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.”

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,800+ biopharma pros reading Endpoints daily — and it's free.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,800+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,800+ biopharma pros reading Endpoints daily — and it's free.

Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,800+ biopharma pros reading Endpoints daily — and it's free.

Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.