Ab­b­Vie preps a chal­lenge to a ri­val mi­graine drug from Bio­haven, spelling out an up­beat set of PhI­II da­ta

Phase III ad­vance tri­al da­ta for Ab­b­Vie’s mi­graine pre­ven­tion drug ato­gepant look good — but are the re­sults good enough to ri­val Bio­haven’s two-in-one treat­ment and pre­ven­tion drug, rimegepant, sold as Nurtec?

Ab­b­Vie picked up ato­gepant from Al­ler­gan in a $63 bil­lion buy­out last year. It al­so claimed the Botox fran­chise and $16 bil­lion in an­nu­al rev­enue.

Vamil Di­van, an eq­ui­ty re­search an­a­lyst with Mizuho Fi­nan­cial Group, said ato­gepant and rimegepant are “nat­ur­al com­peti­tors”: two oral drugs that could hit the mar­ket around the same time. Nurtec took the lead with FDA ap­proval in Feb­ru­ary. Ato­gepant met pri­ma­ry and sec­ondary end­points in piv­otal Phase III test­ing, and Illi­nois-based Ab­b­Vie is push­ing for reg­u­la­to­ry sub­mis­sions in the US and abroad.

“We do think the Nurtec prod­uct will be big­ger over­all, but a lot of that is be­cause the rev­enue is com­ing from the treat­ment side, not just from pre­ven­tion,” Di­van said.

Ab­b­Vie has a sep­a­rate FDA-ap­proved drug, ubro­gepant, to treat adults who ex­pe­ri­ence mi­graines with­out au­ra.

“The main thing that Ab­b­Vie seems to have is the drug looks a lot more ef­fec­tive than Nurtec does,” Di­van said.

Though he fol­lowed up with a dis­claimer that “these com­par­isons are al­ways chal­leng­ing to do when you’re com­par­ing across tri­als.” And ato­gepant may come with high­er rates of in­creased con­sti­pa­tion and nau­sea, ac­cord­ing to Mizuho’s analy­sis.

The in­dus­try has come a long way since the first drugs spe­cif­ic to mi­graine pre­ven­tion — erenum­ab, fre­manezum­ab and gal­canezum­ab — were ap­proved by the FDA in 2018. Gal­canezum­ab (or Em­gal­i­ty), for ex­am­ple, re­quires pa­tients to self-in­ject one dose per month. But in­jectable drugs may soon be nee­dled out by oral can­di­dates like ato­gepant and rimegepant. Both Ab­b­Vie and Bio­haven tout their oral drugs as first of a kind.

With mi­graine af­fect­ing near­ly one in four US house­holds, the ill­ness is the third most preva­lent world­wide, ac­cord­ing to the Mi­graine Re­search Foun­da­tion. Mi­graine-in­duced health­care and lost pro­duc­tiv­i­ty costs could be as high as $36 bil­lion an­nu­al­ly in the US.

In its Phase III tri­al, Ab­b­Vie test­ed 910 pa­tients who suf­fer four to 14 mi­graine days per month with its oral­ly ad­min­is­tered cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) re­cep­tor an­tag­o­nist. The pa­tients re­ceived ei­ther 10 mg, 30 mg, or 60 mg of ato­gepant once per day, or a place­bo.

Re­sults showed that those who took vary­ing amounts of ato­gepant over the course of 12 weeks ex­pe­ri­enced be­tween 3.69 and 4.2 few­er mi­graine days com­pared to the ini­tial month­ly mean. Those on the place­bo said they had 2.48 few­er mi­graine days. To put that in per­spec­tive, just over half of pa­tients on ato­gepant ex­pe­ri­enced at least a 50% re­duc­tion in mean month­ly mi­graine days, com­pared to 29% of place­bo pa­tients.

Pa­tients who re­ceived 30 or 60 mg of atope­gant al­so passed all of Ab­b­Vie’s sec­ondary end­points, in­clud­ing change from the base­line in mean headache days, mean month­ly days in which acute med­ica­tion was used, mean per­for­mance of dai­ly ac­tiv­i­ties and phys­i­cal im­pair­ment do­main scores, and Mi­graine-Spe­cif­ic Qual­i­ty of Life Ques­tion­naire (MSQ) Role Func­tion-Re­stric­tive do­main scores. Those who on­ly took 10 mg passed just four of the six sec­ondary end­points.

Tom Hud­son

“Mi­graine at­tacks can be de­bil­i­tat­ing, but mi­graine is a treat­able dis­ease, and peo­ple liv­ing with it are not alone in their bat­tle to con­trol it,” Tom Hud­son, SVP of R&D and CSO at Ab­b­Vie, said in a state­ment. “With the re­sults from these tri­als, we aim to pro­vide a safe and ef­fec­tive pre­ven­tive treat­ment that of­fers pa­tients and health­care providers a sim­ple, once dai­ly oral treat­ment that works specif­i­cal­ly by block­ing CGRP re­cep­tors and pre­vent­ing mi­graine.”

Roger Perl­mut­ter’s new gig, Covid-19 IP dra­ma, Vivek Ra­maswamy's coach on the SPAC train, and more

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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As­traZeneca, Dai­ichi Sankyo un­cork new TNBC da­ta for 2nd part­nered ADC — and it's adding more heat un­der Gilead­'s Trodelvy

After the approval of their partnered anti-HER2 antibody-drug conjugate earlier this year, AstraZeneca and Daiichi Sankyo are riding high on the promise of their blooming partnership. Now a second ADC is showing promise in hard-to-treat breast cancer, and the companies have their eyes set on their only approved competitor in the space.

AstraZeneca and Daiichi Sankyo’s next-gen ADC datopotamab deruxtecan posted a 43% response rate and five confirmed complete or partial responses among 21 patients with triple-negative breast cancer, according to cohort data from the TROPION-PanTumor01 Phase I study presented Saturday at the virtual ESMO Breast annual meeting.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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