As back­lash mounts in the wake of a dis­as­trous PhI­II flop, Ei­sai goes deep­er with 2 new hires

While Bio­gen buck­les un­der in­tense crit­i­cism for the Phase III fail­ure of ad­u­canum­ab for Alzheimer’s — trig­ger­ing a re­view of what it should fo­cus on next — its long­time neu­ro­sciences part­ner Ei­sai con­tin­ues to build its in­vest­ment in their con­tro­ver­sial R&D work.

The bio­phar­ma play­er has re­cruit­ed a pair of se­nior ex­ecs to join the Alzheimer’s team at Ei­sai, which stirred a con­sid­er­able fuss with a ham-hand­ed de­ci­sion to start a Phase III tri­al for BAN2401 right af­ter Bio­gen was forced to try and ex­plain the ad­u­canum­ab flop — af­ter build­ing their late-stage pipeline around that project.

Har­ald Ham­pel

Not­ing that the com­pa­ny is deep­en­ing its com­mit­ment to Alzheimer’s, Ei­sai wooed Har­ald Ham­pel to join the com­pa­ny as vice pres­i­dent, glob­al med­ical af­fairs while Michael Irizarry has been named vice pres­i­dent, clin­i­cal re­search. Both will take lead­ing roles on the Alzheimer’s pro­grams.

Ham­pel is com­ing from the Sor­bonne while Irizarry is jump­ing on af­ter com­plet­ing a stint at Eli Lil­ly, which has suf­fered its own late-stage fi­as­coes in Alzheimer’s over the years — most promi­nent­ly with solanezum­ab and more re­cent­ly with the failed Phase III BACE ef­fort.

Michael Irizarry

Ei­sai and Bio­gen are still work­ing to­geth­er on BAN2401, for now at least, as that pro­gram has weaved from one con­tro­ver­sy to the next. First it was a Phase II fail­ure, then re­searchers claimed a suc­cess be­fore an­a­lysts pounced on a tri­al de­sign fea­ture forc­ing out high-risk pa­tients that may have skewed the re­sults.

They’re al­so still part­nered on the oral BACE drug elen­be­ce­s­tat, even though they’ve nev­er tracked cog­ni­tive re­wards from the drug, which fits in­to a field that has seen a pair of de­ci­sive Phase III fail­ures at Mer­ck and Eli Lil­ly/As­traZeneca.

Both drugs are aimed square­ly at amy­loid be­ta, a tox­ic sub­stance that of­ten ac­cu­mu­lates in the brains of pa­tients. But af­ter in­dus­try play­ers spent bil­lions of dol­lars on the the­o­ry, there’s no da­ta to sug­gest that it works. Now some promi­nent an­a­lysts are de­mand­ing that Bio­gen back off and steer a new di­rec­tion, while Ei­sai con­tin­ues to plow its own course.

Ei­sai has been build­ing a be­spoke, $100 mil­lion R&D cen­ter in the Cam­bridge/Boston hub for its Alzheimer’s work. 

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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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.