As­traZeneca and Am­gen qui­et­ly ad­mit teze­pelum­ab set­back as the Dupix­ent chal­lenger heads to FDA

As­traZeneca and Am­gen have block­buster am­bi­tions for their teze­pelum­ab an­ti­body, aim­ing to chal­lenge the Re­gen­eron and Sanofi gi­ant Dupix­ent in asth­ma and re­lat­ed res­pi­ra­to­ry mal­adies. But as part of its sec­ond quar­ter up­date Thurs­day morn­ing, the big British drug­mak­er qui­et­ly scut­tled plans in an­oth­er in­di­ca­tion, rais­ing doubt over how big a bite it will take out of the Dupix­ent pie.

Af­ter flunk­ing two Phase II stud­ies in atopic der­mati­tis, As­traZeneca dropped plans for teze­pelum­ab to treat the con­di­tion al­to­geth­er, the com­pa­ny re­vealed Thurs­day morn­ing. The move comes just a few weeks af­ter the an­ti­body won pri­or­i­ty re­view from the FDA in asth­ma, where a de­ci­sion is ex­pect­ed in the first quar­ter next year.

End­points News has reached out to As­traZeneca for com­ment and will up­date ac­cord­ing­ly.

Though teze­pelum­ab has — most­ly — passed all the nec­es­sary check­points in asth­ma, atopic der­mati­tis has been an­oth­er sto­ry al­to­geth­er. The first mis­step came back in 2017, when the an­ti­body whiffed on a Phase IIa pri­ma­ry end­point in AD, com­ing up short on an eczema mea­sure­ment scale com­pared to place­bo.

In this study, teze­pelum­ab was eval­u­at­ed over a 12-week pe­ri­od in 113 pa­tients with mod­er­ate to se­vere atopic der­mati­tis. Though a nu­mer­i­cal­ly greater por­tion of the drug arm saw im­prove­ment against place­bo plus top­i­cal cor­ti­cos­teroids, the can­di­date missed sta­tis­ti­cal sig­nif­i­cance with a p-val­ue of 0.091.

Then came a Phase IIb tri­al in 251 pa­tients look­ing at both a monother­a­py treat­ment course and an ad­junct reg­i­men, al­so in mod­er­ate to se­vere AD. This study was halt­ed some­time in the sec­ond quar­ter of 2020 due to fu­til­i­ty, ac­cord­ing to Am­gen’s earn­ings re­port at the time, with the phar­ma not­ing the study didn’t have any im­pact on asth­ma and COPD re­search.

By and large, that hy­poth­e­sis has held true. As­traZeneca and Am­gen won their pri­or­i­ty re­view based on a Phase III study that cut the rate of se­vere asth­ma at­tacks on top of stan­dard of care. Teze­pelum­ab al­so man­aged con­sis­tent re­sults re­gard­less of pa­tients’ base­line eosinophil counts and al­ler­gy sta­tus, an area where some an­a­lysts have sug­gest­ed the an­ti­body might have an ad­van­tage over the Re­gen­eron/Sanofi gi­ant.

David Reese

But the pro­gram al­so flopped a sep­a­rate Phase III study in the same pop­u­la­tion, a re­sult Am­gen R&D chief David Reese called “sur­pris­ing” last De­cem­ber. Though Reese at­trib­uted the miss to pos­si­ble tri­al de­sign flaws, an­a­lysts took a more pes­simistic look, not­ing that Dupix­ent had suc­cess­ful­ly re­duced cor­ti­cos­teroid use in a sim­i­lar tri­al.

As As­traZeneca and Am­gen con­tin­ue to chart a block­buster path — some peak sales fore­casts have pegged $2.5 bil­lion an­nu­al sales for the an­ti­body — they may strug­gle to reach the heights of com­peti­tors. Dupix­ent is ap­proved to treat eczema and atopic der­mati­tis and over­all sales in­creased a whop­ping 45% in the sec­ond quar­ter of 2021, Sanofi re­vealed Thurs­day.

That growth amount­ed to near­ly $1.5 bil­lion in the three-month pe­ri­od alone. It re­mains to be seen how quick the teze­pelum­ab up­take will be, but As­traZeneca and Am­gen are hop­ing for a quick and easy time at the FDA to get things go­ing.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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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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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”