Is sec­ond time the charm for ozan­i­mod? Cel­gene starts to find out with EMA fil­ing

Cel­gene has of­fi­cial­ly em­barked on ozan­i­mod’s come­back reg­u­la­to­ry jour­ney, sub­mit­ting an ap­pli­ca­tion to the EMA days be­fore it plans to knock on the FDA’s door — just in time for the dead­line it has set for it­self.

Jay Back­strom

Say­ing Cel­gene — and Bris­tol-My­ers, which is set to ac­quire the biotech as long as the grow­ing in­vestor op­po­si­tion doesn’t de­rail the deal — has a lot rid­ing on the de­ci­sion would be an un­der­state­ment. Fol­low­ing an em­bar­rass­ing refuse-to-file episode with the FDA last Feb­ru­ary, pos­i­tive progress here is cru­cial not just to ma­te­ri­al­ize ozan­i­mod’s block­buster promis­es as a cash cow as Revlim­id ap­proach­es a patent cliff, but to prove Cel­gene’s team still pos­sess­es the de­vel­op­ment shrewd­ness that marked the com­pa­ny for years.

For the Eu­ro­pean ap­pli­ca­tion, Cel­gene has pro­vid­ed da­ta from the SUN­BEAM and RA­DI­ANCE Part B Phase III, which of­fered en­cour­ag­ing com­par­isons with Avonex in treat­ing pa­tients with re­laps­ing mul­ti­ple scle­ro­sis.

Back when the tri­al read out in 2017, up­beat an­a­lysts al­so ran their own cross-tri­al com­par­isons with No­var­tis’ Gilenya and con­clud­ed that Cel­gene might leap out on­to the mar­ket with a sim­i­lar ef­fi­ca­cy pro­file but bet­ter safe­ty fea­tures.

One of them, Bri­an Sko­r­ney of Baird, re­mains op­ti­mistic — if slight­ly more cau­tious. From a re­cent note:

Man­age­ment cit­ed that they ex­pect to re­sub­mit the NDA for ozan­i­mod in March, file for ap­proval of liso-cel in the sec­ond half of this year, and se­cure ap­proval of bb2121 by EOY 2020. We con­tin­ue to be­lieve that the even­tu­al ap­proval of these three as­sets with­in the giv­en time­lines is more like­ly than not. Based on the avail­able clin­i­cal in­for­ma­tion and the an­tic­i­pat­ed time­lines of the on­go­ing clin­i­cal tri­al pro­grams, our es­ti­mates for the like­li­hood of suc­cess of each as­set are ~75% for ozan­i­mod, ~90% for liso-cel, and ~85% for bb2121.

Fresh from a ma­jor late-stage im­plo­sion sur­round­ing mon­gersen, Cel­gene shook in­vestors when it dis­closed the RTF more than a year ago. The FDA, it said back then, had de­ter­mined “that the non­clin­i­cal and clin­i­cal phar­ma­col­o­gy sec­tions in the NDA were in­suf­fi­cient to per­mit a com­plete re­view.”

Then the com­pa­ny man­aged to at­tract side eyes again when a top ex­ec pinned the blame for the fi­as­co on Re­cep­tos, the orig­i­nal de­vel­op­er of the drug — which was bought out by Cel­gene 2.5 years be­fore the fil­ing, its ex-CEO point­ed out in re­sponse. In its glo­ry days, Cel­gene has said ozan­i­mod is worth $4 bil­lion to $6 bil­lion a year in peak sales, but that’s be­com­ing an in­creas­ing­ly tough pitch with an­a­lysts, es­pe­cial­ly with new safe­ty tri­als now un­der way rais­ing ques­tions about po­ten­tial drug-drug in­ter­ac­tions.

Cel­gene, mean­while, still “be­lieves ozan­i­mod could be a best-in-class, oral op­tion for use ear­ly in the treat­ment of re­laps­ing forms of mul­ti­ple scle­ro­sis,” CMO Jay Back­strom said in a state­ment.

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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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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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.