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.” 

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.