Pos­i­tive oc­u­lar im­plant da­ta bring Al­ler­gan one step clos­er to NDA; Vivek Ra­maswamy spawns an­oth­er 'Van­t'

→  In 2016, Brent Saun­der’s Al­ler­gan $AGN or­ches­trat­ed a string of deals af­ter its $160 bil­lion merg­er with Pfiz­er fell through thanks to Oba­ma-era tax rules, in­clud­ing For­Sight VI­SION5 and its glau­co­ma tech­nol­o­gy for $95 mil­lion up­front. But Al­ler­gan al­so has its own in­ter­nal­ly de­vel­oped oph­thal­mol­o­gy pro­gram, its oc­u­lar im­plant bi­mato­prost SR is de­signed to help low­er in­traoc­u­lar pres­sure for at least 4 months in pa­tients strug­gle with eye drops. On Mon­day, Al­ler­gan said a sec­ond Phase III study demon­strat­ed pos­i­tive da­ta adding to the re­sults of a late-stage study re­port­ed in June 2018. An NDA is slat­ed to be sub­mit­ted in the sec­ond half of 2019.

→ Vivek Ra­maswamy has an­nounced the launch of yet an­oth­er “Vant.” This one is called Aly­vant, and its tech is de­signed to help phar­ma­ceu­ti­cal com­pa­nies in­te­grate mar­ket re­search, sales force op­ti­miza­tion, and dig­i­tal en­gage­ment in­to a sin­gle plat­form to con­nect pa­tients and physi­cians with rel­e­vant med­i­cines cost-ef­fec­tive­ly. The com­pa­ny, led by in­dus­try vet­er­an Gillian Can­non, al­ready has an agree­ment with an un­named phar­ma­ceu­ti­cal part­ner to co-pro­mote three ap­proved brand­ed drugs. “This tech­nol­o­gy plat­form al­lows us to en­gage new mar­ket seg­ments that are un­der­served by tra­di­tion­al phar­ma com­mer­cial mod­els, while al­so re­duc­ing the need for ex­pen­sive and waste­ful mass-mar­ket DTC cam­paigns that in­flate the cost of de­liv­er­ing new med­i­cines to pa­tients,” said Ben­jamin Zim­mer, pres­i­dent of par­ent com­pa­ny Roivant Health, in a state­ment.

→ You may re­mem­ber Myr­i­ad Ge­net­ics from its le­gal fight with Tesaro over the ne­ces­si­ty of its di­ag­nos­tic as a com­pan­ion to the biotech’s PARP in­hibitor. But as in­ves­tiga­tive jour­nal­ist Rod­dy Boyd (of Valeant fame) writes in his lat­est ex­posé for South­ern In­ves­tiga­tive Re­port­ing Foun­da­tion, it was not the com­pa­ny’s on­ly ge­net­ic test that proved fu­tile.

Boyd’s sev­en-month in­ves­ti­ga­tion cen­tered around Gen­e­Sight, a di­ag­nos­tic that promis­es to guide a psy­chi­a­trist in se­lect­ing an an­ti­de­pres­sant by an­a­lyz­ing a pa­tient’s ge­net­ic pro­file. Put sim­ply: It didn’t work — failed the pri­ma­ry end­point and 23 out of 25 sec­ondary ones — but the ex­ecs spinned it as if it did, kick­ing stock prices up. It was, in Boyd’s words, a demon­stra­tion of the “com­pa­ny’s abil­i­ty to spin ever more fan­tas­ti­cal non­sense — and to bril­liant­ly nav­i­gate the opaque line be­tween re­quired dis­clo­sure and mis­di­rec­tion.”

But that’s not all. In a sep­a­rate sto­ry, Boyd re­ports that in 2013, Myr­i­ad Ge­net­ics avoid­ed a cut to the re­im­burse­ment lev­el by the Cen­ters for Medicare and Med­ic­aid Ser­vices thanks to an ag­gres­sive lob­by­ing cam­paign by a staffer work­ing for Sen. Or­rin Hatch. The Salt Lake City-based com­pa­ny’s close re­la­tion­ship with the long-serv­ing Utah sen­a­tor, he wrote, helped Myr­i­ad win in six months a reg­u­la­to­ry break that could have tak­en years. Add that to an ap­par­ent billing loop­hole that Myr­i­ad had seized for its breast can­cer-re­lat­ed gene test, and you get mil­lions in added rev­enue at a time in­creased com­pe­ti­tion is dri­ving prices down for ge­net­ic test­ing, ac­cord­ing to Boyd.

(Ed­i­tor’s note: Af­ter this item ap­peared Mon­day, a spokesper­son for Myr­i­ad Ge­net­ics con­tact­ed End­points News and of­fered this in re­sponse: “Myr­i­ad dis­putes (the) ac­cu­ra­cy of Mr. Boyd’s ar­ti­cles.”)

→ Fre­quen­cy Ther­a­peu­tics — which is fo­cused on cre­at­ing a new class of drugs based on small mol­e­cule stim­u­la­tion of dor­mant stem cells with­in the body to re­pair dis­eased or dam­aged tis­sue — closed $42 mil­lion in Se­ries B round, bring­ing funds raised in to­tal to $87 mil­lion. The cap­i­tal will be used to fi­nance the de­vel­op­ment of its ex­per­i­men­tal drug, FX-322, for hear­ing re­gen­er­a­tion. Top-line re­sults from an on­go­ing Phase 1/2 study are ex­pect­ed in the first half of 2019.

→ Blue­bird bio $BLUE has joined forces with In­hi­brx to co-de­vel­op CAR-T cell ther­a­pies us­ing In­hi­brx’s sin­gle do­main an­ti­body (sdAb) plat­form for mul­ti­ple can­cer tar­gets. In­hi­brx gets $7 mil­lion up­front, and is el­i­gi­ble to re­ceive un­spec­i­fied funds in mile­stones pay­ments.

→ Pfiz­er $PFE has tied up with Cy­toRe­a­son — a ma­chine learn­ing com­pa­ny for drug dis­cov­ery and de­vel­op­ment —for an undis­closed sum.Cy­toRe­a­son’s plat­form has the po­ten­tial to of­fer valu­able in­sights that may be ap­plied to our re­search in­to the hu­man im­mune sys­tem,” said Pfiz­er’s Michael Vin­cent, CSO for in­flam­ma­tion & im­munol­o­gy, in a state­ment.

→ Gala­pa­gos $GLPG is pair­ing up with pri­vate­ly held Fi­bro­cor to fo­cus on id­io­path­ic pul­monary fi­bro­sis and oth­er in­di­ca­tions. The two are work­ing to­geth­er on a small mol­e­cule in­hibitor pro­gram for an undis­closed tar­get, as part of the deal with undis­closed fi­nan­cial terms an­nounced on Fri­day.

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.