Can GSK’s new R&D strat­e­gy re­sus­ci­tate the worst per­former in Big Phar­ma?

Bioreg­num
The view from John Car­roll

The new phar­ma chief at GSK is lay­ing out their new pipeline game plan, which should be­gin in earnest once Hal Bar­ron ar­rives to take over R&D.

Luke Miels

In an in­ter­view with Reuters, Luke Miels out­lined plans to rev up a dor­mant busi­ness de­vel­op­ment op­er­a­tion $GSK, jump­ing off the side­lines to start li­cens­ing in ear­ly-stage drugs in can­cer and im­munol­o­gy.

The ini­tial pipeline fo­cus at GSK will cen­ter on its BC­MA-tar­get­ing mul­ti­ple myelo­ma pro­gram, NY-ESO — part­nered with Adap­ti­m­mune — and ICOS. This will play out as the com­pa­ny launch­es its new shin­gles vac­cine, an HIV drug wide­ly tapped as a block­buster and its lat­est three-in-one in­haler Trel­e­gy.

And he plans to take a page out of the As­traZeneca play­book, where he was a trust­ed lieu­tenant un­der Pas­cal So­ri­ot, stay­ing fo­cused on core ar­eas. He told Reuters: “I saw that hap­pen at As­tra and I think the con­di­tions are in place where we can do some­thing very, very in­ter­est­ing at GSK.”

Don’t look for any­thing quick, he says, with a gap on launch­es un­til 2020.

So let’s break that down.

Em­ma Walm­s­ley

GSK has had one of the weak­est phar­ma R&D or­ga­ni­za­tions in the Big Phar­ma league for years. Its de­ci­sion to swap its late-stage and com­mer­cial port­fo­lio of can­cer as­sets for vac­cines was a strate­gic blun­der, leav­ing No­var­tis as an even big­ger play­er in the biggest field in the in­dus­try just as it was ex­plod­ing.

The phar­ma R&D group at GSK is run sep­a­rate­ly from HIV, which is the precinct of Vi­iV, a ma­jor­i­ty owned sub­sidiary, and vac­cines, which de­vel­oped Shin­grix. GSK has con­sis­tent­ly over­es­ti­mat­ed the com­mer­cial im­pact of its res­pi­ra­to­ry fran­chise, which was sup­posed to be its block­buster sav­ior years ago.

The de­ci­sion to fo­cus BD on ear­ly-stage work sim­ply repli­cates all of its old weak­ness­es. The phar­ma R&D group has a well es­tab­lished rep for en­thu­si­as­ti­cal­ly seiz­ing on ear­ly-stage work and then ei­ther kick­ing it in­to obliv­ion or fail­ing. Its am­bi­tious late-stage ef­forts in phar­ma all failed, leav­ing it in the weak state it’s in now.

It’s been clear that GSK was go­ing back in­to can­cer, where it re­tained ear­ly-stage ef­forts, once new CEO Em­ma Walm­slsey re­cruit­ed Dana-Far­ber chief Lau­rie Glim­ch­er from the board at Bris­tol-My­ers Squibb. The CEO then made it of­fi­cial in an an­nounced R&D re­or­ga­ni­za­tion and fol­lowed up by in-li­cens­ing the Adap­ti­m­mune drug and hir­ing an on­col­o­gy ex­pert with one of the high­est pro­files in the world to take over where GSK has had a decade-long swoon.

Now, in­stead of pay­ing a pre­mi­um to con­cen­trate on late-stage work, the on­ly place where a Big Phar­ma can dis­tin­guish it­self quick­ly, Miels is sig­nal­ing that the com­pa­ny will take years more in revving up the pipeline. With such a poor his­to­ry on in­no­va­tion, they’ll need to get lucky.

We’ll see if Bar­ron has any­thing else in mind.

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.