Cel­e­brat­ing sus­tained sales growth, As­traZeneca qui­et­ly ex­e­cutes some ag­ing mid-stage drug projects

While As­traZeneca ex­ecs clus­tered by the front door to dis­cuss their third straight quar­ter with ris­ing sales dri­ven by new can­cer drugs and an ex­pand­ing grasp of the Chi­nese mar­ket, the com­pa­ny’s R&D jan­i­tors were sweep­ing its fail­ures out the back door. And the set­backs in­clude some long­time can­cer drugs in the pipeline ob­tained through a slate of mul­ti­mil­lion-dol­lar al­liances.

This quar­ter’s re­jects are topped by a group of Phase II projects, in­clud­ing preza­lum­ab, a B7RP1 mAb for Sjo­gren’s syn­drome, as an­oth­er one of As­traZeneca’s au­toim­mune projects goes south on them. The IgG2k mon­o­clon­al an­ti­body was one of the few re­main­ing au­toim­mune projects at As­traZeneca, which has con­cen­trat­ed the pipeline heav­i­ly on on­col­o­gy. The R&D team there ex­pe­ri­enced a crush­ing set­back last sum­mer with the Phase III fail­ure of an­i­frol­um­ab for lu­pus.

Its on­col­o­gy ex­its in­clude 3 mid-stage ef­forts: AZD8186, a PI3k-be­ta in­hibitor that fol­lows the ex­e­cu­tion of sev­er­al sim­i­lar drugs amid sig­nif­i­cant com­pe­ti­tion;  AZD4547, an FGFR in­hibitor for sol­id tu­mors; and Imfinzi plus ME­DI0680, adding a PD-1 to their PD-L1 that’s al­ready on the mar­ket.

Back in ear­ly 2018 As­traZeneca punt­ed its ef­forts to de­vel­op the PD-1 ME­DI0680 as a monother­a­py, leav­ing the com­bo in place. But there’s ev­i­dent­ly no room and not much hope for their idea of match­ing drugs that cov­er both ends of a sin­gle check­point strat­e­gy. The phar­ma gi­ant ac­quired the then pre­clin­i­cal ther­a­py in its $500 mil­lion Am­plim­mune buy­out — $225 mil­lion in cash and $275 mil­lion in mile­stones — back in 2013, as new CEO Pas­cal So­ri­ot be­gan a se­ries of deals to re­make the pipeline.

Pas­cal So­ri­ot

As­traZeneca al­so said it is punt­ing sev­er­al Phase I projects, in­clud­ing one that it lists as AZD4758, a KRAS in­hibitor. That is a ty­po, as the com­pa­ny ac­knowl­edged to­day. Their AZD4785 KRAS drug, ob­tained from Io­n­is in a $28 mil­lion li­cens­ing pact, was de­scribed as IO­N­IS-KRAS-2.5Rx, “a Gen­er­a­tion 2.5 an­ti­sense drug dis­cov­ered by Io­n­is de­signed to di­rect­ly tar­get KRAS, one of the most fre­quent­ly mu­tat­ed genes in can­cer.”

KRAS has been a big but tough tar­get to crack in on­col­o­gy. With As­traZeneca step­ping out, ex­pect more fo­cus on ri­val ef­forts, in­clud­ing Am­gen’s AMG 510 as well as Mi­rati’s MRTX849, which both in­volve the G12C mu­ta­tion.

As­traZeneca’s quar­ter­ly cleanups are much eas­i­er for the com­pa­ny to han­dle as So­ri­ot de­liv­ers on his long­stand­ing promise to hit rock bot­tom and bounce back up on the rev­enue side. The multi­na­tion­al may be a long way from achiev­ing the rev­enue goals laid out when the CEO was fight­ing off a Pfiz­er buy­out, but the suc­cess of block­buster can­cer drugs like Lyn­parza, Tagris­so and Imfinzi pay for the in­evitable mis­takes.

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'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“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.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

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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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).

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

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

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.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

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

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

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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