Biogen extends its setback streak as Japanese regulators push back against their controversial Alzheimer’s drug

An­oth­er bad week for Bio­gen and its Tokyo-based part­ners at Ei­sai was ex­tend­ed on Wednes­day with news that a pan­el re­view of their con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab earned a push­back from the health min­istry in Japan.

Ac­cord­ing to overnight news re­ports, their pan­el con­clud­ed that in­con­sis­tent Phase III da­ta and lack of clin­i­cal sig­nif­i­cance in re­duc­ing amy­loid plaque in pa­tients made it dif­fi­cult to de­ter­mine if the ther­a­py worked, but of­fered to re­view it again once the 2 part­ners lined up more da­ta.

That lat­est push­back comes just days af­ter Bio­gen and Ei­sai were forced to dig a de­fen­sive perime­ter around the for­mal Eu­ro­pean reg­u­la­to­ry de­ci­sion against an ap­proval and right on the heels of Bio­gen’s de­ci­sion to slash the US price and be­gin a com­pa­ny re­or­ga­ni­za­tion as sales stag­nate in the face of deeply em­bed­ded re­sis­tance to the drug — which of­fered one of the most con­tro­ver­sial ap­provals in FDA his­to­ry.

Bio­gen says it’s not giv­ing up on Japan. In a state­ment sent to End­points News, a spokesper­son not­ed:

The com­pa­nies will con­tin­ue to ac­tive­ly en­gage with the Phar­ma­ceu­ti­cals and Med­ical De­vices Agency (PM­DA) in Japan to agree on ad­di­tion­al da­ta re­quire­ments. Bio­gen and Ei­sai re­main com­mit­ted to bring­ing ad­u­canum­ab to pa­tients in Japan ex­pe­di­tious­ly.

Japan was seen as a pos­si­ble op­por­tu­ni­ty to stop some of the bleed­ing over the dis­as­trous roll­out, with Ei­sai deeply en­trenched in the coun­try and look­ing to mar­ket what it and its part­ners in­sist is the first dis­ease-mod­i­fy­ing drug for Alzheimer’s. Ei­sai spear­head­ed the reg­u­la­to­ry ef­fort in Japan and stood to earn the li­on’s share of the mon­ey from the big Asian mar­ket.

Ex­perts, though, have shak­en their heads in uni­son over a mud­dle of con­flict­ing da­ta, per­plexed that the FDA would of­fer an ac­cel­er­at­ed ap­proval based on the sus­pect the­o­ry that amy­loid re­duc­tion would like­ly help pa­tients fight back against the steady drain of their mem­o­ries.

Those ex­perts show no sign of go­ing away, as we al­so saw this week with a line­up of re­searchers in the field who signed a pe­ti­tion de­mand­ing the FDA pro­vide an ac­cel­er­at­ed with­draw­al of the drug from the US mar­ket.

As of to­day, the FDA re­mains the sole pre­mier drug agency in the world that thinks the drug should be on the mar­ket, based on what we know so far.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

Khurem Farooq, Gyroscope CEO

Christmas is coming early for Gyroscope.

In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.

Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.

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Angie You and Volker Schellenberger, Amunix

Sanofi is crashing the year-end M&A party with a deal of its own.

Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’

‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’

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Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.

‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’

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As the FDA is poised to authorize the new Pfizer and Merck pills to treat those with Covid-19 who haven’t been hospitalized, Bloomberg reports that the US will only have limited supplies of each pill initially.

US officials said Americans should have nearly 400,000 courses of Merck’s pill available upon its authorization and 65,000 courses of Pfizer’s pill. By the end of January, the government expects 3 million Merck courses — its entire order — and 250,000 Pfizer courses. Merck’s pill has been shown to be less effective in early trials than Pfizer’s, although Merck did not test its pill head-to-head against Pfizer.

Graphic: Alexander Lefterov for Endpoints News

Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.

In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.

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Michael Yang, ViaCyte CEO

Over the last 20 years, ViaCyte — under one name or another — has pursued one of the most audacious goals in biotech: a cure for type 1 diabetes.

The company’s plan was to take lab-grown stem cells and turn them into the insulin-producing cells that are destroyed in T1D patients. The first attempt to implant these cells into patients in 2014 failed entirely. But the San Diego biotech regrouped and launched trials for a new candidate in 2017, raising $80 million in the process.

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Harvard University professor Charles Lieber leaves federal court, Tuesday, Dec. 14, 2021, in Boston (Michael Dwyer/AP Images)

In a stunning climax to an eye-catching saga, Harvard scientist Charles Lieber has been convicted of lying to the federal government about his ties to China’s Thousand Talents Program.

Following close to three hours of deliberation, a federal jury in Boston found 62-year-old Lieber — a pioneer in medical nanotechnology and the former chair of Harvard’s chemistry department — guilty of all six felony charges, including two counts of making false statements, two counts of filing false tax returns and two counts of failing to disclose a foreign (in this case Chinese) bank account.

Rashad Burgess, head of Gilead Sciences’ HIV community operations

The Covid pandemic set back progress in another pandemic, HIV, to devastating effect. Few likely know that as well as Rashad Burgess, the head of Gilead Sciences’ HIV community operations and overseeing the pharma company’s local ambassadors in cities across the US.

For the first time in 40 years, there were months when more people were dropping out of HIV treatment than enrolling, Burgess said. The prevalence is particularly pronounced in the South, which even before the pandemic accounted for 51% of new HIV diagnoses, according to the CDC – and its only gotten worse in the past 21 months.
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