As talk of drug pric­ing takes cen­ter stage, Am­gen slash­es Repatha price by near­ly 60%

Biotech ma­jor Am­gen $AMGN has de­cid­ed to cut its loss­es, and the price, of its cho­les­terol drug Repatha in a scram­ble to claw back its com­pet­i­tive po­si­tion­ing ver­sus Re­gen­eron $REGN and Sanofi $SNY, the team be­hind its main ri­val treat­ment, Pralu­ent.

Fol­low­ing ap­provals in 2015 the two drugs were pegged to at­tain block­buster sta­tus for their abil­i­ty to dra­mat­i­cal­ly low­er lev­els of LDL cho­les­terol, but in­stead faced push­back from in­sur­ers for their high stick­er prices that led to low­er adop­tion than ex­pect­ed, de­spite lat­er tri­als that demon­strat­ed the PC­SK9 in­hibitors al­so sig­nif­i­cant­ly cut the risk of heart at­tacks and stroke.

On Wednes­day, Am­gen said it was low­er­ing Repatha’s list price by 60% to $5,850 from $14,100 per year in a bid to low­er co­pays, par­tic­u­lar­ly for pa­tients cov­ered by Medicare. An es­ti­mat­ed 75% of Medicare pa­tients pre­scribed a PC­SK9 in­hibitor nev­er ac­tu­al­ly fill their pre­scrip­tions, main­ly due to high out-of-pock­et costs, not­ed Am­gen CEO Robert Brad­way.  

Am­gen’s move fol­lows Re­gen­eron and Sanofi’s de­ci­sion to low­er the price of its Pralu­ent to a range of $4,500 – $8,000 from the orig­i­nal $14,600 per year.  This change did not mod­i­fy Pralu­ent’s list price, but rather was of­fered in the form of a larg­er re­bate to gi­ant phar­ma­cy ben­e­fit man­ag­er Ex­press Scripts $ES­RX, who re­ward­ed the ac­tion by po­si­tion­ing Pralu­ent as the pre­ferred PC­SK9 in­hibitor in their for­mu­la­ry. Un­like Repatha, Pralu­ent has al­so shown to low­er the risk of death.   

Last year, Repatha brought in $319 mil­lion, while Pralu­ent gen­er­at­ed $195 mil­lion.

Bri­an Sko­r­ney

Am­gen’s an­nounce­ment could “re­sult in some mar­ket seg­men­ta­tion, where Am­gen claims greater share of the Medicare mar­ket but Sanofi/Re­gen­eron dom­i­nates the pri­vate in­sur­ance mar­ket” not­ed Baird an­a­lyst Bri­an Sko­r­ney in a note. Ac­cord­ing to Jef­feries’ an­a­lyst Michael Yee, the cur­rent PC­SK9 mar­ket is half Medicare and half com­mer­cial, while 75% of Medicare scripts are ap­proved and have in­sur­ance ver­sus on­ly 40% for com­mer­cial pay­ors. But, 75% of Medicare-ap­proved pre­scrip­tions do not get filled and are even­tu­al­ly aban­doned due to an av­er­age $280-370/month co-pay, he said. “This is mon­ey lit­er­al­ly left on the ta­ble.”

Yee made some quick back-of-the-en­ve­lope cal­cu­la­tions:

If we tried to es­ti­mate and gross up cur­rent “lost rev­enue” now that be­come “booked rev­enue” over next year…we es­ti­mate the con­tri­bu­tion to­day could be up to a 25% boost – i.e. they do $200 mil­lion/year in medicare busi­ness but 75% is lost due to co-pay af­ford­abil­i­ty. If the co-pay drops to the new $25-150 then the $200 mil­lion in medicare grossed up could be $150 mil­lion+ tech­ni­cal­ly per year…ob­vi­ous­ly this is a longer term thing to say that half the busi­ness now should open up and get more ac­ces­si­bil­i­ty.

As po­lit­i­cal and pub­lic scruti­ny in­to drug pric­ing in­ten­si­fies, a host of Amer­i­can drug­mak­ers have made pledges to quell their ap­petite for drug price hikes. Am­gen in May al­so pledged not to take price in­creas­es planned for Ju­ly, and promised it would not do so for the rest of 2018.

Im­age: Am­gen CEO Robert Brad­way (cen­ter) at the White House short­ly af­ter Pres­i­dent Trump took of­fice in 2017 Get­ty

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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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.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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