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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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