Am­gen, No­var­tis cel­e­brate promis­ing mi­graine da­ta, but Te­va and Alder are prepar­ing to crash the par­ty

Am­gen $AMGN post­ed some im­pres­sive re­sults for its Phase II study of a close­ly-watched mi­graine drug, but the big biotech may still be forced to ac­cept a shrink­ing share of what is shap­ing up as a high­ly com­pet­i­tive mar­ket as ri­vals crowd the same sec­tor.

Ge­of­frey Porges, Leerink

The key da­ta on erenum­ab: 40 per­cent and 41 per­cent of the pa­tients in the two dose arms (70 mg and 140 mg dos­es) ex­pe­ri­enced a re­duc­tion of 50% or more in the num­ber of mi­graine days record­ed at week 12, com­pared to about one in 4 (24%) of those tak­ing a place­bo.

In ad­di­tion, Am­gen’s in­ves­ti­ga­tors say the safe­ty pro­file for their drug looked quite sim­i­lar to a place­bo.

If those num­bers hold up in the soon-to-be-com­plet­ed Phase III, Am­gen and its part­ners at No­var­tis $NVS — which holds ex-US rights — should be look­ing at an ap­proval.

This drug tar­gets the cal­ci­tonin-gene-re­lat­ed-pep­tide (CGRP) re­cep­tor. And there­in lies the rub for Am­gen and No­var­tis. The gi­ants have a drug that does some­thing sim­i­lar to what a pair of ri­vals from Alder $AL­DR and Te­va $TE­VA does. And they may well have to wind up split­ting the mar­ket among drugs that look re­mark­ably sim­i­lar.

Leerink’s Ge­of­frey Porges took a look at the da­ta and fig­ures that Am­gen can still flirt with block­buster suc­cess with what it has, even though the drugs from Alder and Te­va bind di­rect­ly to the lig­and while Am­gen/No­var­tis’ drug tar­gets the re­cep­tor. But he’s cut­ting his peak rev­enue fore­cast.

Am­gen, notes Porges:

(F)ailed to dif­fer­en­ti­ate erenum­ab from com­pet­ing pro­grams from Alder (AL­DR, [OP]) and Te­va (TE­VA, [OP]) – al­though the re­sults con­tin­ue to val­i­date the class of CGRP tar­gets for the treat­ment of mi­graines. Cur­rent­ly we an­tic­i­pate first rev­enues for erenum­ab in 2018 to­tal­ing $85mm, in­creas­ing to $991mm by 2023, re­flect­ing a prob­a­bil­i­ty of suc­cess weight­ed ad­just­ment of 65%, and an ini­tial mar­ket share of 50% de­clin­ing to 23% as com­pet­ing prod­ucts en­ter the mar­ket. Our fore­cast is be­low re­cent con­sen­sus, which pre­dicts 2018 rev­enues of $161mm ex­pand­ing to $1.3bn in 2023. We are main­tain­ing our fore­cast while await­ing greater dis­clo­sures from Am­gen, in­clud­ing da­ta from the more clin­i­cal­ly mean­ing­ful end­points of 75% and 100% re­duc­tion in mi­graine days and the phase 3 erenum­ab tri­al re­sults for both episod­ic and chron­ic mi­graine.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.