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

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,600+ biopharma pros reading Endpoints daily — and it's free.

Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.