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.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.