Mor­phoSys taps Baven­cio lead for US op­er­a­tions; Two top FDA of­fi­cials move to in­dus­try

→ Hav­ing built out a com­mer­cial foot­print in the US and led the launch of Baven­cio for Mer­ck KGaA, David Trexler is tak­ing up a new role as pres­i­dent of Ger­man biotech Mor­phosys’ US sub­sidiary. Fol­low­ing a dual list­ing on the Nas­daq $MOR last year, Mor­phoSys is plot­ting a swift roll­out for MOR208 once the FDA ap­proves its use in dif­fuse large B cell lym­phoma — now with a guid­ing hand from Trexler, who’s al­so worked sales and mar­ket­ing for Ei­sai’s US on­col­o­gy unit.

Michelle Berrey — the woman who re­placed Chimerix CEO Ken­neth Moch in 2014 af­ter the com­pa­ny no­to­ri­ous­ly de­nied a dy­ing child com­pas­sion­ate use of its ex­per­i­men­tal treat­ment — has stepped down for undis­closed rea­sons. Berrey, who served as the com­pa­ny’s chief med­ical of­fi­cer pri­or to be­com­ing CEO, steered the ship at Chimerix as the Durham, North Car­oli­na-based com­pa­ny sought to spin set­back af­ter set­back in the late-stage de­vel­op­men­tal pro­gram of its oral an­tivi­ral drug, brin­cid­o­fovir, for the pre­ven­tion of cy­tomegalovirus (CMV) dis­ease in kid­ney trans­plant pa­tients.

Michelle Berrey

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Chimerix said a new­ly cre­at­ed of­fice of the CEO — en­cap­su­lat­ing three se­nior ex­ec­u­tives CMO Gar­rett Nichols, CFO Tim­o­thy Trost and gen­er­al coun­sel Michael Al­rutz — will hold the fort while it search­es for Berrey’s re­place­ment.

→ Ready for a fresh round of deal­mak­ing, Cy­tomX $CT­MX has brought in Nick Gal­li from De­nali as chief busi­ness of­fi­cer. The South San Fran­cis­co biotech has tied up with sev­er­al big bio­phar­ma com­pa­nies on its Pro­body plat­form — pock­et­ing sub­stan­tial up­fronts — though Pfiz­er walked away from a pact a lit­tle less than a year ago. Gal­li, whose BD track record ex­tends to Genen­tech and John­son & John­son In­no­va­tion Cen­ter, joins the com­pa­ny at the same time as Leslie Rob­bins, the new se­nior vice pres­i­dent, in­tel­lec­tu­al prop­er­ty.   

Co­lum­bia Uni­ver­si­ty spin­out Kally­ope has tapped Brett Lau­r­ing to steer the meta­bol­ic and CNS treat­ments com­ing out of its plat­form, which is fo­cused on the bi-di­rec­tion­al com­mu­ni­ca­tion known as the “gut-brain ax­is.” Be­tween a stint as Take­da’s VP of trans­la­tion­al re­search and 11 years of clin­i­cal de­vel­op­ment at Mer­ck, Lau­r­ing brings the whole pack­age to Kally­ope’s dis­cov­ery pro­grams, the com­pa­ny said.

Kyn Ther­a­peu­tics has re­cruit­ed a new CFO in Dou­glas Carl­son just days af­ter scor­ing $80 mil­lion up­front in an op­tion deal with Cel­gene. Carl­son joins the Boston-based biotech, which is go­ing af­ter metabo­lites that keep the im­mune sys­tem from at­tack­ing can­cer, from spe­cial­ty pain man­age­ment com­pa­ny Col­legium Phar­ma­ceu­ti­cal.  

→ Still reel­ing from the dis­ap­point­ing ter­mi­na­tion of an Alzheimer’s tri­al part­nered with Roche, AC Im­mune $ACIU is now in­tent on hus­tling its pre­clin­i­cal and clin­i­cal pro­grams to lat­er stage de­vel­op­ment as quick­ly as pos­si­ble. The Swiss biotech is pro­mot­ing Pier­gior­gio Do­nati­joins to head of tech­ni­cal op­er­a­tions and tap­ping So­nia Poli, pre­vi­ous­ly CSO at Ad­dex Ther­a­peu­tics, as head of trans­la­tion­al sci­ence, cov­er­ing all fronts on man­u­fac­tur­ing, pro­gram co­or­di­na­tion and tran­si­tion from dis­cov­ery to pre­clin­i­cal work.

Erkan Baloglu has joined an­ti-ag­ing biotech resTOR­bio as VP of drug dis­cov­ery and med­i­c­i­nal chem­istry af­ter a string of sim­i­lar roles at Karyopharm Ther­a­peu­tics, Glax­o­SmithK­line and Im­muno­Gen, among oth­ers. The com­pa­ny is plan­ning to test its TORC1 in­hibitor in uri­nary tract in­fec­tions, heart fail­ure with pre­served ejec­tion frac­tion and oth­er undis­closed dis­eases.

Clin­i­gen has tapped Nick Ke­her as CFO of the group com­pris­ing of spe­cial­ty phar­ma busi­ness and clin­i­cal tri­al ser­vices. Most re­cent­ly head of the Eu­ro­pean health­care eq­ui­ty re­search team at the Roy­al Bank of Cana­da, Ke­her suc­ceeds Mar­tin Abell, who’s re­signed af­ter three years.

Al­ler­gan has poached Mitchell Math­is, who has led FDA’s psy­chi­a­try prod­uct di­vi­sion for 12 years, to be its CMO for CNS prod­ucts. His “role is in med­ical af­fairs, not reg­u­la­to­ry,” a com­pa­ny spokesper­son told Bio­Cen­tu­ry. Tiffany Far­chione, Math­is’ deputy, will step up as act­ing di­rec­tor.

Leah Christl, di­rec­tor of the FDA’s Ther­a­peu­tic Bi­o­log­ics and Biosim­i­lars Staff in the Of­fice of New Drugs, has de­cid­ed to leave the agency and will de­part 22 Feb­ru­ary. Christl is mov­ing to Am­gen in the role of ex­ec­u­tive di­rec­tor, glob­al reg­u­la­to­ry and R&D pol­i­cy.

Big Phar­ma vet An­drew Daw­son has joined Cedil­la Ther­a­peu­tics as chief hu­man re­sources of­fi­cer. He jumps from a brief stint at En­zy­vant, which fol­lows roles at No­var­tis, Roche and Shire.

Sue Siegel, CEO of GE Ven­tures, has joined the board of DNA se­quenc­ing gi­ant Il­lu­mi­na $ILMN.

 

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).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.