As Pralu­ent Q1 sales miss Wall Street ex­pec­ta­tions, FDA ex­pands drug's la­bel to re­flect CV risk re­duc­tion

Months af­ter spar­ring ri­vals Am­gen $AMGN and part­ners Re­gen­eron $REGN and Sanofi $SNY slashed the prices of their re­spec­tive PC­SK9 in­hibitors by 60% to $5,850 in a bid to im­prove tepid sales of the cho­les­terol drugs, the lat­ter has se­cured an ad­di­tion­al la­bel that sup­ports their prod­uct’s abil­i­ty to re­duce se­ri­ous car­dio­vas­cu­lar events.

Re­gen­eron/Sanofi’s Pralu­ent and Am­gen’s Repatha were orig­i­nal­ly ap­proved in 2015 amidst much fan­fare, and 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 ($14,000) that led to low­er-than-ex­pect­ed adop­tion, de­spite lat­er tri­als that demon­strat­ed the PC­SK9 in­hibitors al­so sig­nif­i­cant­ly cut the risk of heart at­tacks and strokes.

Am­gen’s Fouri­er study showed Repatha could sig­nif­i­cant­ly re­duce the risk of ma­jor car­dio­vas­cu­lar events, but Re­gen­eron/Sanofi’s Odyssey Out­comes study last year showed that Pralu­ent not on­ly sig­nif­i­cant­ly cut the num­ber of car­dio­vas­cu­lar in­ci­dents, but al­so demon­strat­ed a clear re­duc­tion in deaths from any cause — a goal that elud­ed Am­gen when it un­veiled its Fouri­er da­ta in 2017.

In late 2017, Repatha’s la­bel was up­dat­ed by the FDA to re­flect that the drug could pre­vent heart at­tack, stroke and coro­nary revas­cu­lar­iza­tion in adults with es­tab­lished car­dio­vas­cu­lar dis­ease. On Fri­day, Pralu­ent’s la­bel was re­vised by the agency to show that the drug can pre­vent heart at­tack, stroke and un­sta­ble angi­na re­quir­ing hos­pi­tal­iza­tion in the same pa­tient pop­u­la­tion.

Bri­an Sko­r­ney

On Fri­day, Sanofi al­so re­port­ed $63 mil­lion in first-quar­ter Pralu­ent sales, “which failed to meet our/con­sen­sus ex­pec­ta­tions of $95 mil­lion/$83 mil­lion,” Baird’s Bri­an Sko­r­ney wrote in a note, adding that the French drug­mak­er had not­ed that US sales were down near­ly 27% year-over-year due to the price cut.

“How­ev­er, Sanofi con­tin­ues to ex­pect that Pralu­ent vol­umes will in­crease in the com­ing year, as they have seen greater up­take in the Medicare pop­u­la­tion since the launch of a low-cost ver­sion of the med­ica­tion,” Sko­r­ney said.

An­a­lysts have pre­dict­ed that the la­bel ex­pan­sion should re­vive Pralu­ent sales.

Am­gen is set to re­port its first quar­ter re­sults on Tues­day.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.

J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,800+ biopharma pros reading Endpoints daily — and it's free.