Emma Walmsley (GSK via investor day livestream)

Mul­ti­va­lent mR­NA vac­cines, I/O 3.0, long-act­ing HIV drugs: The $46B game is on for the new Glax­o­SmithK­line

To un­der­stand the new Glax­o­SmithK­line that Em­ma Walm­s­ley is promis­ing to ush­er in, one must see through the old GSK.

“We know this has been a com­pa­ny that has peren­ni­al­ly dis­ap­point­ed when you look at the first half of the last decade,” the CEO said in one of her fi­nal re­marks at the long-an­tic­i­pat­ed in­vestor day.

But af­ter four years of strate­gic trans­for­ma­tion and in­vest­ment, her top team is ready to take the wraps off a shiny new ver­sion of the Big Phar­ma that, among oth­er things, will strive to de­liv­er £33 bil­lion ($46 bil­lion) in an­nu­al sales by 2031. It will start with a planned de­merg­er of the con­sumer health busi­ness in­to a sep­a­rate com­pa­ny in the mid­dle of next year, while the new GSK re­tains a 20% stake as a “short-term fi­nan­cial in­vest­ment.”

Hal Bar­ron

The ma­jor­i­ty of the rev­enue should come from cur­rent late-stage projects, hand­picked by R&D chief Hal Bar­ron in con­sul­ta­tion with chief com­mer­cial of­fi­cer Luke Miels.

The end goal? A “step change” in per­for­mance to re­vi­tal­ize the busi­ness around new vac­cines and spe­cial­ty med­i­cines — two ar­eas that are now in­ter­twined as pre­ven­tion and treat­ment con­verge.

For any­one who’s been fol­low­ing the R&D roadmap that Bar­ron laid out in 2018 af­ter tak­ing over, it can sound like more of the same. Sure, the sep­a­ra­tion of the con­sumer health busi­ness might be the most sig­nif­i­cant change for GSK in two decades; yet the com­pa­ny is stub­born­ly con­sis­tent about what it will take to thrive in the fu­ture. It’s still about the sci­ence of the im­mune sys­tem, the un­der­stand­ing of func­tion­al ge­nomics, some ma­chine learn­ing or ar­ti­fi­cial in­tel­li­gence, as well as a healthy di­et of bolt-on and li­cens­ing deals to en­hance all those ar­eas.

The dif­fer­ence could be that the clock is tick­ing. Amid threats of an ac­tivist at­tack and calls for greater re­form, Walm­s­ley, Bar­ron and oth­ers are un­der se­ri­ous pres­sure to de­liv­er, and every blun­der or set­back could be mag­ni­fied.

But if they suc­ceed, the new GSK will make a mark and cre­ate last­ing fran­chis­es across in­fec­tious dis­ease, HIV, on­col­o­gy and im­munol­o­gy. And they’ve brought in fresh blood to ex­e­cute: Ac­cord­ing to Walm­s­ley, “85% of our top 125 lead­ers are new in roles since 2017, in­clud­ing 30% re­cruit­ed ex­ter­nal­ly.”

Now that they are wrap­ping up a dras­tic re­struc­tur­ing that led to mas­sive lay­offs, she added, there are no near-term plans for an­oth­er round. It’s show­time.

Be­yond Covid-19 vac­cines

GSK may have fall­en be­hind on the glob­al hunt for a Covid-19 vac­cine, but it’s very much look­ing to get in the next-gen game.

Roger Con­nor

Like ri­vals at Pfiz­er (and cur­rent part­ners at Sanofi), GSK wants to be at the fore­front of mR­NA, ac­cord­ing to Roger Con­nor, pres­i­dent of glob­al vac­cines — which is why they’ve re­cruit­ed more than 200 sci­en­tists to fo­cus on this area and teamed up with Ger­many’s Cure­Vac to cre­ate mul­ti­va­lent vac­cines not just for Covid-19 but al­so for in­fluen­za.

De­spite the dis­ap­point­ing re­sults around a Covid-19 vac­cine made from the first gen­er­a­tion of tech­nol­o­gy, the phar­ma clear­ly sees a fu­ture in the sec­ond-gen­er­a­tion ver­sion of the tech.

Said Bar­ron:

I think the key thing to re­mem­ber at least our view is that the fu­ture for mR­NA vac­cines are go­ing to be mul­ti­va­lent. Mul­ti­va­len­cy re­quires a low­er dose be­cause you can’t give a cer­tain amount of mR­NA with­out cre­at­ing re­ac­to­genic­i­ty. So if you’re go­ing to use mul­ti­va­lent vac­cines, you got­ta get the num­ber of mi­cro­grams per va­lence down. What Cure­Vac’s sec­ond-gen­er­a­tion, I think, is telling us is that when you op­ti­mize the un­trans­lat­ed re­gions on each side, the 5’, 3’, you get more ef­fi­cient trans­la­tion, more pro­tein pro­duced.

While Shin­grix cur­rent­ly head­lines the port­fo­lio, GSK is al­so hop­ing its vac­cine for RSV — cre­at­ed from the same plat­form — would do just as well, with broad reach to both old­er adults and preg­nant women (to pre­vent in­fec­tions for their new­borns). As with menin­gi­tis, Con­nor sug­gest­ed that these are ex­am­ples of pathogens where old­er tech­nolo­gies may still have a role to play over mR­NA.

HIV, can­cer, and some wild cards

One thing that the new GSK will like­ly do is to keep drop­ping hints about its in­ter­ests through deals.

Vi­iV Health­care, the HIV-fo­cused sub­sidiary, made its goal clear as it inked a deal with Halozyme ear­li­er this week: to cre­ate ul­tra long-act­ing reg­i­mens that will com­plete­ly change how peo­ple live with the virus.

The first drug to do that is cabote­gravir, the in­te­grase in­hibitor that Vi­iV hopes will be a back­bone for an­ti­retro­vi­ral ther­a­py for the next 10 years the same way that do­lute­gravir — which is los­ing patent pro­tec­tion around 2028 — has.

In can­cer, the most re­cent ex­am­ple came in a pact with iTeos, where GSK paid $625 mil­lion up­front to grab a TIG­IT drug. Even though they’ve en­tered the race lat­er than oth­ers, Bar­ron reck­ons their own ge­nomics da­ta and an­a­lyt­ics point them to things oth­ers can’t see. If TIG­IT plus PD-1 is I/O 2.0, they might be able to add a third ther­a­py tar­get­ing the CD226 ax­is to reach I/O 3.0.

“There’s first to ap­proval, but there’s al­so first in dis­ease,” he said. “We have a re­al­ly ro­bust set of stud­ies that we’re an­tic­i­pat­ing do­ing where we think while we may not be first to mar­ket in lung, where Roche and Mer­ck are prob­a­bly both ahead, we have some par­tic­u­lar­ly in­ter­est­ing in­sights about oth­er dis­eases that we might want to pur­sue, and we can use some da­ta from ex­ter­nal sources to un­gate those tri­als.”

Then there are the in­ter­nal projects you may have to squint hard­er to find, such as Ze­ju­la — which Bar­ron touts as a best-in-class PARP in­hibitor — or the mul­ti­ple myelo­ma drug Blenrep or otil­imab for rheuma­toid arthri­tis or a new an­tibi­ot­ic dubbed gepoti­dacin or dapro­du­s­tat for ane­mia as­so­ci­at­ed with chron­ic kid­ney dis­ease.

As for the lega­cy meds that don’t fit in­to the four new fo­cus ar­eas, mov­ing for­ward GSK will lump them in­to a gen­er­al med­i­cines group that will hap­pi­ly di­vest or part­ner out non-pri­or­i­ty drugs to in­vest in the vac­cines and spe­cial­ty can­di­dates.

“(H)aving the op­por­tu­ni­ty to al­lo­cate cap­i­tal across both phar­ma and vac­cines al­lows us to put mon­ey to where the great projects are,” Bar­ron not­ed.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.