As­traZeneca chief Pas­cal So­ri­ot her­alds the start of a 'pe­ri­od of sus­tained growth for years to come'

As­traZeneca CEO Pas­cal So­ri­ot de­clared vic­to­ry to­day in the long-run­ning fight to turn around the strug­gling phar­ma gi­ant, gain­ing a sig­nif­i­cant spurt in Q3 sales for the com­pa­ny and point­ing to a pe­ri­od of “sus­tained growth” dri­ven by new prod­uct de­vel­op­ment, a strong com­mer­cial or­ga­ni­za­tion and suc­cess in the grow­ing Chi­na drug mar­ket.

Yes, rev­enue slid 14%, large­ly as a re­sult of a lull in the kind of ag­gres­sive “ex­ter­nal­iza­tion” from its drug port­fo­lio that has buoyed the com­pa­ny for years. But with its big 3 can­cer drugs — Lyn­parza, Tagris­so and now Imfinzi — lead­ing the way, the com­pa­ny has a work­able strat­e­gy to keep ex­pand­ing sales. That starts with a 9% in­crease in Q3 while year-to-date there’s been a 2% growth in this col­umn.

By any stan­dard, that is a ma­jor achieve­ment for the com­pa­ny and the ex­ec­u­tive crew in charge. And they $AZN would agree with that.

“To­day marks an im­por­tant day for the fu­ture of As­traZeneca,” So­ri­ot not­ed at the top of to­day’s re­lease, “with the per­for­mance in the quar­ter and year to date show­ing what we ex­pect will be the start of a pe­ri­od of sus­tained growth for years to come. Com­mer­cial ex­e­cu­tion has been ex­cep­tion­al and our new med­i­cines are now firm­ly es­tab­lished as the dri­vers of growth, sup­port­ing our con­tin­ued suc­cess in emerg­ing mar­kets.”

Of all the Big Phar­ma com­pa­nies, As­traZeneca has suf­fered some of the worst loss­es due to gener­ic com­pe­ti­tion for their old fran­chise drugs. That left So­ri­ot bat­ting away a takeover at­tempt by Pfiz­er as he worked to build a new foun­da­tion of drugs that can de­liv­er steadi­ly ris­ing, block­buster re­turns. 

Key to the process was gain­ing an ear­ly, break­through ap­proval for their PARP Lyn­parza, while go­ing on to build new rev­enue by adding sup­ple­men­tal ap­provals. Three more PARPs have now crowd­ed in be­hind As­traZeneca, but the UK com­pa­ny clear­ly has a com­mand­ing lead there. Through its multi­bil­lion-dol­lar part­ner­ship at Mer­ck, As­traZeneca is now in po­si­tion to book hun­dreds of mil­lions in added pay­ments in Q4’s ex­ter­nal­iza­tion col­umn — an­oth­er near term coup.

Tagris­so and Imfinzi, its PD-L1 drug, are both be­ing po­si­tioned for new growth based on clin­i­cal tri­al suc­cess­es. We still haven’t heard about the sec­ond big hur­dle for Imfinzi’s MYS­TIC study, which failed the first goal. But As­traZeneca’s out­line on its growth plans in­cludes a Q4 reg­u­la­to­ry fil­ing — though that out­come has been dis­count­ed now that the PA­CIF­IC study has come through to open up a sig­nif­i­cant new can­cer mar­ket for the com­pa­ny.

Sev­er­al of So­ri­ot’s strate­gies around new prod­uct de­vel­op­ment and sell­ing off as­sets — in­clud­ing but not lim­it­ed to mar­gin­al or dis­ap­point­ing prod­ucts — is fo­cused around the prin­ci­ple that the com­pa­ny need­ed to sim­pli­fy its ap­proach, con­cen­trat­ing on block­buster, stan­dard-of-care as­sets that could make a ma­jor dif­fer­ence. As­traZeneca un­der­scored that with a 6% drop in R&D ex­pens­es in Q3, even as the com­pa­ny con­tin­ues to pur­sue some big out­comes. And its ros­ter of drugs to watch in­cludes their asth­ma drug teze­pelum­ab, which has shown some re­al promise in treat­ing se­vere asth­ma.

At the same time, the phar­ma gi­ant con­tin­ues to win­now out the weak­est drugs from the pipeline.

Two months ago re­searchers bull­ish­ly out­lined the ef­fec­tive­ness of an As­traZeneca drug called vis­tusert­ib com­bined with chemo in treat­ing drug-re­sis­tant cas­es of ovar­i­an and lung can­cer. But in their pipeline up­date to­day the com­pa­ny not­ed it is re­mov­ing the mTOR in­hibitor from Phase II while al­so ax­ing an ear­ly-stage com­bo study with Calquence.

As­traZeneca has had plen­ty of set­backs along the way, and will cer­tain­ly have more to come. But while skep­tics will con­tin­ue to chal­lenge the com­pa­ny on rev­enue and over­all per­for­mance, you can’t ig­nore the im­por­tant achieve­ment So­ri­ot is point­ing to to­day.


Im­age: Pas­cal So­ri­ot. AP IM­AGES

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.