Ei­sai launch­es biotech di­vi­sion in Mass­a­chu­setts aimed at Alzheimer’s, I/O and au­toim­mune dis­eases

Ei­sai is tack­ling Alzheimer’s, au­toim­mune dis­eases and the tu­mor mi­croen­vi­ron­ment with a new “biotech-like” re­search unit in An­dover, MA that has al­ready brought to­geth­er 90 re­searchers whose ex­per­tise cuts across a va­ri­ety of dis­ci­plines.

The new unit has been dubbed the Ei­sai An­dover in­no­v­a­tive Med­i­cines (AiM) In­sti­tute, which is op­er­at­ing in a 220,000-square foot fa­cil­i­ty. And it’s mak­ing ex­ter­nal col­lab­o­ra­tions with the ex­ten­sive sci­en­tif­ic and biotech com­mu­ni­ty in the big Boston hub a top pri­or­i­ty.

The Japan­ese phar­ma com­pa­ny in­tends for the in­sti­tute’s in­ves­ti­ga­tors to ex­plore im­mune dys­func­tion and the role of neu­roim­mune tar­gets for con­trol­ling de­men­tia, and specif­i­cal­ly Alzheimer’s, look­ing to new ge­net­ics re­search to help guide their dis­cov­ery and de­vel­op­ment work. Ei­sai al­so plans to fol­low up on its de­vel­op­ment work for E7046, an oral EP4 re­cep­tor ag­o­nist, for its im­muno-on­col­o­gy ef­forts. And there will be a pro­gram for small mol­e­cules that tar­get toll-like re­cep­tors and prostaglandins for au­toim­mune dis­eases, start­ing with lu­pus.

The new in­sti­tute is in­tend­ed to be a unique­ly struc­tured dis­cov­ery group, says Nadeem Sar­war, the group chief at Ei­sai who ear­li­er com­plet­ed a stint as an aca­d­e­m­ic re­searcher at the Uni­ver­si­ty of Cam­bridge.

“We’ve been set up to ex­clu­sive­ly re­al­ize hu­man ge­net­ics drug dis­cov­ery,” Sar­war tells me this morn­ing.

Sar­war un­der­stands full well that Alzheimer’s in par­tic­u­lar has de­fied in­ves­ti­ga­tors en­gaged in mas­sive­ly ex­pen­sive re­search projects. So Ei­sai has de­cid­ed to see if it can change the par­a­digm “and take a fun­da­men­tal­ly dif­fer­ent ap­proach.”

All of their fo­cus will cen­ter on im­mune dys­func­tion, he says, with an ex­clu­sive aim at nov­el tar­gets val­i­dat­ed by hu­man ge­net­ics tech­nol­o­gy.

“Drug tar­gets sup­port­ed by hu­man ge­net­ics are twice as like­ly to be suc­cess­ful,” says Sar­war. And his group will be work­ing on im­mune dys­func­tion un­der the neu­rol­o­gy arm of the com­pa­ny, which is set up to march through a prover­bial­ly seam­less sys­tem from dis­cov­ery through com­mer­cial­iza­tion.

Sar­war has al­ready re­cruit­ed com­pa­ny re­searchers as well as out­side ex­perts to the new ef­fort, with the staff of 90 in place. And he plans to add to that, though he can’t say right now just how large the op­er­a­tion will grow ul­ti­mate­ly. An­dover of­fered a site with ded­i­cat­ed lab space that Sar­war need­ed, and he says he’s not very far from the Cam­bridge clus­ter, where Ei­sai will be ac­tive­ly look­ing to part­ner with acad­e­mia, phar­ma, CROs and oth­ers as they look to aug­ment their own tech­nolo­gies and pro­vide ac­cess to oth­ers work­ing in the same fields.

Ei­sai’s de­ci­sion to fo­cus on the Boston hub fol­lows a trend al­ready well de­fined by a group of phar­ma gi­ants like Pfiz­er and Mer­ck, which have been mi­grat­ing R&D di­vi­sions in­to the glob­al biotech clus­ter. The Japan­ese com­pa­nies haven’t ig­nored that trend. Take­da re­cent­ly an­nounced its own plans to con­cen­trate more work in the Boston hub as it down­sizes in the UK and oth­er spots, trans­fer­ring 300 staffers to a CRO in the process.

They’re all hop­ing to pol­li­nate new drugs with what they hope is a more pro­duc­tive ap­proach to de­vel­op­ment.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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