Look­ing to get ahead in a packed mi­graine mar­ket, Am­gen touts head-to-head da­ta for Aimovig

A year af­ter Am­gen an­nounced its in­jectable mi­graine pre­ven­tion drug Aimovig proved a bet­ter op­tion than the wide­ly used treat­ment top­i­ra­mate in a head-to-head study, the phar­ma com­pa­ny is rolling out the full da­ta. But will it be enough to com­pete in a packed mar­ket, in­clud­ing new oral op­tions?

In a Phase IV study con­duct­ed by Am­gen’s old part­ner No­var­tis, mi­graine pa­tients in the Aimovig arm showed a sig­nif­i­cant­ly low­er dis­con­tin­u­a­tion rate due to side ef­fects: 10.5% ver­sus 38.9% in the top­i­ra­mate arm (p<0.001), ac­cord­ing to the com­pa­nies. In ad­di­tion, 55.4% of pa­tients in the Aimovig arm achieved at least a 50% re­duc­tion from base­line in their month­ly mi­graine days, com­pared to 31.2% in the top­i­ra­mate group (p<0.001).

The most com­mon side ef­fects in the Aimovig group were fa­tigue, nau­sea, dis­tur­bance in at­ten­tion and dizzi­ness. The top­i­ra­mate group saw sim­i­lar side ef­fects, in ad­di­tion to paraes­the­sia, or a “pins-and-nee­dles” sen­sa­tion.

Rob Lenz

“HER-MES is the first study that di­rect­ly com­pared the ther­a­peu­tic ef­fects of an an­ti­body and a small mol­e­cule in mi­graine pre­ven­tion,” tri­al in­ves­ti­ga­tor Uwe Reuter said in a state­ment. “The pos­i­tive out­comes strength­en the ef­fi­ca­cy and safe­ty pro­file of erenum­ab as a mi­graine pre­ven­tion treat­ment for pa­tients with mi­graine.”

Aimovig was ap­proved in 2018 for mi­graine pre­ven­tion in adults. It tar­gets cal­ci­tonin gene-re­lat­ed pep­tides (CGRP), which trans­mit pain sig­nals to the brain and are thought to have a hand in gen­er­at­ing and main­tain­ing mi­graine-as­so­ci­at­ed headaches.

While Am­gen and No­var­tis were ini­tial­ly co-com­mer­cial­iz­ing the drug in the US, the Swiss phar­ma bowed out of the part­ner­ship this sum­mer, lay­ing off 186 em­ploy­ees in the process. No­var­tis con­tin­ues to col­lect roy­al­ties and pay Am­gen for a por­tion of com­mer­cial­iza­tion costs.

The move came as Aimovig, which was ex­pect­ed to quick­ly rake in over $1 bil­lion per year, con­tin­ued to miss ex­pec­ta­tions. Last year it made $378 mil­lion in the US, which is a mod­est jump from $306 mil­lion in 2019, but still short of block­buster pre­dic­tions.

That’s like­ly due in part to a slew of ri­vals that have en­tered the space since Aimovig was ap­proved, in­clud­ing near­ly iden­ti­cal treat­ments from Eli Lil­ly, Al­ler­gan and Te­va. And while Am­gen touts Aimovig as the first CGRP drug to win ap­proval in mi­graine pre­ven­tion, new oral prod­ucts from Bio­haven and Ab­b­Vie pose stiff com­pe­ti­tion to those old in­jecta­bles.

Ab­b­Vie en­tered the com­mer­cial bat­tle for mi­graine pre­ven­tion back in Sep­tem­ber, when it land­ed an OK for its oral CGRP re­cep­tor ag­o­nist Qulip­ta. The drug came from Ab­b­Vie’s $63 bil­lion buy­out of Al­ler­gan, and makes the third ap­proved drug in Ab­b­Vie’s mi­graine port­fo­lio.

While Ab­b­Vie’s oth­er CGRP drug Ubrelvy was al­ready ap­proved for the acute treat­ment of mi­graine, Bio­haven pulled ahead in May when it scored an ex­pand­ed la­bel for Nurtec to cov­er pre­ven­ta­tive use.

“Am­gen is ded­i­cat­ed to help­ing the mil­lions of peo­ple who live with this de­bil­i­tat­ing neu­ro­log­i­cal dis­ease get back to what’s im­por­tant to them while liv­ing with more mi­graine-free days,” said Rob Lenz, se­nior VP of glob­al de­vel­op­ment at Am­gen.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

GSK 'Target the Future' Ad Campaign

Glax­o­SmithK­line's friend­ly ‘shark tank’ crowd­sources ideas for mul­ti­ple myelo­ma, kicks off big­ger push

GlaxoSmithKline is inviting everyone to its friendly shark tank. Its “Think Tank” challenge launching today aims to gather the best pitches for ideas in multiple myeloma with a final pitch-off “Shark Tank” TV show-style finish next year.

The innovation contest kicks off GSK’s bigger “Target the Future” unbranded campaign to advance innovation and awareness in multiple myeloma.

“We have a good sense of where the unmet need lies and what tools may be welcomed by this community, and we’ll continue to do that as part of this program, but the ‘Think Tank’ kickoff is to bring new ideas to the table — things that come from a more grassroots perspective than a large pharma perspective,” Christine Roth, senior VP and global head of oncology at GSK, said.

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Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.