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

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

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“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

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They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

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After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

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FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

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A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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