In a win for in­dus­try, Trump ad­min­is­tra­tion is­sues scathing re­view of Pelosi drug pric­ing bill

Pres­i­dent Don­ald Trump wants it both ways — cheap­er drugs and vig­or­ous in­no­va­tion. Ear­li­er this year, the De­moc­rats’ re­vealed their drug pric­ing bill, which is en­gi­neered to em­pow­er the HHS to ne­go­ti­ate prices for se­lect drugs. The White House has now emerged as one of its harsh­est crit­ics.

“Heavy-hand­ed gov­ern­ment in­ter­ven­tion may re­duce drug prices in the short term, but these sav­ings are not worth the long-term cost of Amer­i­can pa­tients los­ing ac­cess to new life­sav­ing treat­ments,” the Trump ad­min­is­tra­tion wrote in an analy­sis post­ed on Tues­day, pro­vid­ing a boost to the in­dus­try that has thrived in its large­ly Lais­sez-faire ecosys­tem.

Re­pub­li­cans and De­moc­rats both ar­gue drug prices in the Unit­ed States are too high. The De­moc­rats’ drug pric­ing bill — HR 3, un­veiled by Speak­er Nan­cy Pelosi in Sep­tem­ber — could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face an ex­cise tax of up to 95% of sales, which in turn could trig­ger fi­nan­cial loss­es due to drug sales.

Law­mak­ers left, right and cen­ter are de­vis­ing their own plans to help Amer­i­can pa­tients nav­i­gate the ex­pen­sive health­care sys­tem — but so far no­body can agree on just how to make it great again. Mean­while, the Pelosi leg­is­la­tion ig­nit­ed crit­i­cism from some Re­pub­li­cans and De­moc­rats, who fear it would chill in­vest­ment in phar­ma­ceu­ti­cal re­search and sti­fle in­no­va­tion. That’s the track tak­en by Big Phar­ma — which holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self. A clutch of biotech ven­ture cap­i­tal­ists who claim to have in­vest­ed a com­bined $20 bil­lion in the in­dus­try al­so ex­pressed their frus­tra­tion with the bill, sug­gest­ing in­no­va­tion will be un­jus­ti­fi­ably com­pro­mised.

A pre­lim­i­nary analy­sis pub­lished by the Con­gres­sion­al Bud­get Of­fice (CBO) in Oc­to­ber es­ti­mat­ed the bill would shave fed­er­al di­rect spend­ing for Medicare by $345 bil­lion over the 2023-2029 pe­ri­od, but cau­tioned that the re­duc­tion in drug­mak­er rev­enues in the ex­pect­ed range of $500 bil­lion to $1 tril­lion would cul­mi­nate in ap­prox­i­mate­ly 8 to 15 few­er new drugs hit­ting the mar­ket over the in­com­ing decade.

But it looks like no­body has quite worked out how many drugs the loss of $500 bil­lion to $1 tril­lion could po­ten­tial­ly take away from the Amer­i­can pub­lic. On Tues­day, the White House is­sued a state­ment, sug­gest­ing the Pelosi bill could re­sult in as many as 100 few­er drugs from reach­ing the mar­ket over the next decade, cit­ing the cal­cu­la­tions of the Coun­cil of Eco­nom­ic Ad­vis­ers (CEA), an agency with­in the ex­ec­u­tive of­fice of the Pres­i­dent.

That 100 num­ber is based on the as­sump­tion that phar­ma­ceu­ti­cal com­pa­nies typ­i­cal­ly spend 15% to 20%  of their rev­enue on R&D, which would im­ply a loss of $75 bil­lion to $200 bil­lion in R&D re­sources and the ba­sis that get­ting a drug from dis­cov­ery to ap­proval costs $2 bil­lion. Us­ing an­oth­er set of as­sump­tions, the CEA cal­cu­lat­ed the bill would al­so re­duce Amer­i­cans’ av­er­age life ex­pectan­cy by about four months.

On the flip side, the bill would save the fed­er­al gov­ern­ment an av­er­age of $34.5 bil­lion per year for the next 10 years, the White House re­port said. How­ev­er, by em­ploy­ing ‘stan­dard’ meth­ods of de­ter­min­ing health gains, the group pre­dict­ed the fall in health out­comes could cost be­tween $375 bil­lion to $1 tril­lion per year over the next decade, sug­gest­ing the bills “long-term health costs are at least 10 times larg­er than the short-term sav­ings.”

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

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FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.