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.”

Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.