Pfiz­er spin­out woos Ot­su­ka vet Ray­mond Sanchez to lead CNS pipeline work; Joe An­der­son re­turns to Ar­ix helm

Ray­mond Sanchez

→ Four months af­ter plop­ping it­self down in the cen­ter of the neu­ro­sciences field with a pipeline from Pfiz­er and $350 mil­lion in launch cash from Bain Cap­i­tal, Cerev­el Ther­a­peu­tics has re­cruit­ed a sea­soned cen­tral ner­vous sys­tem drug de­vel­op­er to be­come its CMO. Ray­mond Sanchez, who jumps from Ot­su­ka, is tasked with shep­herd­ing Cerev­el’s Parkin­son’s (dopamine D1 ag­o­nist) and epilep­sy (GA­BA A pos­i­tive mod­u­la­tor) pro­grams in­to Phase III. At the Japan­ese phar­ma, Sanchez over­saw CNS work at Avanir among oth­er re­spon­si­bil­i­ties.

→ Af­ter a brief stint as chief in­vest­ment of­fi­cer, Joe An­der­son is re­turn­ing to his CEO role at biotech start­up builder Ar­ix Bio­science. The for­mer Abing­worth part­ner was first ap­point­ed to the helm in 2016, but switched his fo­cus last Sep­tem­ber to groom the in­vest­ment team and port­fo­lio — some­thing he will con­tin­ue de­vot­ing re­sources to as the Lon­don-based com­pa­ny shifts to­ward a “lean­er” or­ga­ni­za­tion. As part of the tran­si­tion, Jonathan Pea­cock will ex­change his ex­ec­u­tive chair­man badge for the non-ex­ec­u­tive ti­tle, and his for­mer deputy Christo­pher Evans will re­tire from the board.

Dar­rin Dis­ley

→ Se­r­i­al en­tre­pre­neur and for­mer Hori­zon Dis­cov­ery CEO Dar­rin Dis­ley has tak­en the chief ex­ec­u­tive role at Cell Mo­gri­fy, a Cam­bridge, Eng­land-based start­up that just scored $3.7 mil­lion seed fund­ing to pur­sue its work on di­rect cel­lu­lar con­ver­sion. “Di­rect re­pro­gram­ing be­tween ma­ture hu­man cell types” with­out go­ing through a pluripo­tent stem cell or prog­en­i­tor cell state, Dis­ley said, “is a holy grail of re­gen­er­a­tive med­i­cine and phar­ma­ceu­ti­cal ap­pli­ca­tions,” es­pe­cial­ly as the cell ther­a­py field ex­plodes. The new CEO is al­so an in­vestor in the com­pa­ny along­side Ahren In­no­va­tion Cap­i­tal and 24Hay­mar­ket.

Rachelle Jacques

Alex­ion’s Rachelle Jacques is jump­ing ship to an­oth­er rare dis­ease biotech with a big pro­mo­tion: CEO of En­zy­vant Sci­ences, which was forged out of Vivek Ra­maswamy’s pro­lif­ic shop at Roivant back in 2016. Jacques has re­placed Alvin Shih — who was ap­point­ed months af­ter the for­ma­tion of En­zy­vant — as the com­pa­ny preps for the com­mer­cial roll out of RVT-802, a re­gen­er­a­tive ther­a­py de­signed to re­con­sti­tute the im­mune sys­tem to treat pri­ma­ry im­mune de­fi­cien­cy re­sult­ing from con­gen­i­tal athymia. She pre­vi­ous­ly served as se­nior VP and glob­al fran­chise head of com­ple­ment at Alex­ion, and has al­so worked with Shire, Bax­al­ta, Bax­ter and Dow Corn­ing.

Rosa­mond Dee­gan is step­ping down as pres­i­dent and chief busi­ness of­fi­cer at Bi­cy­cle Ther­a­peu­tics, trig­ger­ing a pro­mo­tion and a new hire to fill the two po­si­tions. Lee Kalows­ki, the biotech’s CFO, will be­come pres­i­dent of its US op­er­a­tions (it has of­fices in both Cam­bridges across the At­lantic). Mean­while, Pe­ter Leone jumps from Ar­row­head Phar­ma to lead busi­ness de­vel­op­ment ef­forts for Bi­cy­cle’s bi­cyclic pep­tide plat­form.

Roche-part­nered gene ther­a­py com­pa­ny 4D Mol­e­c­u­lar Ther­a­peu­tics is stack­ing up its C-suite with a string of ap­point­ments and pro­mo­tions. Fred Ka­mal is com­ing on board as chief tech­ni­cal of­fi­cer af­ter over­see­ing qual­i­ty and reg­u­la­to­ry CMC for Avex­is as well as Juno. Au­gust Moret­ti, for­mer­ly of As­ser­tio Ther­a­peu­tics and Alexza Phar­ma­ceu­ti­cals is the new CFO. Pe­ter Fran­cis and There­sa Janke have been pro­mot­ed to chief med­ical of­fi­cer and chief op­er­at­ing of­fi­cer re­spec­tive­ly; Fran­cis is an oph­thalmic ge­net­ics ex­pert while Janke is a found­ing mem­ber of the com­pa­ny.

→ As Red­Hill Bio­phar­ma $RDHL gears up for a po­ten­tial US launch of its an­tibi­ot­ic Tal­i­cia,  it’s tapped Rick Scrug­gs as COO of its US op­er­a­tions. A board mem­ber since 2016, Scrug­gs learned the ropes of drug com­mer­cial­iza­tion at Sal­ix Phar­ma un­til Valeant bought it up. The Is­raeli biotech is plot­ting a fourth quar­ter roll­out for Tal­i­cia, which re­cent­ly re­port­ed a Phase III suc­cess in erad­i­cat­ing H. py­lori in­fec­tion.

Doug Williams has wooed a for­mer Bio­gen col­league to his start­up team at Co­di­ak Bio­Sciences. An­drea Di­Fabio has been named chief le­gal of­fi­cer, a post she al­so oc­cu­pied re­cent­ly at Biover­a­tiv (now a Sanofi sub­sidiary). Aside from her le­gal ex­per­tise, Di­Fabio is al­so ex­pect­ed to con­tribute to cor­po­rate strat­e­gy and trans­ac­tion­al dis­cus­sions, Williams said.

→ Fol­low­ing sev­er­al pacts with high pro­file part­ners on its RNAi pro­grams, Dicer­na $DR­NA is beef­ing up its lead­er­ship team. Hard­ean Ach­neck, a for­mer CMO at stem cell ther­a­py de­vel­op­er He­mo­stemix, is the new VP, head of med­ical de­vel­op­ment; Paratek alum Regi­na DeTore Paglia has been ap­point­ed as SVP of hu­man re­sources; and new head of cor­po­rate com­mu­ni­ca­tions Re­bec­ca Pe­ter­son brings two decades of ex­pe­ri­ence from the likes of Mil­len­ni­um, Alk­er­mes and Sanofi Gen­zyme.

Log­icBio Ther­a­peu­tics has re­cruit­ed Ken­neth Hut­tner from Biover­a­tiv to its ef­fort treat­ing rare dis­eases with gene edit­ing. As SVP, head of clin­i­cal de­vel­op­ment, Hut­tner will play a key role in ad­vanc­ing the com­pa­ny’s $LOGC lead pro­gram for methyl­malonic acidemia in­to the clin­ic.

→ Hav­ing lost a bid (and a for­tune) in a run for a New Jer­sey Sen­ate seat last fall, for­mer Cel­gene CEO Bob Hug­in is mak­ing a leap back in­to biotech. He is join­ing the board of Al­ler­gan $AGN at a time the com­pa­ny, un­der pres­sure from the hedge fund Ap­paloosa LP to di­vide the role of chair­man and CEO, is slow­ly thaw­ing to the idea of re­vamp­ing its lead­er­ship struc­ture. His ap­point­ment, though, has on­ly in­spired a back­lash from the ac­tivist in­vestor, which de­scribed its as “a lame at­tempt to de­flect pres­sure through to­ken mea­sures.”

Gos­samer founder Fa­heem Has­nain (of Re­cep­tos fame) is tak­ing over the board chair­man seat at Mi­rati Ther­a­peu­tics as Rod­ney Lappe re­tires from the ge­net­ics-dri­ven can­cer drug de­vel­op­er.  

Kather­ine High, co-founder and head of R&D at gene ther­a­py pi­o­neer Spark Ther­a­peu­tics, is one of two pro­posed new mem­bers join­ing the board of CRISPR Ther­a­peu­tics. The biotech, which counts it­self a fron­trun­ner in race to de­vel­op ther­a­pies with its name­sake gene edit­ing tool, has al­so in­vit­ed Biover­a­tiv CFO John Greene to be a di­rec­tor.

→ In a push to raise its pro­file glob­al­ly, Dis­cov­ery Park — a sci­ence cam­pus based in the south­east­ern part of Eng­land — has ap­point­ed Chris Broom as head of busi­ness de­vel­op­ment.

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here. Researchers noted a dose-dependent increase of plasma concentrations of the drug in an interim review of their Phase I, primarily spotlighting safety and tolerability. And Bridge has touted preclinical data they say makes this a best-in-class contender.

Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,900+ biopharma pros reading Endpoints daily — and it's free.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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).

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,900+ biopharma pros reading Endpoints daily — and it's free.