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.

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.

SJ Lee [File photo]

Go­ing in­side cells, Sung Joo Lee has sketched some big goals for his small — but glob­al — team of drug hunters

For a small biotech based in South Korea with a research arm in Cambridge, MA, Orum Therapeutics has sketched out some big goals aimed at developing antibodies for intracellular targets. And now they have a new $30 million round to push the work forward, aiming at a slate of currently undruggable quests.

Orum has been working on a platform tech out of Ajou University that relies on endocytosis to smuggle antibodies and their cargo inside a cell. They’ve published work in Nature that illustrates its preclinical potential in RAS mutations, and KRAS is on their list of targets. 

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Astel­las buys in­to Fre­quen­cy's re­gen­er­a­tive med strat­e­gy with a $625M al­liance on hear­ing loss

The executive team at Frequency Therapeutics never oversold the results of their maiden Phase I/II study for a new drug to rectify hearing loss. It was, they said back in April, primarily about safety and tolerability, where their drug FX-322 performed as they had hoped. 

That early glimpse of efficacy everyone searches for in their first try on humans? 

(I)mprovements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.

We don’t know exactly what that means. But whatever the details, Astellas found enough in the data to jump in with a sizable collaboration deal.

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