Am­gen, No­var­tis ready to roll as FDA green lights block­buster cam­paign for mi­graine drug — priced at $6,900

Am­gen and No­var­tis have brought home the big Aimovig (erenum­ab) ap­proval they’ve been hunt­ing, scor­ing first-mover ad­van­tage for a block­buster con­tender that will now look to start chang­ing the stan­dard of care for de­bil­i­tat­ing mi­graines.

An­tho­ny Hoop­er

Sig­nif­i­cant­ly, the heavy­weight part­ners — who will share the US mar­ket­ing rights — are launch­ing this CGRP pi­o­neer with a list price of $6,900 a year. That num­ber comes in well be­low the $8,000 to $10,000 spread that Ex­press Scripts had al­ready warned would be un­ac­cept­able to them. It’s al­so well un­der the $8,500 fig­ure the In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view pen­cilled in for their re­view, which they con­sid­ered too cost­ly for all but the most se­ri­ous­ly af­flict­ed.

That mes­sage clear­ly got through to the man­u­fac­tur­ers. Am­gen in par­tic­u­lar has had to work out some deals on its PC­SK9 drug to get that past steep pay­er hur­dles.

They’ll be sell­ing their drug at $575 list for once month­ly 70 or 140 mg sin­gle-use in­jec­tors. And some­thing to keep in mind: Dis­ease ad­vo­cates say that mi­graines aren’t un­com­mon, cost­ing the econ­o­my tens of bil­lions of dol­lars a year for the dev­as­tat­ing at­tacks.

Steve Miller, chief med­ical of­fi­cer of Ex­press Scripts, had raised a warn­ing flag on this drug, try­ing to steer the com­pa­nies away from a high whole­sale price, which would be used to set out-of-pock­et costs for con­sumers and a high-wa­ter mark for pay­ers to dis­count against.

“If your ex­pec­ta­tion is that you are not go­ing to ac­tu­al­ly get that high list price, then don’t do that to pa­tients who have high co-pays,” Miller told Reuters. “Let’s be more bal­anced. Let’s get back to where gross-to-net is not so dif­fer­ent.”

Ex­press Scripts gave the drug price a quick thumbs up this morn­ing, but that doesn’t mean that they’ll make the drug read­i­ly avail­able to every­one who asks for it. A spokesper­son tells me:

Steve Miller

“We be­lieve they are pric­ing the drug re­spon­si­bly at the low­er end of the val­ue-based price range. We be­lieve there is a se­ri­ous un­met need for pa­tients with mi­graine. How­ev­er, not all pa­tients will need this ther­a­py. We see it for peo­ple with mi­graine who have failed pre­ven­tive ther­a­py. We will en­sure ap­pro­pri­ate pa­tients have ac­cess to this med­i­cine and will put a pri­or au­tho­riza­tion pro­gram in place to help pay­ers get the most val­ue for the mon­ey they spend.”

In a sign of the times, Am­gen and No­var­tis mar­ket­ing teams are wast­ing no time set­ting up an ag­gres­sive cam­paign to fo­cus more at­ten­tion on mi­graine as they roll out a ma­jor mar­ket­ing ef­fort. And they’ve got a pa­tient sup­port group — Aimovig Al­ly — ready to roll.

Time is a cru­cial fac­tor here. Eli Lil­ly is lined up as the sec­ond en­try to the CGRP space in a mat­ter of months, with fa­mil­iar da­ta on its abil­i­ty to sig­nif­i­cant­ly cut the num­ber of mi­graines chron­ic suf­fer­ers have to en­dure. Then there’s Te­va, which has to en­dure a dam­ag­ing de­lay for its ther­a­py. And lit­tle Alder is wait­ing in the wings as Al­ler­gan press­es ahead with an oral drug they’d like to use to leapfrog every­one.

To­day, though, be­longs to Am­gen and No­var­tis, which ex­e­cut­ed well on a huge Phase III ef­fort. 

“In ad­di­tion to bring­ing a new ther­a­peu­tic op­tion to pa­tients in the U.S., Am­gen al­so has a com­mit­ment to re­shape the pub­lic’s per­cep­tion of this stig­ma­tized dis­ease,” said An­tho­ny Hoop­er, ex­ec­u­tive vice pres­i­dent of glob­al com­mer­cial op­er­a­tions at Am­gen. “We have pledged a mis­sion to help change mis­con­cep­tions, stereo­typ­ing and even judg­ment that peo­ple with mi­graine face on a dai­ly ba­sis. Through ed­u­ca­tion­al pro­grams and ini­tia­tives, we hope to pro­mote more mean­ing­ful con­nec­tiv­i­ty and di­a­logue among pa­tients, physi­cians, em­ploy­ers and pay­ers.” 

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.