Go­ing all in: Bio­gen com­mits an ex­tra $500M to Alzheimer’s block­buster hope­ful ad­u­canum­ab

Bio­gen CEO Michel Vounatsos is go­ing all in on his late-stage Alzheimer’s drug ad­u­canum­ab.

Michel Vounatsos, Bio­gen

The big biotech said to­day that it paid Neurim­mune, which out-li­censed the drug to Bio­gen, $150 mil­lion to cut its ne­go­ti­at­ed roy­al­ty rate for post-ap­proval sales by 15%. And it’s pre­pared to pay an­oth­er $50 mil­lion for an­oth­er 5% rate re­duc­tion.

The $200 mil­lion deal comes on top of yes­ter­day’s an­nounced plan to re­struc­ture Bio­gen’s part­ner­ship with Ei­sai on ad­u­canum­ab, which one promi­nent an­a­lyst ex­pects will cost Bio­gen about $300 mil­lion in added re­search costs.

In that re­vi­sion, Bio­gen upped its US and Eu­ro­pean share of the prof­its by 5% and 18.5% re­spec­tive­ly. Ei­sai, which opt­ed in ear­ly on the deal, will now get 80% of the Japan­ese mar­ket, says Leerink’s Ge­of­frey Porges.

In­vestors didn’t seem too thrilled by that switchup, though, with Bio­gen’s shares sink­ing about 3% on Mon­day.

Ge­of­frey Porges, Leerink

Com­ment­ing on the Ei­sai deal, Porges not­ed:

This agree­ment is a sur­prise and has oc­curred out­side the two dis­closed opt-in time win­dows for Ei­sai…Al­though the re­duc­tion in Bio­gen’s Japan prof­it split from 50% to 20% may seem triv­ial com­pared to the US and EU rights, block­buster Alzheimer’s med­i­cines such as Ari­cept and Na­men­da have earned 20-25% of their peak glob­al rev­enue from the Japan­ese mar­ket, while the EU has con­tributed on­ly ~10%. How­ev­er, the price dy­nam­ics have changed quick­ly in Japan since these peak sales fig­ures were achieved in 2010 and 2015, and we note mul­ti­ple in­stances of drug man­u­fac­tur­ers be­ing re­quired to re­im­burse the Japan­ese gov­ern­ment and slash prices for block­buster drugs (Har­voni, Avastin, Plav­ix) that sell over a cer­tain rev­enue thresh­old. Bio­gen ap­pears will­ing to leave the ma­jor­i­ty of this mar­ket to Japan­ese-domi­ciled Ei­sai, who are like­ly bet­ter equipped to han­dle these chang­ing dy­nam­ics.

Bio­gen is ad­vanc­ing a drug that has helped reignite the kind of fer­vor that drove a long line­up of ma­jor Phase II­Is, which all crashed against the rocks over the last 15 years. By tar­get­ing amy­loid be­ta, the biotech has been able to demon­strate some pos­i­tive re­sults for high-risk pa­tients in ear­ly stud­ies. But this is any­thing but a sure shot.

ARIA is al­so a clear threat. The in­ci­dence of ARIA-E in ApoE4 car­ri­ers in the fixed-dose arms at one stage was 5 per­cent in the 1 mg/kg and 3 mg/kg arms, 43 per­cent in the 6 mg/kg arm and 55 per­cent in the 10 mg/kg arm. The in­ci­dence of ARIA-E in ApoE4 car­ri­ers in the titra­tion arm was 35 per­cent.

Now in late-stage test­ing, Bio­gen CEO Vounatsos is bet­ting his rep­u­ta­tion on suc­cess.

“This amend­ed agree­ment with Neurim­mune im­proves ad­u­canum­ab’s po­ten­tial val­ue to Bio­gen as we pur­sue our strate­gic goal of lead­er­ship in Alzheimer’s dis­ease,” says Vounatsos.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.


Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.


Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Adding mar­quee in­vestors, Black­Thorn bags $76M to back an AI-dri­ven strat­e­gy for pre­ci­sion neu­ro med­i­cine

As ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing loom ever larg­er in drug dis­cov­ery and de­vel­op­ment, a biotech op­er­at­ing at the “nexus” of tech­nol­o­gy and neu­ro­sciences has cashed in with $76 mil­lion in fresh fi­nanc­ing.

The big idea at Black­Thorn Ther­a­peu­tics is to do for neu­robe­hav­ioral dis­or­ders what ge­net­i­cal­ly tar­get­ed ther­a­py has done for on­col­o­gy: Re­de­fine pa­tient pop­u­la­tions by the un­der­ly­ing bi­ol­o­gy — dys­reg­u­lat­ed brain cir­cuits, or neu­rotypes — in­stead of symp­toms, there­by find­ing the pa­tients who are most like­ly to ben­e­fit at en­roll­ment phase.

Savara shares are crushed as PhI­II tri­al flunks pri­ma­ry, key sec­on­daries — but they can’t stop be­liev­ing

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.