Eli Lil­ly touts some mixed PhI­II re­sults for clus­ter headaches as Am­gen, No­var­tis prep a mar­ket-bust­ing move in mi­graine

With Am­gen and No­var­tis ea­ger­ly await­ing their PDU­FA date for the lead­ing CGRP mi­graine drug Aimovig lat­er this week, Eli Lil­ly is step­ping up with some mixed Phase III re­sults for its own con­tender in the field.

Christi Shaw

In a hit and a miss, Lil­ly re­searchers say that gal­canezum­ab scored on the pri­ma­ry end­point in a Phase III study of pa­tients suf­fer­ing from episod­ic, week­ly clus­ter headaches. Placed up against a place­bo, their drug achieved a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in clus­ter at­tacks — though the p val­ue of 0.036 was a long way from a stand­out grade. 

Lil­ly al­so not­ed that an­oth­er Phase III for chron­ic clus­ter headaches failed — though you can be sure the phar­ma gi­ant was far more ea­ger to high­light the pos­i­tive re­sults in its re­lease. And now Lil­ly ex­ecs are set­ting up talks with reg­u­la­tors about the way for­ward to the mar­ket.

Lil­ly has al­ready post­ed its pos­i­tive late-stage da­ta for this drug in suc­cess­ful­ly re­duc­ing mi­graines. CGRP drugs are wide­ly viewed as the up­com­ing stan­dard of care for this cat­e­go­ry of dis­ease, and Am­gen and No­var­tis aim to push hard to cap­i­tal­ize on their fron­trun­ner sta­tus — pro­vid­ed the FDA comes through as ex­pect­ed with an ap­proval with­in a cou­ple of days.

An­a­lysts have of­fered a $1.2 bil­lion peak sales es­ti­mate for Aimovig — mak­ing it a top-12 drug for this year — which il­lus­trates just how im­por­tant a ground­break­ing po­si­tion can be in drug de­vel­op­ment.

Lil­ly is in a fa­mil­iar po­si­tion fur­ther back in the field, as it awaits an FDA de­ci­sion some­time in the third quar­ter. But they should be next in line be­hind the Am­gen/No­var­tis team. Te­va’s ri­val fre­manezum­ab had been in line for a June de­ci­sion, then ear­li­er this month con­ced­ed that man­u­fac­tur­ing prob­lems would tem­porar­i­ly de­rail its pro­gram and push any ap­proval and mar­ket­ing launch fur­ther back in the year. And in March lit­tle Alder, which al­so has a con­tender in the mix, oust­ed its CEO and be­gan to re­struc­ture af­ter falling be­hind the lead­ers.

Eli Lil­ly has been scram­bling to beef up its on­col­o­gy pipeline with bolt-on deals this year. The phar­ma gi­ant has gained a num­ber of new ap­provals in re­cent years, but was se­ri­ous­ly de­layed on baric­i­tinib last year, be­fore the FDA abrupt­ly de­cid­ed to al­low their mar­ket­ing pitch to move through a re­view with­out a re­quired safe­ty tri­al.

“Clus­ter headache can be dif­fi­cult to eval­u­ate in clin­i­cal stud­ies, which has con­tributed to few avail­able treat­ment op­tions for clus­ter headache, of­ten con­sid­ered the most se­vere pain one can ex­pe­ri­ence,” said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines. “The pos­i­tive re­sults in episod­ic clus­ter headache are tru­ly a land­mark mo­ment—both for peo­ple liv­ing with clus­ter headache and for our re­searchers at Lil­ly, many of whom have spent more than two decades re­search­ing and de­vel­op­ing in­no­v­a­tive, non-opi­oid treat­ment op­tions for dis­eases like mi­graine and clus­ter headache.”

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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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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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.

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.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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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.

FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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