Watch out Am­gen and Te­va, Eli Lil­ly got its green light for a ri­val CGRP mi­graine drug — and they’re com­ing af­ter you

Eli Lil­ly has just scored the third FDA OK for a CGRP mi­graine drug, and now the phar­ma gi­ant is set­ting out to leapfrog the pi­o­neers who made it to mar­ket first.

The agency came through with the for­mal ap­proval of Em­gal­i­ty (gal­canezum­ab) on Thurs­day night, set­ting the stage for an am­bi­tious and ag­gres­sive mar­ket­ing en­gine to get revved up for a tire-burn­ing late start.

Wei-Li Shao

“We cer­tain­ly don’t think it’s a me-too sit­u­a­tion,” says Wei-Li Shao, vice pres­i­dent of the neu­ro­science busi­ness at Eli Lil­ly. 

Ob­jec­tive­ly, even some of the top play­ers in this group — such as ex-Am­gen R&D chief Sean Harp­er — rec­og­nize that the da­ta on these new CGRP drugs bear a lot of sim­i­lar­i­ties. Am­gen set the price lev­el with its $575 per month rate, which Te­va fell in line with. And now Eli Lil­ly is fol­low­ing that move down to the pen­ny.

So there’s a lot of com­pet­i­tive me-too think­ing that’s go­ing on here. But Eli Lil­ly is shoot­ing for best-in-class sta­tus by stak­ing claims to three key mes­sages:

  1. Da­ta. One in sev­en of their pa­tients achieved “mi­graine free­dom,” which is some­thing you can ex­pect to hear a lot about as the pro­mo­tion­al work be­gins. There’s no guar­an­tee, says Shao, but the pos­si­bil­i­ty of free­dom from fur­ther mi­graines could be a com­pelling lure.
    True, “most (pa­tients) get about a 50% re­duc­tion,” he says, “but this shot at mi­graine free­dom is an im­por­tant dif­fer­en­tia­tor.”
  2. Ac­cess. Lil­ly is ready to roll with a promise that con­sumers will get a chance to start tak­ing their drug with no out-of-pock­et con­tri­bu­tions to be con­cerned about.
  3. Ease of use. Lil­ly, no stranger to ad­dress­ing ma­jor mar­ket dis­eases where pa­tients have to get ac­tive­ly in­volved in dos­ing, is launch­ing with an au­to in­jec­tor that most peo­ple who use the drug should be able to swing, no prob­lem.
Er­ic Pearl­man

This is a mar­ket they as­sess as 30 mil­lion pa­tients strong, where on­ly 10% of pa­tients are be­ing treat­ed, says Er­ic Pearl­man, se­nior med­ical fel­low at Eli Lil­ly. So they know the mar­ket is big enough to carve out some big pa­tient pop­u­la­tions. An­a­lysts wouldn’t dis­agree. Some of the top ob­servers in the field be­lieve these com­pa­nies will divvy up a mar­ket with $5 bil­lion to $6 bil­lion in sales po­ten­tial by the mid-’20s as the full field of drugs are out there. Alder will like­ly be the 4th play­er, but can’t ar­rive be­fore next year.

Lil­ly has a no­table pres­ence in di­a­betes as well as on­col­o­gy, but it sees a big fu­ture for it­self in pain. 

Las­mid­i­tan has made some im­pres­sive marks in late phase de­vel­op­ment, promis­ing to add to its pres­ence in the pain field. And then there’s tanezum­ab for chron­ic pain, where there’s al­so some big ex­pec­ta­tions for fu­ture rev­enue growth.

For Lil­ly, its mi­graine drug of­fers a chance for the mar­ket­ing team to make up for time lost to an R&D group known for a steady — if not slow — ap­proach to de­vel­op­ment work.

Just be­cause they’re start­ing in third place doesn’t mean they can’t be the leader in short or­der. Now they get to prove it.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.