GSK déjà vu: Time for a top-down switch as new CEO tries to con­quer old R&D demons

Close to a decade ago, GSK CEO An­drew Wit­ty and R&D chief Mon­cef Slaoui de­cid­ed they need­ed to do some­thing new and dif­fer­ent to fire up a lack­lus­ter R&D group, look­ing to shock a sys­tem where re­searchers were far too fo­cused on hang­ing on to un­promis­ing drugs.

Now, new CEO Em­ma Walm­s­ley says she has in­her­it­ed the ex­act same prob­lem they vowed to fix.

Walm­s­ley notes the com­pa­ny needs new block­buster drugs that can bring in more than a bil­lion dol­lars each if she ex­pects to liv­en things up on the bot­tom line. An­a­lysts (hel­lo, GSK) have been say­ing the same thing for years, shak­ing their heads over the drug ap­provals that did come through with­out much chance of chang­ing the game in the dis­eases they ad­dressed.

The CEO im­me­di­ate­ly point­ed to the same source of the prob­lem as her pre­de­ces­sors: it’s the R&D group’s fault, where in­ves­ti­ga­tors are too en­trenched around the wrong as­sets.

“If you’ve been work­ing on an as­set for decades in R&D it’s very hard to de­cide it isn’t im­por­tant enough to take for­ward . . . so it’s not sur­pris­ing that peo­ple’s hu­man mo­ti­va­tion is to keep pro­gress­ing stuff,” the CEO said in an in­ter­view with the Fi­nan­cial Times.

Walm­s­ley’s de­ci­sion to shake things up comes with new au­thor­i­ty for her phar­ma chiefs — Jack Bai­ley and Luke Miels — to start call­ing the shots on what the pri­or­i­ties should be.  Wit­ty and Slaoui came up with DPUs, or Dis­cov­ery Per­for­mance Units, say­ing that each team had to jus­ti­fy their ex­is­tence at the end of the first three years, or else.

‘Or else’ turned out to be some new as­sign­ments, for a few re­searchers, though there was al­so plen­ty of dis­rup­tion with a ma­jor swap with No­var­tis or the US lay­offs that fol­lowed the R&D group’s poor per­for­mance.

Now, rather than look­ing for a bot­tom-up ap­proach to in­no­va­tion, GSK will go with a top-down stan­dard as Walm­s­ley kicks loose 30 pro­grams and adds new can­cer and im­muno-in­flam­ma­to­ry drugs as she shifts fo­cus to the key US mar­ket.

GSK al­so re­cent­ly de­cid­ed to shut­ter a neu­ro­sciences R&D group in Shang­hai, an­oth­er lega­cy of the Wit­ty/Slaoui regime. What comes next?

The big ques­tion for Walm­se­ly will be whether she can bring new life to a tor­pid and un­pro­duc­tive re­search arm that has been ham­mered by re­peat­ed cut­backs. For the rank and file, it’s time to face an old re­al­i­ty — again.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.