Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Blue­bell Cap­i­tal Part­ners, a proxy brawler fresh off a cam­paign to oust glob­al food gi­ant Danone’s CEO and most of its board of di­rec­tors, has bought a stake in UK drug­mak­er Glax­o­SmithK­line with its eyes trained di­rect­ly on Em­ma Walm­s­ley, the Fi­nan­cial Times re­port­ed Wednes­day.

The Lon­don-based hedge fund joins an­oth­er no­to­ri­ous ac­tivist firm in Paul Singer’s El­liott Man­age­ment, which ear­li­er this year called for a shake­up in lead­er­ship at GSK to han­dle what the com­pa­ny de­scribed as a wealth of rich­es across the drug gi­ant’s port­fo­lio hin­dered by lim­it­ed vi­sion from top staff.

Now, Blue­bell is pil­ing on with sim­i­lar claims about the drug­mak­er’s lead­er­ship, pen­ning a let­ter to GSK chair Jonathan Symonds that de­mand­ed Walm­s­ley reap­ply for her job as the firm scouts for po­ten­tial re­place­ments, FT re­port­ed. Blue­bell re­port­ed­ly al­so called for more “sci­en­tif­ic ex­pe­ri­ence” on GSK’s board.

While rel­a­tive­ly tiny in terms of as­sets man­aged, Blue­bell has held an out­sized role in dri­ving change at mas­sive com­pa­nies by gath­er­ing ac­tivists in­to what the firm calls a “crit­i­cal mass” for change, ac­cord­ing to a Hedge­week pro­file in Jan­u­aryThat in­flu­ence came to bear at Danone, where Blue­bell drove out most of the com­pa­ny’s lead­er­ship af­ter a short-lived cam­paign.

Blue­bell’s par­tic­i­pa­tion could al­so form a par­tic­u­lar­ly for­mi­da­ble one-two punch with El­liott, which has built a rep­u­ta­tion of its own in over­haul­ing lead­er­ship at a few name-brand biotechs. The in­vestor took on a multi­bil­lion-pound stake in GSK back in April af­ter the drug­mak­er missed its beat in Q1 on the heels of a par­tic­u­lar­ly ug­ly stretch of set­backs for its on­col­o­gy busi­ness.

Most re­cent­ly, El­liott was at the tip of the spear in call­ing for change at the top at rare dis­ease spe­cial­ist Alex­ion, call­ing on the drug­mak­er to launch a “proac­tive sale” af­ter a se­ries of what El­liott called dis­as­trous M&A de­ci­sions. Alex­ion would go on to sell to As­traZeneca in a deal val­ued at $39 bil­lion.

Pri­or to that, El­liott was in­stru­men­tal in push­ing Bay­er to di­vest its crop sci­ences di­vi­sion — for­mer­ly Mon­san­to — af­ter the $66 bil­lion buy­out and lead prod­uct Roundup proved a law­suit night­mare for the Ger­man gi­ant. El­liott has al­so had its run-ins with Ab­b­Vie, su­ing the com­pa­ny for walk­ing away from a po­ten­tial $55 bil­lion buy­out of Shire, which would even­tu­al­ly find a new home at Japan­ese drug­mak­er Take­da.

For Walm­s­ley, the re­newed op­po­si­tion comes as her com­pa­ny looks to of­fload a flail­ing con­sumer health busi­ness and stream­line around growth ar­eas in on­col­o­gy and rare dis­ease. GSK im­port­ed Genen­tech vet­er­an and on­col­o­gy gu­ru Hal Bar­ron back in 2017 to hit the re­set but­ton on the com­pa­ny’s pipeline, which in re­cent months has seen set­back af­ter set­back, mak­ing in­vestors im­pa­tient for an un­mit­i­gat­ed win.

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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