Mark Alles, former CEO of Celgene, testifies by video conference before the House Committee on Oversight and Reform on Wednesday (Pool via AP)

Dems slam drug pric­ing strate­gies as 18-month probe comes to an end

The House Over­sight Com­mit­tee held a pair of hear­ings this week on drug prices. And the De­moc­rats on the pan­el did not hold back.

Ex­ec­u­tives from Bris­tol My­ers Squibb (and Cel­gene), Te­va, Am­gen, No­var­tis and Mallinck­rodt tes­ti­fied be­fore Con­gress in the cul­mi­na­tion of an 18-month in­ves­ti­ga­tion in­to ris­ing drug prices.  The pro­ceed­ings, built on work from the late Eli­jah Cum­mings, pro­duced more than one mil­lion doc­u­ments from the com­pa­nies and large­ly con­clud­ed that prof­it was the main dri­ving force be­hind the in­creas­es.

“The drug com­pa­nies are bring­ing in tens of bil­lions of dol­lars in rev­enues, mak­ing as­tro­nom­i­cal prof­its, and re­ward­ing their ex­ec­u­tives with lav­ish com­pen­sa­tion pack­ages—all with­out any ap­par­ent lim­it on what they can charge,” com­mit­tee chair Car­olyn Mal­oney (D-NY) wrote.

The hear­ings were split up over two days, with Cel­gene, BMS and Te­va ex­ecs ap­pear­ing Wednes­day and Am­gen, No­var­tis and Mallinck­rodt tes­ti­fy­ing Thurs­day. Cel­gene was ac­quired by BMS last year, and though BMS CEO Gio­van­ni Caforio tes­ti­fied, most of the ques­tion­ing dealt with Cel­gene’s busi­ness prac­tices be­fore the ac­qui­si­tion.

Be­fore Wednes­day’s meet­ing, the com­mit­tee re­leased two re­ports that out­lined how Cel­gene and Te­va me­thod­i­cal­ly raised prices of the block­busters revlim­id and co­pax­one, re­spec­tive­ly, in or­der to meet sales tar­gets. The re­port cites one in­stance from March 2014, when Cel­gene ex­ec Mark Alles — who lat­er be­came CEO — ex­pressed dis­ap­point­ment in Revlim­id’s sales that quar­ter and di­rect­ed a 4% price in­crease in re­sponse.

“Mr. Alles emailed his team to en­sure that the price in­crease would go in­to ef­fect as quick­ly as pos­si­ble to have the max­i­mum im­pact on sales,” the re­port wrote. Alles lat­er said in an email, “Can we take the in­crease tonight so that it im­pacts sales be­gin­ning to­mor­row?”

Af­ter Cel­gene ap­proved that change, it im­ple­ment­ed the in­crease the same evening.

Te­va, mean­while, con­tract­ed with mid­dle­men to try to block low­er-cost gener­ics from reach­ing the mar­ket and en­gaged in high-dol­lar lob­by­ing ef­forts to con­vince doc­tors to keep us­ing their more ex­pen­sive drugs, ac­cord­ing to the re­ports. About 55% of Te­va’s 2019 rev­enue came from the gener­ics mar­ket.

On Thurs­day, the oth­er three com­pa­nies en­tered the ring and saw re­ports on their own busi­ness­es prac­tices re­leased. No­var­tis, like Te­va, was sin­gled out for its ap­par­ent open­ness to dis­cussing mid­dle­man con­tracts as a way to keep gener­ic com­pe­ti­tion at bay for Gleevec. The com­mit­tee al­so found that No­var­tis in­creased Gleevec’s price at a faster rate to­ward the end of their mar­ket ex­clu­siv­i­ty win­dow.

Am­gen was not found to have en­gaged in such mid­dle­men strate­gies when pric­ing En­brel. Rather, the com­mit­tee said Am­gen con­duct­ed “shad­ow pric­ing” plans by at­tach­ing their En­brel in­creas­es to those of its ma­jor com­peti­tor, Ab­b­Vie’s Hu­mi­ra. The com­mit­tee chid­ed Am­gen for not set­ting their prices low­er than Hu­mi­ra to gain mar­ket share as would be nor­mal­ly ex­pect­ed in a com­pet­i­tive mar­ket, it said.

“Short­ly af­ter Ab­b­Vie in­creased the price of Hu­mi­ra by 9.7% in Jan­u­ary 2018, Am­gen ex­e­cut­ed an iden­ti­cal 9.7% price in­crease, more than dou­ble what it had orig­i­nal­ly planned,” one of the re­ports said.

Mallinck­rodt faced ques­tions about the pric­ing tac­tics of its HP Ac­thar Gel and ac­qui­si­tion of Quest­cor, which owned the rights to the drug.

Quest­cor raised the price of Ac­thar to $31,000 per vial, up from $40 in 2001. Mallinck­rodt then in­creased the price by an­oth­er $8,200.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Spar­ingVi­sion rais­es $52M to kick off long jour­ney for a next-gen gene ther­a­py that goes much, much broad­er than Lux­tur­na

Until Spark Therapeutics’ pioneering gene therapy, Luxturna, came along, patients with retinitis pigmentosa had few treatment options. Even after it was approved, though, the majority were left with the exact same options.

Because it’s targeting mutations in a specific gene known as RPE65, Luxturna can only address 2 to 3% of the entire RP population, Stephane Boissel told Endpoints News.

Boissel is the newly-minted CEO of SparingVision, a French biotech co-founded by José-Alain Sahel and Thierry Léveillard at the Institut de la Vision. They have their sight set on a new kind of AAV construct — a next-generation gene therapy if you will — that can treat all patients of RP independent of genetic mutations.

Derek Chalmers, Cara Therapeutics CEO

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Joe Biden (Carolyn Kaster, AP Images)

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

From an ill-fated proposal to ban rebates for pharmacy benefit managers to an executive order demanding a “most-favored-nation price” for Medicare, if nothing else President Donald Trump has introduced Americans to a flurry of ideas to rein in pharma, an industry he once accused of “getting away with murder.” And now we’re getting the first glimpse of what a Joe Biden presidency might mean for prescription drug pricing.