As JP­Mor­gan mad­ness sub­sides, De­moc­rats will un­veil a leg­isla­tive pack­age to ad­dress drug price hikes

On the night be­fore the start of JP Mor­gan — a con­fer­ence where bio­phar­ma ex­ec­u­tives big and small waxed lyri­cal about in­no­va­tion, adorned with name badges fea­tur­ing a gold DNA cap­sule — Pres­i­dent Don­ald Trump tweet­ed his dis­plea­sure that drug­mak­ers were not hon­or­ing their promis­es to rein in prices. He wasn’t wrong. Da­ta sug­gest drug­mak­ers have re­turned to busi­ness as usu­al. And now, af­ter De­moc­rats clawed back con­trol of the House, they’re ex­pect­ed to un­veil a leg­isla­tive pack­age to­day to ad­dress what the White House has so far at­tempt­ed in vain to do: cut prices for pre­scrip­tion drugs.

At least three bills are be­ing tout­ed in the pack­age — in­clud­ing one re­vealed last No­vem­ber from Sen­a­tor Bernie Sanders and Rep­re­sen­ta­tive Ro Khan­na that as­serts Amer­i­cans should not pay more for pre­scrip­tion drugs than the me­di­an price in five ma­jor coun­tries, re­sem­bling a Trump ad­min­is­tra­tion pro­pos­al pre­sent­ed the pre­ced­ing month. Oth­er parts of the leg­is­la­tion pro­pos­es al­low­ing HHS to ne­go­ti­ate prices for Medicare Part D di­rect­ly with drug­mak­ers, in­stead of mid­dle­men like phar­ma­cy ben­e­fit man­agers — as well as im­port­ing med­i­cines at a low­er price from coun­tries such as Cana­da.

Last year, un­der pres­sure from the Trump ad­min­is­tra­tion and in re­sponse to pub­lic out­rage, a num­ber of high pro­file drug­mak­ers made pledges to freeze prices. Since then, the Trump ad­min­is­tra­tion has al­so in­tro­duced two pro­pos­als to tem­per prices. But de­spite in­ten­si­fy­ing po­lit­i­cal and me­dia scruti­ny, drug­mak­ers have re­turned to hikes on at least a por­tion of their port­fo­lio. That in turn has trig­gered an in­tense pub­lic back­lash, which is dri­ving this new leg­isla­tive on­slaught.

The phar­ma­ceu­ti­cal in­dus­try, along with its well con­nect­ed lob­by, has ve­he­ment­ly fought against pro­pos­als to im­port over­seas prices, sug­gest­ing such schemes will sti­fle in­no­va­tion and po­ten­tial­ly ush­er un­safe med­i­cines in­to the coun­try.

Stephen Ubl, CEO of PhRMA, at an End­points News event at the 2019 JP Mor­gan con­fer­ence Jeff Ru­mans for End­points News

Click on the im­age to see the full-sized ver­sion

How­ev­er, da­ta show that de­spite the high cost of health­care, the Unit­ed States ac­tu­al­ly per­forms worse across var­i­ous health mea­sures ver­sus a num­ber of oth­er high-in­come na­tions. And Amer­i­cans them­selves are des­per­ate­ly seek­ing change: at­tack­ing drug price goug­ing is one of the few sub­jects that has wide­spread bi­par­ti­san sup­port. Ac­cord­ing to a re­cent Politi­co/Har­vard poll, an over­whelm­ing ma­jor­i­ty of Amer­i­cans ranked ad­dress­ing the cost of med­i­cines as a top pri­or­i­ty for the new Con­gress.

On Wednes­day, for­mer Lil­ly ex­ec­u­tive and HHS sec­re­tary Alex Azar tweet­ed: “For those lis­ten­ing in the phar­ma­ceu­ti­cal in­dus­try: The list price in­creas­es must stop. Prices must start com­ing down.”

But an­a­lysts are not as con­vinced po­lit­i­cal pres­sure will have the im­pact some an­tic­i­pate. Bern­stein’s Ron­ny Gal in a note in No­vem­ber 2018 wrote: “phar­ma does not have to be as nice to PO­TUS now that CMS has pol­i­cy ideas that are an­ti­thet­i­cal to in­dus­try in­ter­est…At the very least, threat­en­ing to raise prices gives in­dus­try a bar­gain­ing chip to ne­go­ti­ate some of these poli­cies away.” More re­cent­ly in Jan­u­ary, Cowen an­a­lysts pub­lished a sur­vey of US drug buy­ers — in­clud­ing HMOs, PBMs and hos­pi­tals who col­lec­tive­ly bought more than $42 bil­lion in drugs in 2017 — to as­cer­tain the mo­men­tum of US drug prices over the next 3 years.

“Re­spon­dents ex­pect U.S. brand drug prices will con­tin­ue to rise over the next 3 years, at a rate sim­i­lar to the past,” the an­a­lysts found.

When asked about the flur­ry of de­bate sur­round­ing the is­sue of pric­ing, Bio­Marin chief Jean-Jacques Bi­en­aime said “It’s not a re­al prob­lem; it’s all pol­i­tics” in an in­ter­view with Bloomberg on the eve of JP Mor­gan.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.