GSK R&D chief Val­lance is out as its new CEO changes di­rec­tion un­der a new crew

Im­age: Patrick Val­lance.


The R&D chief at Glax­o­SmithK­line is jump­ing ship, just as new CEO Em­ma Walm­s­ley push­es through the fi­nal changes of a top-to-bot­tom shake­up aimed at spurring a more com­mer­cial­ly ef­fec­tive strat­e­gy in drug de­vel­op­ment.

Patrick Val­lance is turn­ing in his com­pa­ny cre­den­tials in ex­change for a new job in gov­ern­ment, ac­cord­ing to sev­er­al re­ports out of Lon­don, with plans to take a job as a se­nior ad­vis­er to the gov­ern­ment on sci­ence, though the Fi­nan­cial Times says that the cur­rent oc­cu­pant of that job isn’t slat­ed to leave for some months.

Both the Fi­nan­cial Times and Reuters cit­ed sources say­ing that a change is in the off­ing, with the FT not­ing that Val­lance had been feel­ing un­der pres­sure from the new regime as in­ter­nal crit­i­cism of their track record mount­ed over the course of the year. A com­pa­ny spokesper­son de­clined com­ment when I queried GSK ear­ly Fri­day.

While it’s not im­me­di­ate­ly clear whether Val­lance had some help in de­cid­ing to leave GSK, it’s un­like­ly that Walm­s­ley made an ef­fort to re­tain him. At the end of his 6-year tenure, the UK phar­ma gi­ant has found lit­tle of block­buster im­por­tance to re­port on in the late-stage phar­ma pipeline. In­no­va­tion has been large­ly lim­it­ed to vac­cines and HIV, where they are the ma­jor­i­ty own­er of Vi­iV, with some in­cre­men­tal gains on the res­pi­ra­to­ry side.

GSK, mean­while, has the 11th largest R&D bud­get in the in­dus­try at $4.5 bil­lion, mak­ing it a top 15 play­er as the ma­jors ag­gres­sive­ly pur­sued big­ger pipelines. R&D ac­count­ed for 16% of its rev­enue last year, a re­spectable amount. But with gener­ic Ad­vair pres­sures set to grow, pa­tience has been run­ning out.

Not long af­ter tak­ing the helm af­ter An­drew Wit­ty’s de­par­ture from the top job, Walm­s­ley moved to spur a change, bring­ing in As­traZeneca’s Luke Miels at phar­ma to help de­vise a bet­ter drug strat­e­gy, woo­ing Dana-Far­ber chief Lau­rie Glim­ch­er over to the board from Bris­tol-My­ers Squibb and sug­gest­ing that now might be a great time to dive deep­er in­to on­col­o­gy.

Kick­ing loose some poor R&D prospects while re­treat­ing from Chi­na, GSK’s R&D group al­so re­cent­ly com­plet­ed pick­ing up an op­tion from Adap­ti­m­mune. Just yes­ter­day the com­pa­ny tout­ed the FDA’s de­ci­sion to lend its break­through drug des­ig­na­tion to an ear­ly-stage can­cer ther­a­py guid­ed by SVP Ax­el Hoos, which helped clar­i­fy the grow­ing in­flu­ence of can­cer R&D, where fel­low British phar­ma gi­ant As­traZeneca has been mak­ing sig­nif­i­cant ad­vances.

The ques­tion now is whether GSK will reach in­to its fad­ed R&D struc­ture in search of a new R&D star, or reach out to find an ex­pert look­ing to wran­gle one of the biggest re­search groups on the plan­et. Both Val­lance and his pre­de­ces­sor in the phar­ma group, Mon­cef Slaoui, were long­time em­ploy­ees at the com­pa­ny.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.