As­traZeneca gets an ear­ly green light on BTK block­buster hope­ful Calquence

Im­age: Pas­cal So­ri­ot AP Im­ages

As­traZeneca $AZN has re­ceived an ear­ly OK from reg­u­la­tors to sell its can­cer drug acal­abru­ti­nib, now un­der the brand name Calquence.

The BTK in­hibitor — be­ing set up as a ri­val to Im­bru­vi­ca from Ab­b­Vie and J&J — is a treat­ment for can­cer pa­tients with man­tle cell lym­phoma, a rare B-cell non-Hodgkin lym­phoma. The drug will be used as a sec­ond-line ther­a­py for re­lapsed/re­frac­to­ry man­tle cell lym­phoma.

As­traZeneca had ex­pect­ed the FDA to make its de­ci­sion some­time in Q1 of next year, but reg­u­la­tors were clear­ly ready to run on this one, two months af­ter they hand­ed the phar­ma gi­ant a break­through drug des­ig­na­tion to hur­ry it along.

A spokesper­son for As­traZeneca tells End­points News the av­er­age month­ly price for the drug in the US is set at $14,259, or $171,108 per year, which she adds “is on par with oth­er cur­rent­ly mar­ket­ed treat­ments in its class.”

“Man­tle cell lym­phoma is a par­tic­u­lar­ly ag­gres­sive can­cer,” said Richard Paz­dur, di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence and act­ing di­rec­tor of the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search. “For pa­tients who have not re­spond­ed to treat­ment or have re­lapsed, Calquence pro­vides a new treat­ment op­tion that has shown high rates of re­sponse for some pa­tients in ini­tial stud­ies.”

As­traZeneca paid $7 bil­lion to buy a ma­jor­i­ty stake in Ac­er­ta Phar­ma back in 2015 pri­mar­i­ly so it could snag this drug for its port­fo­lio. Peak sales for acal­abru­ti­nib have been es­ti­mat­ed at the $1 bil­lion mark, which would be a siz­able con­tri­bu­tion to the com­pa­ny’s in­come. Last year, the com­pa­ny brought in $23 bil­lion in rev­enue.

The ap­proval marks the lat­est on­col­o­gy suc­cess for CEO Pas­cal So­ri­ot, who has been push­ing for a turn­around at the phar­ma gi­ant. Key to that has been the ap­proval of Lyn­parza and Tagris­so, as well as the more re­cent suc­cess it’s had with the check­point in­hibitor Imfinzi. Adding a fourth drug to the can­cer port­fo­lio will buy So­ri­ot some more time to make the case that the com­pa­ny can start adding rev­enue af­ter years of falling num­bers.

Leerink’s Sea­mus Fer­nan­dez gives As­traZeneca high marks for the ear­ly ap­proval, with a la­bel that com­pares well with the ri­val BTK drug Im­bru­vi­ca al­ready in the mar­ket. But he al­so wants to see more da­ta be­fore de­cid­ing how the drug will fare.

Over­all, the ef­fi­ca­cy and safe­ty ap­pears to com­pare fa­vor­ably to JNJ/AB­BV’s BTK in­hibitor Im­bru­vi­ca (ibru­ti­nib), but we note this is based on a rel­a­tive­ly small num­ber of pa­tients. Calquence is cur­rent­ly in sev­er­al tri­als for a num­ber of hema­to­log­i­cal ma­lig­nan­cies, and we await da­ta from on­go­ing Phase 3 tri­als (pri­ma­ry com­ple­tion dates start­ing in 2019) in the much larg­er chron­ic lym­pho­cyt­ic leukemia (CLL) pop­u­la­tion to de­ter­mine if the drug has low­er rates of atri­al fib­ril­la­tion (AF), bleed­ing, and po­ten­tial­ly Richter’s trans­for­ma­tion than Im­bru­vi­ca.

Calquence was ap­proved us­ing the FDA’s ac­cel­er­at­ed ap­proval path­way — a short­cut for drugs meet­ing se­ri­ous con­di­tions with un­met med­ical needs. The FDA said fur­ther study is re­quired to ver­i­fy and de­scribe the clin­i­cal ben­e­fits of Calquence. As­traZeneca is con­duct­ing that tri­al now, the FDA said.

Ear­li­er this month, Re­trac­tion Watch re­port­ed that one piece of the pre­clin­i­cal puz­zle for Calquence was fab­ri­cat­ed by a re­searcher at Ac­er­ta. The case in­volved a mouse mod­el of pan­cre­at­ic can­cer and an ab­stract that was pro­duced in 2015.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

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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Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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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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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.