Pfiz­er racks up its third can­cer drug OK in 2 months, but is it enough to re­place reg­u­lar price hikes?

Pfiz­er has notched an­oth­er win for the late-stage drug pipeline, scor­ing an ac­cel­er­at­ed FDA ap­proval for lor­la­tinib, now head­ed for the mar­ket as Lor­bre­na. 

The drug is an ALK/ROS1 TKI for metasta­t­ic non-small cell lung can­cer — the lat­est in a line of these drugs — now ap­proved as a sec­ond-line treat­ment for pa­tients who have failed crizo­tinib and at least one oth­er ALK in­hibitor. And you can be sure that Pfiz­er didn’t pass on the chance of boast­ing about its third can­cer drug OK in the past 2 months, fol­low­ing ap­provals for its PARP ta­la­zoparib and da­comi­tinib.

There’s a lot about this drug that il­lus­trates the cur­rent state of can­cer drug de­vel­op­ment. Pfiz­er picked up an ac­cel­er­at­ed OK on pos­i­tive Phase I/II da­ta that will need to be borne out by piv­otal re­sults. Reg­u­la­tors were hap­py to pro­vide a fast green light for a drug that fits in the treat­ment spec­trum in the wake of a fail­ure on alec­tinib, briga­tinib or cer­i­tinib. 

The key da­ta points from their Phase II post­ed a year ago:

In ALK-pos­i­tive treat­ment-naïve pa­tients, the over­all re­sponse rate was 90%. The in­tracra­nial ORR (IC-ORR) was 75%.

For ALK-pos­i­tive pa­tients pre­vi­ous­ly treat­ed with Xalko­ri (crizo­tinib) with or with­out chemother­a­py: ORR was 69%, the IC-ORR was 68%.

In ALK-pos­i­tive pa­tients pre­vi­ous­ly treat­ed with a non-crizo­tinib ALK in­hibitor with or with­out chemother­a­py: ORR was 33%.

ALK-pos­i­tive pre­vi­ous­ly treat­ed with two or three pri­or ALK in­hibitors with or with­out chemother­a­py: ORR was 39%.

ROS1-pos­i­tive re­gard­less of pri­or treat­ment: ORR was 36%.

ALK-pos­i­tive lung can­cer cov­ers about a 5% slice of the over­all mar­ket, lim­it­ing the up­side for Pfiz­er. But with the change of the guard un­der­way at Pfiz­er’s C-suite, the phar­ma gi­ant in­sists it can re­ly on its late-stage pipeline to de­liv­er the added rev­enue it needs to please Wall Street. And that fol­lowed their de­ci­sion to back off price hikes for H2.

Or is that just win­dow dress­ing for the gi­ant phar­ma op­er­a­tor known for an ag­gres­sive M&A strat­e­gy to beef up its port­fo­lio? 

“I ex­pect our ap­proach by the end of year will be, what I would char­ac­ter­ize as busi­ness as nor­mal,” CEO Ian Read told an­a­lysts about their 2019 pric­ing strat­e­gy. And that has been wide­ly in­ter­pret­ed as mean­ing more price hikes ahead.

Pfiz­er field­ed the first TKI for ALK-pos­i­tive cas­es, Xalko­ri, 7 years ago. But it’s been a big tar­get for ri­vals. No­var­tis’ Zyka­dia picked up an FDA ap­proval to chal­lenge Xalko­ri in front­line ALK-pos­i­tive lung can­cer in mid-2017. And Roche’s Ale­cen­sa came along soon af­ter.

The game plan now is to fight back for its share of the fran­chise, with the FDA’s break­through drug des­ig­na­tion to help back up their cam­paign. And Pfiz­er wants to move as quick­ly as pos­si­ble in­to front­line use for lor­la­tinib, ex­pand­ing its po­ten­tial.

“The last decade has wit­nessed dra­mat­ic im­prove­ments in the treat­ment of metasta­t­ic ALK-pos­i­tive non-small cell lung can­cer due to ear­li­er gen­er­a­tion ALK bio­mark­er-dri­ven ther­a­pies. Yet al­most all pa­tients still re­lapse due to drug re­sis­tance, with a large pro­por­tion of pa­tients de­vel­op­ing new or wors­en­ing brain metas­tases,” said Al­ice Shaw, a pro­fes­sor at Har­vard Med­ical School and di­rec­tor of the Cen­ter for Tho­racic Can­cers at Mass­a­chu­setts Gen­er­al Hos­pi­tal.

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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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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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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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.