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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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