Am­gen and No­var­tis ID the fin­ish line in a wicked scram­ble for first CGRP mi­graine drug OK

Am­gen and its part­ners at No­var­tis are one step clos­er to field­ing a new mi­graine drug in the US. The phar­ma gi­ants said Thurs­day af­ter­noon that the FDA has ac­cept­ed their ap­pli­ca­tion for erenum­ab, the fur­thest ad­vanced CGRP ther­a­py which is now nav­i­gat­ing to­ward a May 17 PDU­FA date.

The com­pa­nies have now dubbed the drug Aimovig, with piv­otal da­ta from 2,600 pa­tients.

This is like­ly go­ing to be quite a crowd­ed field, though, with a line­up of de­vel­op­ers po­si­tion­ing their own late-stage prod­ucts for the last leg of the race through the agency. And the da­ta so far in­di­cate that sev­er­al of these new drugs will look a lot alike.

Sean Harp­er

Te­va re­cent­ly lined up a 1.5-day ad­van­tage for fre­manezum­ab, re­duc­ing mi­graine days by a sig­nif­i­cant mar­gin over place­bo and putting it in a mix of re­sults post­ed that tends to hov­er around the 2-day mark. And it has re­sults for month­ly and quar­ter­ly dos­ing. Re­searchers are al­ways quick to protest any tri­al com­par­isons that aren’t head-to-head, and pa­tient pop­u­la­tions and dos­ing aren’t an even match in the stud­ies. But pay­ers will al­so be ex­pect­ed to con­sid­er Eli Lil­ly’s 2-day ad­van­tage, or a Phase III out­come for Am­gen and No­var­tis that was quite sim­i­lar to Alder’s for 70 mg erenum­ab, the ther­a­py that is the fur­thest out front. Al­ler­gan al­so has high hopes for its oral ther­a­py in-li­censed from Mer­ck for $250 mil­lion up­front.

Am­gen R&D chief Sean Harp­er has been frank about how their drug lines up with the com­pe­ti­tion, with­out much to sep­a­rate the lead­ers. That makes first mover ad­van­tage all the more im­por­tant. De­ci­sion Re­sources has es­ti­mat­ed that the CGRP mar­ket by it­self could swell to $4.5 bil­lion, mak­ing this a block­buster area of con­tention — un­less the sales num­bers are overblown.

It’s clear that the two ma­jor league play­ers — which re­worked their glob­al al­liance last April to split the key US sales are­na — are al­ready think­ing of how they’ll po­si­tion this drug once it hits the mar­ket, pro­vid­ed the FDA fol­lows through with an OK.

“Mi­graine is a se­ri­ous neu­ro­log­i­cal dis­ease that has a sub­stan­tial eco­nom­ic bur­den for both pa­tients and the health­care sys­tem, yet it con­tin­ues to be un­der rec­og­nized and un­der treat­ed,” said Harp­er.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.

Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.