Sanofi/Re­gen­eron’s one-two punch on PC­SK9 price and health da­ta wins a key con­vert as Ex­press Scripts cre­ates ex­clu­sive for­mu­la­ry deal

Just 7 weeks af­ter Sanofi $SNY and Re­gen­eron $REGN flagged piv­otal da­ta on a clear mor­tal­i­ty ben­e­fit to be had from its PC­SK9 car­dio drug Pralu­ent, they’re back with a chum­my pub­lic self­ie with Ex­press Scripts that swaps a new dis­count price in ex­change for a pledge to dis­man­tle any hur­dles that could pre­vent the PBM’s 20 mil­lion mem­bers from tak­ing ad­van­tage of it.

Len Schleifer

No­body’s talk­ing specifics here, but in March Sanofi/Re­gen­eron pledged to cut its price to $4,460 to $7,975 a year for pay­ers who are will­ing to stop throw­ing up road­blocks to this drug, drop­ping to a price that on the low end is not much high­er than the $10-a-day cost of the old gen­er­a­tion of statins be­fore they went gener­ic. At the high end, it still marks a sharp drop from the $14,000 whole­sale price that had been the mar­ket stan­dard used to peg dis­counts against.

Salt­ing that deal with new mor­tal­i­ty ben­e­fits from longterm use, a goal that elud­ed ri­val Am­gen, ap­pears to be enough for at least one of the most promi­nent phar­ma­cy play­ers to see their way through to drop­ping the com­plex ap­proval process that made this drug a non­event on the bot­tom line. Ex­press Scripts is giv­ing Sanofi/Re­gen­eron an ex­clu­sive place on their for­mu­la­ry — take that, Am­gen — with a pledge to pass along the sav­ings to its mem­bers through low­er out-of-pock­et ex­pens­es.

The blunt Re­gen­eron CEO Len Schleifer said the deal was “de­signed to break the grid­lock so that Pralu­ent is fi­nal­ly able to reach pa­tients most in need. U.S. car­di­ol­o­gists have ex­pe­ri­enced un­prece­dent­ed chal­lenges in se­cur­ing ac­cess for Pralu­ent for pa­tients who were clear­ly ap­pro­pri­ate, but were de­nied cov­er­age. This agree­ment sets a new stan­dard in in­dus­try and pay­er col­lab­o­ra­tion that we hope will serve as a mod­el for how to make in­no­v­a­tive med­i­cines more ac­ces­si­ble and af­ford­able.” 

And ICER chief Steven Pear­son of­fered his en­dorse­ment, hap­py to see some re­al ne­go­ti­at­ing on price and ac­cess. He not­ed:

Fol­low­ing a decades-long trend to­ward dys­func­tion and fin­ger-point­ing, the US health care sys­tem is be­gin­ning to ad­dress its drug pric­ing prob­lem through the emer­gence of a ‘grand bar­gain.’ When a man­u­fac­tur­er is will­ing to re­spon­si­bly price an in­no­v­a­tive med­i­cine in line with its clin­i­cal ben­e­fits, pay­ers should rec­i­p­ro­cate by re­mov­ing the hur­dles that can pre­vent pa­tients from get­ting the drug.

Mike Suesser­man

Sanofi/Re­gen­eron and Am­gen have been duk­ing it out over who owns the patents on PC­SK9, but both have been es­sen­tial­ly side­lined by pay­ers’ per­sis­tent re­fusal to hit a green light on these drugs. With physi­cians star­ing at a pile of pa­per­work and re­peat­ed de­nials, these com­pa­nies nev­er had a chance at the orig­i­nal high price they want­ed to fetch. Re­al­i­ty dawned slow­ly, but the sun is com­ing up on a field that a host of an­a­lysts still res­olute­ly be­lieves is a block­buster mar­ket in the mak­ing.

“We’ve been out on the mar­ket close to three years,” says Mike Suesser­man, VP of the car­diometa­bol­ic and opthamol­o­gy busi­ness unit at Re­gen­eron. They’ve seen lots of feed­back along the way and iden­ti­fied what the crit­i­cal hur­dles are. This deal, he says, ad­dress­es those hur­dles.

“In that sense I think it’s a huge leap for­ward.”

You can bet that more such leaps for­ward are in the works as Am­gen looks to strike back on the phar­ma­cy front.

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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