ri­va is shift­ing over to lead the new biotech spin­off from In­dia’s Glen­mark, which will be based in the US. Ri­va will be CEO of the sub­sidiary com­pa­ny, which will have its own board and be heav­i­ly fo­cused on on­col­o­gy and T cells, with “five clin­i­cal and three pre­clin­i­cal as­sets in de­vel­op­ment, three clin­i­cal as­sets cur­rent­ly in Phase 2b, and one as­set like­ly to en­ter Phase 2b in FY20.”

→ South San Fran­cis­co-based Am­phive­na Ther­a­peu­tics has wooed Ar­mo founder Pe­ter Van Vlas­se­laer to be its ex­ec­u­tive chair­man while tap­ping Vic­to­ria Smith to lead its T cell en­gager re­search as CSO. Jump­ing from a se­nior role in Gilead’s bi­o­log­ics and tar­get bi­ol­o­gy group, Smith brings a trans­la­tion­al back­ground in tar­get­ed can­cer ther­a­peu­tics that fits Am­phive­na’s bill of im­muno-on­col­o­gy drugs treat­ing myeloid ma­lig­nan­cies and sol­id tu­mors.

→ A year af­ter rais­ing a mod­est Se­ries A to de­vel­op its pre­dic­tive an­a­lyt­ics tech for drug dis­cov­ery, Owkin has brought in more high pro­file in­vestors and a new chief busi­ness of­fi­cer. Most re­cent­ly, Park­er Moss was en­tre­pre­neur-in-res­i­dence at F-Prime Cap­i­tal and Eight Roads, the two lead­ers in the un­spec­i­fied ven­ture round. Moss’ main re­spon­si­bil­i­ty is to “strength­en Owkin’s part­ner­ships with hos­pi­tals, aca­d­e­m­ic cen­ters, and phar­ma­ceu­ti­cal and biotech com­pa­nies” by chan­nel­ing his ex­pe­ri­ence as a se­nior ex­ec at the NHS, ac­cord­ing to Owkin. Bruno St­rig­i­ni, No­var­tis’ for­mer head of on­col­o­gy, has joined as chair­man of the board.

→ Ra­dio­ther­a­peu­tics de­vel­op­er Fu­sion Phar­ma­ceu­ti­cals has named John J. Crow­ley (not to be con­fused with Am­i­cus’ John F. Crow­ley) its CFO, tasked with sup­port­ing “ag­gres­sive growth” as the biotech march­es in­to the clin­ic. En­gi­neered to de­liv­er al­pha par­ti­cles to can­cer cells, its lead drug, FPI-1434, con­sists of an an­ti­body di­rect­ed to­ward the in­sulin-like growth fac­tor-1 re­cep­tor 1 (IGF-1R) and an ac­tini­um-225.

Troy Ignelzi is the new CFO at Karuna, work­ing with Steve Paul to man­age the start­up biotech’s big bet on cen­tral ner­vous sys­tem dis­or­ders with KarXT. The sea­soned ex­ec is joined by Ja­son Park­er Brown, pre­vi­ous­ly of PureTech Health, who’s been hired as VP of fi­nance.

Abzena has re­cruit­ed con­tract man­u­fac­tur­ing ex­pert Elaine Sapinoso as SVP of glob­al qual­i­ty to sup­port an ex­pan­sion of its sites in San Diego and Bris­tol, PA, as well as the part­ner­ships with its bio­phar­ma clients.

→ Af­ter spend­ing 12 years in strat­e­gy con­sult­ing and in­vest­ment bank­ing, Anne Moore is mak­ing the leap to in­dus­try with the CAR-T en­gi­neers at Celyad. Of­fi­cial­ly the VP of cor­po­rate strat­e­gy, Moore will be based in the biotech’s $CYAD head­quar­ters in Bel­gium.

→ Den­mark’s LEO Phar­ma is beef­ing up its in­no­va­tion unit in Boston by hir­ing Vladimir Mo­ro­zov, Shire’s bioin­for­mat­ics so­lu­tion ar­chi­tect, as se­nior di­rec­tor of bioin­for­mat­ics. At LEO Sci­ence & Tech Hub, he will iden­ti­fy and run col­lab­o­ra­tors while dri­ving bio­mark­er de­vel­op­ment for LEO’s der­ma­to­log­i­cal meds.

Kiadis Phar­ma is gear­ing up to launch its blood can­cer drug, and it’s get­ting its ex­ec team ready for it. Cur­rent head of sup­ply chain Dirk de Naey­er, who jumped to the Am­s­ter­dam biotech from Janssen late last year, is get­ting a swift pro­mo­tion to COO. He suc­ceeds Jan Fei­jen. Mar­tine Nolan has al­so joined as head of qual­i­ty as­sur­ance.

Ve­r­ana Health has en­list­ed sev­er­al bio­phar­ma ex­ecs for its quest to ac­cel­er­ate med­ical re­search by as­sem­bling “the largest clin­i­cal data­bas­es in med­i­cine.” Hyl­ton Kalvaria, Flat­iron’s West Coast chief, comes on as VP of strate­gic part­ner­ships; Ron Cantrell is prin­ci­pal da­ta sci­en­tist, the same role he held in Genen­tech; head of prod­uct Karim Damji joins from clin­i­cal da­ta an­a­lyt­ics com­pa­ny Saa­ma. Marie-Eve Piche, a vet­er­an of Gen­er­al Electrics, is the new CFO.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA.