Lag­gard Lil­ly says its CDK 4/6 drug abe­maci­clib scored in PhI­II, while ri­vals at No­var­tis, Pfiz­er sharp­en their knives

Levi Gar­raway, Lil­ly

Just a week af­ter No­var­tis scored a key ap­proval for its CDK 4/6 can­cer drug, Eli Lil­ly is an­nounc­ing that its long-await­ed Phase III read­out for its ri­val drug abe­maci­clib looks good. We won’t get the da­ta un­til lat­er, but the phar­ma gi­ant says its MONARCH-2 tri­al comes with pos­i­tive pro­gres­sion-free da­ta on ad­vanced hor­mone-re­cep­tor-pos­i­tive, HER2 neg­a­tive breast can­cer.

In­ves­ti­ga­tors com­pared abe­maci­clib com­bined with ful­ves­trant to ful­ves­trant alone. And the da­ta set up an FDA fil­ing some­time in the next three months.

If it’s suc­cess­ful, Lil­ly will still be jump­ing in­to the CDK 4/6 game far be­hind Pfiz­er, which was first to the mar­ket with Ibrance, and No­var­tis’ ri­bo­ci­clib, now be­ing mar­ket­ed as Kisqali.

Lil­ly had been keep­ing its fin­gers crossed that it could get the pos­i­tive da­ta it need­ed in an in­ter­im analy­sis, but dis­ap­point­ed in­vestors last sum­mer with the news that it would need to go all the way to the end. Now, with a break­through drug des­ig­na­tion, Lil­ly will do every­thing it can to cut the re­view cy­cle short so it can hit the mar­ket AS­AP.

But its late ar­rival could car­ry a heavy penal­ty.

Ac­cord­ing to the key tri­al de­sign, Lil­ly’s drug was re­strict­ed to pa­tients who have not pre­vi­ous­ly been treat­ed with a CDK 4/6 drug. If that makes its way to the la­bel, Lil­ly’s treat­ment would not be al­lowed for any pa­tient who had been treat­ed with ei­ther Pfiz­er’s Ibrance or No­var­tis’s ri­bo­ci­clib (LEE011). And with both of those drugs on the mar­ket ahead of Lil­ly, that could sig­nif­i­cant­ly shrink its mar­ket reach.

Leerink’s Sea­mus Fer­nan­dez fleshed out Lil­ly’s time­line this morn­ing, in­clud­ing a like­ly AS­CO pre­sen­ta­tion, af­ter talk­ing to ex­ecs. He not­ed:

The com­pa­ny has the “da­ta pack­age ready to go” and will sub­mit an NDA for sin­gle-agent abe­maci­clib in 2Q17 based on the MONARCH-1 study; the pack­age will in­clude da­ta on re­sponse rate (RR), PFS and OS (over­all sur­vival). An ad­di­tion­al ap­pli­ca­tion sub­mis­sion for MONARCH-2 is ex­pect­ed in 3Q17. Mgmt al­so con­firmed that the MONARCH-3 study, which is in com­bi­na­tion with letro­zole, is ex­pect­ed to have an in­ter­im analy­sis in 2Q and the fi­nal read­out is ex­pect­ed be­fore the end of 2017.

“We are ex­cit­ed about the out­come of our first Phase III study for abe­maci­clib. These da­ta are an im­por­tant mile­stone in our goal of bring­ing abe­maci­clib to pa­tients with ad­vanced breast can­cer, and we look for­ward to our up­com­ing con­ver­sa­tions with reg­u­la­tors,” said Levi Gar­raway, SVP, glob­al de­vel­op­ment and med­ical af­fairs, Lil­ly On­col­o­gy. “This is an­oth­er ex­am­ple of Lil­ly’s com­mit­ment to de­liv­er­ing break­through treat­ments and im­prov­ing out­comes for pa­tients with can­cer.”

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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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.

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.