Google’s Ver­i­ly and Glax­o­SmithK­line hatch a $713M plan to spark a biorev­o­lu­tion

Glob­al phar­ma gi­ant Glax­o­SmithK­line is team­ing up with Google’s life sci­ences ven­ture Ver­i­ly, chan­nel­ing its four-year ef­fort to cre­ate new nan­otech-based bio­elec­tron­ic ther­a­peu­tics in­to a start­up called Gal­vani Bio­elec­tron­ics, with joint plans to in­vest $713 mil­lion in­to the ven­ture over the next sev­en years.

GSK’s Chair­man of Vac­cines, Mon­cef Slaoui

GSK’s Mon­cef Slaoui has billed this ef­fort as a rev­o­lu­tion­ary at­tempt to break out of the tra­di­tion­al mode of ther­a­peu­tic de­vel­op­ment, re­think­ing the sci­ence and tech­nol­o­gy of drug R&D to cre­ate a com­plete­ly new de­vel­op­ment field in elec­tro­ceu­ti­cals, which will now be fo­cused on in­flam­ma­to­ry, meta­bol­ic and en­docrine dis­or­ders, in­clud­ing type 2 di­a­betes. And now Ver­i­ly Life Sci­ences, for­mer­ly Google Life Sci­ences which op­er­ates un­der the new Al­pha­bet ban­ner, is mak­ing a big biotech bet that it can live up to its mis­sion to trans­form med­i­cine by part­ner­ing with GSK.

Gal­vani will be based in the UK biotech hub in Steve­nage, with an­oth­er re­search cen­ter at Ver­i­ly’s cam­pus in South San Fran­cis­co. They’ll get start­ed with a staff of 30 and GSK’s start­up en­deav­ors to date. Glaxo will own 55% of the com­pa­ny, with Ver­i­ly tak­ing the rest. Slaoui has been tapped to chair the new com­pa­ny and shep­herd one of his fa­vorite projects.

They’re not think­ing small. And they aren’t stop­ping at 30. A spokesper­son for Ver­i­ly of­fered End­points this in­sight on the new jobs that are ex­pect­ed to be cre­at­ed.

“In ad­di­tion to the 30 ini­tial FTEs, Gal­vani will fund and in­te­grate – both through strate­gic col­lab­o­ra­tions with the two par­ent com­pa­nies and with oth­ers – a broad range of oth­er col­lab­o­ra­tions in acad­e­mia and with R&D com­pa­nies, build­ing on the suc­cess­ful mod­el we’ve de­vel­oped in GSK Bio­elec­tron­ics over three years. It will in­volve ap­prox­i­mate­ly 100 FTEs (full time equiv­a­lents) at Ver­i­ly and about 100 FTEs across the spec­trum of oth­er part­ner­ships. By ef­fec­tive­ly ty­ing such a net­work of ex­perts to­geth­er, we be­lieve we can rapid­ly ac­cel­er­ate the de­vel­op­ment of bio­elec­tron­ic med­i­cines.”

“This is an am­bi­tious col­lab­o­ra­tion al­low­ing GSK and Ver­i­ly to com­bine forces and have a huge im­pact on an emerg­ing field,” said Ver­i­ly Chief Tech­nol­o­gy Of­fi­cer Bri­an Otis. “Bio­elec­tron­ic med­i­cine is a new area of ther­a­peu­tic ex­plo­ration, and we know that suc­cess will re­quire the con­flu­ence of deep dis­ease bi­ol­o­gy ex­per­tise and new high­ly minia­turised tech­nolo­gies.

Ver­i­ly’s big agen­da is to har­ness new life sci­ence tech­nol­o­gy in search of a mul­ti­tude of new ways to im­prove hu­man health and rev up a longer life with­out the many af­flic­tions that drag peo­ple down the longer they live.

In Glax­o­SmithK­line’s case, they start­ed out with spe­cif­ic dis­eases in mind, look­ing to di­rect nerve stim­u­la­tors that could, for ex­am­ple, in­flu­ence rheuma­toid arthri­tis. The com­pa­ny set up a spe­cial $50 mil­lion fund to help jump­start a small group of biotechs spe­cial­iz­ing in elec­tro­ceu­ti­cals. A $1 mil­lion sci­ence prize was set up to help gin up some ex­cite­ment. And col­lab­o­ra­tions fol­lowed with oth­er com­pa­nies in the field. More part­ner­ing is ex­pect­ed as the new com­pa­ny gets up and run­ning.

GSK said ear­li­er this year that it plans to be in the clin­ic with its first pro­grams in 2017.

A cou­ple of years ago, GSK’s Slaoui, who now runs the vac­cines group for GSK, had this to say in an in­ter­view with The Chi­na Post:

(W)e re­al­ized that when we use chem­i­cal struc­ture or re­com­bi­nant pro­tein as a med­i­cine, what we use in fact are the struc­tures of these med­i­cines to in­ter­act with the struc­ture of a re­cep­tor or pro­tein in our body … Our body us­es struc­ture to com­mu­ni­cate with bi­ol­o­gy, but it al­so us­es elec­tri­cal im­puls­es which go through our nerves. So we asked the ques­tion: ‘Can we use elec­tri­cal im­puls­es to mod­i­fy the way or­gans func­tion?’”

“We have ev­i­dence that our body can read elec­tri­cal mes­sages we give it. This has cre­at­ed a new vi­sion to de­sign nano-tech­no­log­i­cal de­vices that will be able to read the elec­tri­cal sig­nals that are trans­mit­ting in our nerves, and hope­ful­ly (we will) be able to iden­ti­fy ab­nor­mal sig­nals … and cor­rect it by giv­ing it a dif­fer­ent sig­nal.”

To test that con­cept, in­ves­ti­ga­tors found that the right elec­tron­ic puls­es could spur the pan­creas to pro­duce in­sulin, to treat di­a­betes. And an­oth­er pre­clin­i­cal test worked on blood pres­sure.

Cre­at­ing a new modal­i­ty for ther­a­peu­tic de­vel­op­ment, though, presents huge and ex­pen­sive hur­dles, es­pe­cial­ly when you’re talk­ing about mass ail­ments like di­a­betes and heart dis­ease. Reg­u­la­tors put up high bars on safe­ty that most biotechs could nev­er hope to clear with a small, lim­it­ed re­search bud­get.

Ver­i­ly and Google, though, are a whole dif­fer­ent mat­ter.

Google has the kind of deep pock­ets that most com­pa­ny ex­ecs can on­ly dream about. That’s al­so help­ing fund Cal­i­co, which has stealth­ily moved ahead on a num­ber of pro­grams aimed at healthy longevi­ty.

STAT has been tak­ing some round­house swings at Ver­i­ly, claim­ing that its top de­vel­op­ment pro­grams are more sci­ence fic­tion than po­ten­tial near-term tools for the life sci­ences mar­ket.

GSK doesn’t ap­pear to be both­ered by that, though.

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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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.

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).

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.

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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