Ab­b­Vie antes up $225M in cash to buy in­to the Alzheimer's plat­form at Alec­tor

For well over a decade now, the ma­jor fo­cus in Alzheimer’s R&D has been con­cen­trat­ing heav­i­ly — though not ex­clu­sive­ly — on the tan­gles of tox­ic amy­loid be­ta and tau that are of­ten as­so­ci­at­ed with the dis­ease. Alec­tor set out to do things dif­fer­ent­ly, though, with a fo­cus on the in­nate im­mune re­sponse in the brain. Now as in­ves­ti­ga­tors for the lit­tle biotech aim for the clin­ic, Ab­b­Vie wants in, pay­ing a whop­ping $205 mil­lion in cash — with $20 mil­lion re­served for an up­com­ing round — and promis­ing an undis­closed mul­ti­ple in mile­stones to part­ner on the work.

Ab­b­Vie al­ready has an in-house pro­gram on tau. But look­ing a few years ahead to when the Hu­mi­ra fran­chise faces gener­ic com­pe­ti­tion, they’re dou­bling down on Alzheimer’s and a range of dis­eases that fall un­der the head­ing of neu­rode­gen­er­a­tion. A win here would be huge, and Ab­b­Vie is will­ing to bet big.

Robert Paul, Alec­tor

The way Alec­tor thinks of things, neu­rode­gen­er­a­tion and de­men­tia are caused by in­ac­tiv­i­ty of the im­mune sys­tem. And tak­ing a cue from im­muno-on­col­o­gy — where they have a sec­ondary, par­al­lel pro­gram in place — Alec­tor has been de­vel­op­ing a pre­clin­i­cal pipeline of an­ti­bod­ies that are de­signed to act to ei­ther ac­cel­er­ate the im­mune sys­tem or se­lec­tive­ly re­move the brakes that are in place.

If they’re right, the mi­croglia in the brain can go a long way to gob­bling up the tox­ic pro­teins that may be the cen­tral play­ers in dri­ving Alzheimer’s.

“We will go in­to the clin­ic a year from now, and we’re plan­ning to bring 5 drugs in­to the clin­ic in the next 18 months,” says Robert Paul, the chief med­ical of­fi­cer at Alec­tor.

Those drugs are com­ing di­rect­ly from Adimab, Till­man Gern­gross’s shop near Dart­mouth in New Hamp­shire. Gern­gross is the chair­man and co-founder at South San Fran­cis­co-based Alec­tor, which is run by Genen­tech vet­er­an Arnon Rosen­thal. And he’s had decades to per­fect new an­ti­bod­ies for the clients he works with, sell­ing turnkey an­ti­body de­vel­op­ment plat­forms to the ma­jor de­vel­op­ers in the in­dus­try or de­vis­ing pipelines for the biotechs he helps found.

In this new deal, Ab­b­Vie vaults from a ven­ture backer — help­ing to arrange the first $80 mil­lion in fund­ing — to a close col­lab­o­ra­tor. Ab­b­Vie will get an op­tion on two of Alec­tor’s ther­a­pies, which the biotech will take through proof-of-con­cept stud­ies. If Ab­b­Vie picks up its op­tions, they will then co-fund de­vel­op­ment in a dri­ve to com­mer­cial­ize the ther­a­pies — with a prof­it split for any­thing that gets ap­proved.

In ad­di­tion to the $205 mil­lion in cash, Ab­b­Vie is set­ting aside $20 mil­lion for an added eq­ui­ty stake in Alec­tor, which is con­cur­rent­ly rais­ing a big new round, with a syn­di­cate that in­cludes Mer­ck, Or­biMed, Po­laris, Mis­sion Bay Cap­i­tal and Top­spin Part­ners. The mile­stones are undis­closed, but in a pre­clin­i­cal deal that starts out with $225 mil­lion up front, they al­most cer­tain­ly run in­to 10 fig­ures.

Sabah Oney, Alec­tor

They’ll need the mon­ey. Neu­rode­gen­er­a­tion de­vel­op­ment does not come cheap, and Alec­tor wants to move a pipeline in­to the clin­ic, rather than just one or two can­di­dates.

Alec­tor and Ab­b­Vie al­so are acute­ly aware of the po­ten­tial here.

“If these drugs are suc­cess­ful, they are go­ing to be­come block­buster bi­o­log­ics,” says Sabah Oney, the head of busi­ness de­vel­op­ment at the biotech.

For the past 15 years, that block­buster bea­con has dri­ven a grow­ing slate of bit­ter Phase III fail­ures. The lat­est was at Ax­o­vant, a brash up­start that thought it could do what Glax­o­SmithK­line and ri­vals had tried by amp­ing up neu­ro­trans­mit­ters. Eli Lil­ly had three straight de­feats with solanezum­ab, and still hasn’t giv­en up on it. And now BACE and oth­er strate­gies are be­ing put to the test, with ear­ly fail­ures point­ing to the po­ten­tial for more dis­as­ter as well.

Still, Bio­gen’s mixed suc­cess with ad­u­canum­ab has em­bold­ened many of the big play­ers, like Roche, to go back to the draw­ing board.

Alec­tor and Ab­b­Vie want to try some­thing dif­fer­ent now, and it will take years to see if it works.

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.

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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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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J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.

Fresh analy­sis spot­lights car­dio ben­e­fit of J&J's In­vokana in di­a­betes pa­tients with­out his­to­ry of CV dis­ease

In­vokana sales may be mut­ed, but the di­a­betes drug is set to get some love af­ter its mak­er J&J un­veiled da­ta at the Amer­i­can Di­a­betes As­so­ci­a­tion meet­ing on Tues­day sug­gest­ing the med­i­cine can con­fer a car­dio­vas­cu­lar ben­e­fit in pa­tients who do not have pre­ex­ist­ing CV dis­ease.

Back in April, J&J had re­port­ed that in the late-stage CRE­DENCE study, the SGLT2 drug scored a 30% re­duc­tion in the risk of a com­pos­ite of ail­ments: a pro­gres­sion to the dou­bling of serum cre­a­ti­nine, end-stage kid­ney dis­ease and re­nal or car­dio­vas­cu­lar death. In terms of sec­ondary end­points, the drug was al­so found be heart-pro­tec­tive: low­er­ing the risk of CV death and hos­pi­tal­iza­tion for heart fail­ure by 31%, as well as ma­jor ad­verse CV events by 20%. In March, the com­pa­ny sub­mit­ted an ap­pli­ca­tion to ex­pand In­vokana’s la­bel to re­flect its im­pact on chron­ic kid­ney dis­ease.

Sil­i­con Val­ley's most an­tic­i­pat­ed slide deck just dropped. What does it mean for bio­phar­ma's dig­i­tal teams?

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.