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. 

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

AbbVie is donating more than $1 million worth of an HIV drug to help combat the fast-spreading coronavirus outbreak in China, the company announced on Friday.

China’s National Health Commission has suggested Aluvia, a pill containing lopinavir and ritonavir, as one of two possible treatments for the symptoms of the virus currently known as 2019-nCoV in the absence of effective antiviral medications. The other part is nebulized alpha-interferon.

Ab­b­Vie and Al­ler­gan di­vesti­tures are in, and an old As­traZeneca drug comes home

When AbbVie announced their $63-billion Allergan acquisition last year, executives acknowledged the two companies would have to divest some drugs to satisfy regulators. The two main assets in discussion have now been sold off – and one of them is coming home.

AstraZeneca will acquire brazikumab, Allergan’s late-stage IL-23 candidate for Crohn’s disease and ulcerative colitis. The drug was originally developed by AstraZeneca’s defunct subsidiary MedImmune, in collaboration with Amgen. Allergan licensed it for $250 million upfront and $1.27 billion in milestones.

As­traZeneca makes case for use of blood thin­ner Bril­in­ta in stroke pa­tients

AstraZeneca’s extravagant projections for its clot fighter Brilinta may have fizzled in the face of underwhelming trial data — but a new pivotal study is set to expand its use substantially.

On Monday, the British drugmaker said the drug, when taken in conjunction with aspirin, induced a statistically significant reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone, in 11,000 patients that have suffered minor acute ischaemic stroke or a high-risk transient ischemic attack (TIA).

Samantha Truex (file photo)

Bruce Booth and Saman­tha Truex's lat­est ven­ture aims just above Hu­mi­ra

In 2000, about a year after the first trial data on Humira came out, a Japanese team identified a new gene that appeared to prevent GI cancer in mice: gasdermin, they called it, after the particular proteins it expressed.

Over the next decade-and-a-half, scientists found five more genes in the same family – often identified as gasdermin A, B, C, D, E and F – and yet their purpose baffled scientists. Mutations in A appeared to make mice bald (alopecia), but deleting it had no effect. Mutations in F and A were linked to deafness. Mutant E caused human cells to self-destruct.

FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back — this time flunk­ing fu­til­i­ty test — as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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