Al­ler­gan set to make head­way in crowd­ed CGRP mi­graine mar­ket, as the bat­tle for for­mu­la­ry cov­er­age be­gins

Mil­lions of mi­graine suf­fer­ers could soon get their hands on an oral CGRP drug de­signed to be used as-need­ed, as Al­ler­gan $AGN on Wednes­day said it was on track to file for FDA ap­proval for ubro­gepant in the first quar­ter of next year. The mul­ti-bil­lion dol­lar mi­graine mar­ket is al­ready re­plete with in­jectable med­ica­tions from Te­va $TE­VA, Eli Lil­ly $LLY, and one from Am­gen $AMGN and No­var­tis $NVS, which are all de­signed to be used as pre­ven­ta­tive treat­ments and are cu­ri­ous­ly priced iden­ti­cal­ly.

Last month, Lil­ly se­cured FDA ap­proval for its in­jec­tion Em­gal­i­ty, af­ter the agency grant­ed sim­i­lar ap­provals to Aimovig from Am­gen Inc and No­var­tis, and Te­va’s Ajovy. All three drugs large­ly work in a sim­i­lar man­ner and have demon­strat­ed a sig­nif­i­cant re­duc­tion in mi­graine fre­quen­cy in about half of pa­tients when test­ed in clin­i­cal stud­ies. In­ter­est­ing­ly, each drug­mak­er has al­so priced their of­fer­ings at a list price of $6,900 a year, or $575 per month.

But ear­li­er on Wednes­day, Reuters re­port­ed that the hefty US phar­ma­cy ben­e­fit man­ag­er Ex­press Scripts $ES­RX had de­cid­ed to cov­er new mi­graine drugs from Lil­ly and Am­gen as part of its for­mu­la­ry and ex­clude Te­va, fol­low­ing ne­go­ti­a­tions with all three man­u­fac­tur­ers.

“This puts more pres­sure on Te­va to score for­mu­la­ry wins in the oth­er larg­er plans, which at this point may still be up for grabs. We es­ti­mate peak share of 20% for Ajovy but ac­knowl­edge it will be im­per­a­tive for it to get 1-2 ma­jor wins to get there,” Leerink an­a­lysts wrote in a note.

Te­va shares are down 5%.

A spokesper­son from Al­ler­gan told End­points News that it was pre­ma­ture to com­ment on ubro­gepant’s pric­ing and pay­er dis­cus­sions as the com­pa­ny has not yet filed its mar­ket­ing ap­pli­ca­tion, and that it could not com­ment on its plans for an EMA fil­ing at this time.

Ac­cord­ing to the Mi­graine Re­search Foun­da­tion, mi­graine is the third most preva­lent ill­ness in the world, af­fect­ing about 39 mil­lion in the Unit­ed States and some 1 bil­lion world­wide. The mar­ket for mi­graine drugs is ex­pect­ed to hit $8.7 bil­lion by 2026, ac­cord­ing to Glob­al­da­ta.  Be­fore the slate of ap­provals this year, pa­tients were large­ly treat­ed with a host of drugs in­clud­ing an­ti-de­pres­sants, hy­per­ten­sion med­i­cines and a class of drugs called trip­tans. This new class of bi­o­log­ics, known as CGRP (cal­ci­tonin gene-re­lat­ed pep­tide) in­hibitors, tar­get the CGRP pro­tein that trans­mits pain sig­nals in­to the brain, and is be­lieved to be in­stru­men­tal in gen­er­at­ing and main­tain­ing headaches as­so­ci­at­ed with mi­graine.

For those pa­tients who still ex­pe­ri­ence mi­graine at­tacks while on pre­ven­ta­tive an­ti-CGRP ther­a­py, acute, as-need­ed treat­ments will still be re­quired, which is where Al­ler­gen’s ubro­gepant, which the com­pa­ny ac­quired from Mer­ck $MRK in 2015, could come handy.

If ap­proved, ubro­gepant could po­ten­tial­ly be used in com­bi­na­tion with its an­ti-CGRP in­jectable ri­vals and/or Al­ler­gan’s own ver­sa­tile Botox in­jec­tion, which has been ap­proved for mi­graine pre­ven­tion since 2010.

Al­ler­gan has al­ready re­port­ed pos­i­tive Phase III da­ta on ubro­gepant from two stud­ies ear­li­er this year, and on Wednes­day said that two oth­er stud­ies fur­ther eval­u­at­ing the drug’s safe­ty and tol­er­a­bil­i­ty, in­clud­ing one which eval­u­at­ed the po­ten­tial of he­pat­ic tox­i­c­i­ty in healthy pa­tients, meant that it was on track to file in Q1, 2019. Mi­graine drug de­vel­op­er, Bio­haven $BHVN, how­ev­er is do­ing their safe­ty study in mi­graine pa­tients, as Ever­core’s Umer Raf­fat points out.

Both Bio­haven and Alder $AL­DR are poised to sub­mit their mi­graine drugs for mar­ket­ing ap­proval next year.

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.