Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

Seiz­ing Aduhelm prece­dent, Bio­gen, Ei­sai get the ball rolling on an­oth­er ac­cel­er­at­ed Alzheimer's ap­proval

Bio­gen — to­geth­er with part­ners at Ei­sai — will be the first to breeze down that Alzheimer’s trail it blazed with the FDA’s his­toric and con­tro­ver­sial ac­cel­er­at­ed ap­proval of Aduhelm.

Ei­sai dis­closed it’s ini­ti­at­ed a rolling BLA sub­mis­sion for lecanemab, or BAN2401, the an­ti-amy­loid be­ta an­ti­body that Bio­gen has long tout­ed as a fol­low-on to Aduhelm (then ad­u­canum­ab). Fol­low­ing the prece­dent that the agency has now set, the two com­pa­nies are gun­ning for an OK based on da­ta sug­gest­ing that the drug could low­er amy­loid be­ta plaques.

They won’t be alone in the queue for long. Roche and Eli Lil­ly are hot on their heels to join the gold rush, with the lat­ter hav­ing al­so pledged to file by the end of the year.

Un­like with Aduhelm, whose ap­proval was ce­ment­ed by mixed da­ta viewed neg­a­tive­ly by the FDA’s ad­vi­so­ry com­mit­tee, the lecanemab fil­ing on­ly comes with Phase IIb da­ta, in­clud­ing those from the open-la­bel ex­ten­sion. The tri­al, dubbed Study 201, en­rolled 856 pa­tients with ear­ly Alzheimer’s and con­firmed amy­loid pathol­o­gy.

“The lecanemab Clar­i­ty AD Phase 3 clin­i­cal tri­al in ear­ly AD is on­go­ing and com­plet­ed en­roll­ment in March 2021 with 1,795 pa­tients,” Ei­sai wrote in a state­ment. “The U.S. FDA has agreed that the re­sults of Clar­i­ty AD, when com­plet­ed, can serve as the con­fir­ma­to­ry study to ver­i­fy the clin­i­cal ben­e­fit of lecanemab. Blind­ed safe­ty da­ta from Clar­i­ty AD will be in­clud­ed to sup­port the BLA.”

A spokesper­son added the pri­ma­ry end­point read­out for Clar­i­ty AD is ex­pect­ed in late 2022.

Dis­cus­sions go at least as far back as Au­gust, when Ei­sai R&D chief Ivan Che­ung told an­a­lysts his team had start­ed talk­ing to the FDA and seek­ing its ad­vice on sub­mit­ting lecanemab to the agency. Weeks be­fore that, the drug was grant­ed break­through ther­a­py des­ig­na­tion by the agency.

If lecanemab does fol­low in the path of Aduhelm and nab an ex­pe­dit­ed green light, it would fur­ther test the lim­its of pay­ers and doc­tors, who have al­ready proven much less wel­com­ing to Aduhelm than reg­u­la­tors (or at least the neu­ro di­vi­sion) were. As End­points News first re­port­ed, the VA de­cid­ed against in­clud­ing the drug in its for­mu­la­ry. Cer­tain pri­vate in­sur­ers have re­port­ed­ly de­clined to cov­er the drug, pend­ing the na­tion­al cov­er­age de­ci­sion by CMS; some treat­ment cen­ters say they won’t ad­min­is­ter the drug, and more re­cent­ly, one cen­ter in Wash­ing­ton, DC even banned Bio­gen rep­re­sen­ta­tives from the premis­es.

ICER, a drug pric­ing watch­dog, added an­oth­er loud voice to the cho­rus by blast­ing Aduhelm’s $56,000 price tag — amid a slate of in­ves­ti­ga­tions where law­mak­ers de­mand­ed an­swers on how the drug was ap­proved.

All of that has trans­lat­ed in­to a painful­ly slow roll­out, which Bio­gen CEO Michel Vounatsos blamed in part on “mis­in­for­ma­tion,” con­fu­sion and neg­a­tive me­dia cov­er­age.

Vounatsos said in the lat­est press re­lease: “It is our vi­sion that pa­tients and their fam­i­lies have choice and ac­cess to mul­ti­ple treat­ment op­tions for Alzheimer’s dis­ease.”

While Aduhelm is de­signed to clear in­sol­u­ble amy­loid plaques, lecanemab most­ly tar­gets sol­u­ble protofib­rils — larg­er oligomers thought to con­tribute to the neu­rode­gen­er­a­tion char­ac­ter­is­tic of Alzheimer’s.

So far, it’s been po­si­tioned for pa­tients with ear­ly Alzheimer’s, mean­ing those with mild cog­ni­tive im­pair­ment due to the dis­ease or mild forms of it.

“We rec­og­nize the strong and ur­gent ex­pec­ta­tions from stake­hold­ers to fur­ther ad­vance a treat­ment sys­tem for this dis­ease,” Ei­sai CEO Haruo Naito said.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

In­cyte yanks EU ap­pli­ca­tion for PD-1 drug, cit­ing in­abil­i­ty to an­swer reg­u­la­tors' 'ma­jor con­cern­s'

Hoping to wedge its way into a crowded PD-(L)1 field, Incyte faced a huge setback when the FDA sent back its application for an initial indication earlier this year. Now, the drugmaker is giving up hope in Europe as well.

Incyte has withdrawn its EU application for PD-1 drug Zynyz, or retifanlimab, after saying it couldn’t adequately address the CHMP’s questions over survival data underpinning its market hopes in squamous cell carcinoma of the anal cavity, the EMA revealed.

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.