Bio­haven touts a pair of PhI­II wins for mi­graine pill, but shares ric­o­chet off of weak da­ta

Bio­haven has re­leased a set of pos­i­tive Phase III da­ta for their fast-act­ing mi­graine drug, which close­ly par­al­lel a ri­val at Al­ler­gan and trail well be­hind Eli Lil­ly’s las­mid­i­tan. And the biotech will now join the scram­ble un­der­way for an ap­proval in a field that’s about to be se­vere­ly dis­rupt­ed.

In­vestors didn’t like the num­bers ear­ly Mon­day morn­ing, send­ing shares $BHVN down 40%. That clear­ly wasn’t the way Bio­haven was bet­ting. The biotech paid Bris­tol-My­ers Squibb $50 mil­lion just a cou­ple of weeks ago to re­struc­ture their li­cens­ing deal, cut­ting the roy­al­ty stream to the sin­gle dig­its. But in the hours up to the close, the stock — backed by some heavy­weight mar­ket play­ers — went on a roller coast­er ride in the red, end­ing the day down 7%.

Al­ler­gan — which will have an­oth­er Phase III tri­al to re­port on — saw its shares rise a bit, while Lil­ly stock jumped close to 2%.

The co-pri­ma­ry end­points for Bio­haven’s oral rimegepant (BHV-3000) was pain free­dom and free­dom from most both­er­some symp­tom 2 hours af­ter tak­ing the pill in two piv­otal stud­ies.

Their pain free­dom rate was 19.2% and 19.6% for the drug, ver­sus 14.2% and 12% for the place­bo arm. Free­dom from MBS was 37.6% and 36.6% ver­sus 25.2% and 27.7% in the sug­ar pill group.

That ev­i­dent­ly may have been sta­tis­ti­cal­ly sig­nif­i­cant, but it wasn’t a big enough spread to con­vince skep­tics won­der­ing about the drug’s clin­i­cal sig­nif­i­cance in a com­pet­i­tive field.

Com­pare rimegepant to Al­ler­gan’s oral CGRP ubro­gepant, where the first Phase III re­port­ed out free­dom for pain at 2 hours for 19.2% and 21.2% for two dif­fer­ent dos­es and 11.8% in the place­bo arm; 38.6% and 37.7% on MBS and 27.8% in the place­bo arm.

Eli Lil­ly’s las­mid­i­tan — which works by hit­ting 5-HT1F re­cep­tors — did even bet­ter, de­spite be­ing dogged by high place­bo rates. Lil­ly $LLY, which paid $960 mil­lion to buy CoLu­cid and las­mid­i­tan, al­so has a CGRP drug that has per­formed in line with the rest of the in­jecta­bles.

Two hours af­ter tak­ing las­mid­i­tan or a place­bo, here were the the lat­est Phase III re­spons­es on free­dom from pain by dosage: 28.6% for 50 mg (p=0.003); 31.4% for 100 mg (p<0.001); 38.8% for 200 mg (p<0.001) and 21.3% for place­bo. In­ves­ti­ga­tors al­so nailed an end­point on free­ing pa­tients of their most both­er­some symp­tom, whether that was nau­sea, sen­si­tiv­i­ty to sound or sen­si­tiv­i­ty to light. The da­ta: 40% for 50 mg (p=0.009); 44.2% for 100 mg (p<0.001); 48.7% for 200 mg (p<0.001) and 33.5% for place­bo.

Back-to-back Phase II­Is, how­ev­er, won’t trans­late in­to a quick FDA fil­ing. Bio­haven not­ed in a re­lease that it won’t be ready to file un­til 2019, keep­ing up with Al­ler­gan on that score.

Vlad Coric

The ri­vals here are bet­ting that they can take mar­ket share for treat­ing mi­graines as heavy­weights com­pete over in­jectable CGRP drugs head­ed to reg­u­la­tors for the pre­ven­tion of acute mi­graine. Am­gen and No­var­tis lead the way on that front, with a drug un­der re­view. Te­va, and Alder are an­gling for a fol­lowup po­si­tion.

The one com­mon char­ac­ter­is­tic of these drugs is that they all per­form in re­mark­ably sim­i­lar ways, leav­ing oral de­liv­ery and price as two fea­tures that these two new ther­a­pies can com­pete on. Al­ler­gan has al­so had to ex­plain some cas­es of liv­er tox in its first Phase III — a con­cern for the class — while Bio­haven says it saw noth­ing to alarm in­ves­ti­ga­tors in its Phase III stud­ies.

Bio­haven CEO Vlad Coric had this to say:

By com­bin­ing pos­i­tive ef­fi­ca­cy re­sults and a fa­vor­able safe­ty pro­file with ease of oral dos­ing, we be­lieve that rimegepant will rep­re­sent a sig­nif­i­cant im­prove­ment over ex­ist­ing treat­ment op­tions.

Bio­haven shares al­so took a beat­ing last fall when their Phase II/III study of tri­grilu­zole demon­strat­ed not on­ly that it didn’t work bet­ter than a place­bo in treat­ing spin­ocere­bel­lar atax­ia, but pa­tients in the study al­so re­port­ed in larg­er num­bers that the place­bo helped them more than the drug.

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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