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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.