Peer Re­view: For­mer FDA Com­mish Califf will split his time be­tween Ver­i­ly and Duke

→ Af­ter a lit­tle over a year and a half at Al­pha­bet’s Ver­i­ly, neu­ro­sci­en­tist Dr. Thomas In­sel is join­ing the mys­te­ri­ous com­pa­ny’s ex­o­dus of tal­ent and call­ing it quits. In­sel ran the Na­tion­al In­sti­tute of Men­tal Health pri­or to his gig at Ver­i­ly. These days you can find him as the pres­i­dent and co-founder at a start­up called Mind­strong Health, which “has de­vel­oped and patent­ed a bio­mark­er pan­el that mea­sures brain func­tion from in­ter­ac­tion pat­terns cap­tured pas­sive­ly and con­tin­u­ous­ly from hu­man-com­put­er in­ter­faces found in ubiq­ui­tous mo­bile tech­nol­o­gy.”

Robert Califf

En­ter­ing the Ver­i­ly realm is Robert Califf. The ex-FDA com­mis­sion­er pre­vi­ous­ly worked with Ver­i­ly head An­dew Con­rad be­fore to head­ing up the agency. He’s al­so back at Duke Uni­ver­si­ty. “Af­ter con­clud­ing what has been an amaz­ing ex­pe­ri­ence as FDA Com­mis­sion­er, I’m ex­cit­ed to turn to a new ca­reer with Ver­i­ly and Duke Uni­ver­si­ty,” says Califf in his Ver­i­ly blog post.

→  Al­most ex­act­ly four years af­ter be­ing named per­ma­nent chief sci­en­tif­ic of­fi­cer at Bio­gen, Spy­ros Ar­ta­va­nis-Tsakonas has qui­et­ly left the com­pa­ny. The cell bi­ol­o­gy spe­cial­ist has been a pro­fes­sor at Har­vard Med­ical School since 1999. And now he’s head­ed back with fund­ing from Bio­gen on new re­search in­to neu­rode­gen­er­a­tive dis­eases. The big biotech gets an op­tion on li­cens­ing new tech from his lab in ex­change for the fund­ing.

→  For­mer Sarep­ta CEO Chris Garabe­di­an has won $15 mil­lion from some loy­al back­ers at Per­cep­tive Ad­vi­sors to es­tab­lish Xon­toge­ny, which promis­es to guide biotech star­tups through the first crit­i­cal stage of de­vel­op­ment lead­ing to proof-of-con­cept da­ta. Garabe­di­an is run­ning the show and he’s now re­cruit­ing a team.

Patrick Am­stutz has made the jump from in­ter­im CEO to the re­al deal. Am­stutz helmed Mol­e­c­u­lar Part­ners af­ter Chris­t­ian Zahn left the job late last year.

Ox­itec CEO Ha­dyn Par­ry is join­ing the moth­er ship. Par­ry has been bumped up to VP of cor­po­rate de­vel­op­ment, Eu­rope, the Mid­dle East, and Africa for In­trex­on. Look for Mark Carnegie-Brown to be in charge of Ox­itec as the new CEO.

→  Is­rael’s Al­co­bra said that CEO Yaron Daniely is step­ping down to head up the tech trans­fer arm at He­brew Uni­ver­si­ty.

Cy­tomX is shuf­fling the deck, with Bob Goetz ex­it­ing the CFO po­si­tion of the South San Fran­cis­co, CA-based biotech to “pur­sue new op­por­tu­ni­ties.” De­ban­jan Ray is now the new CFO and head of cor­po­rate de­vel­op­ment. “De­ban­jan has been in­stru­men­tal to Cy­tomX’s busi­ness suc­cess, in­clud­ing struc­tur­ing and ex­e­cut­ing col­lab­o­ra­tions that have re­sult­ed in more than $300 mil­lion in up­front and mile­stone pay­ments to date and to­tal po­ten­tial deal val­ue in ex­cess of $5 bil­lion,” said CEO Sean Mc­Carthy.

→ Ac­tini­um CEO Kaushik J. Dave and Chief Tech­nol­o­gy Of­fi­cer Dra­gan Ci­cic have both re­signed from the com­pa­ny

 

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.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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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.

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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.