Oh Cana­da! There is no San­ta Claus to the north giv­ing out cheap drugs to US pa­tients

Bioreg­num Opin­ion Col­umn by John Car­roll

This morn­ing HHS Sec­re­tary Alex Azar took an­oth­er step to­ward open­ing the door to drugs im­port­ed from Cana­da. The still-de­vel­op­ing pol­i­cy ini­tia­tives pave the way to get­ting states to set up pro­grams for im­port­ing less ex­pen­sive drugs, as well as set­ting up a path for drug­mak­ers to bring in ther­a­pies sold abroad.

With less than a year to go to the elec­tion, you could say Pres­i­dent Don­ald Trump has a vest­ed in­ter­est in cuff­ing the bio­phar­ma in­dus­try — as he promised from the start — be­fore he goes back to vot­ers sell­ing 4 more years in the White House.

But let’s get re­al here. Any­one who thinks you can out­source the drug pric­ing is­sue to Cana­da, and get them to act as a proxy for the Amer­i­can mar­ket, has got to be dream­ing.

I’m not go­ing in­to the safe­ty is­sue, the way lob­by­ists want to when it comes to drug im­por­ta­tion. If you stick with rep­utable dis­trib­u­tors in Cana­da, there won’t be a safe­ty is­sue. This ar­gu­ment is about mon­ey, and that’s where we need to fo­cus.

I’ve had se­ri­ous con­ver­sa­tions with se­nior phar­ma ex­ecs who ap­pear per­fect­ly will­ing to sac­ri­fice Eu­ro­pean rev­enue if nec­es­sary in or­der to safe­guard their all-im­por­tant US mar­kets. What do you think these phar­ma com­pa­nies would do with their small Cana­di­an mar­ket­ing ops if they threat­ened US prof­it mar­gins?

If a Cana­di­an ne­go­tia­tor is stand­ing in as a sub­sti­tute to rep­re­sent state mar­kets in the US, their drug prices are go­ing to go sky high or their sup­ply will be cur­tailed. And Cana­da is not go­ing to al­low that. Once the sup­ply of a sin­gle drug is crimped, the hue and cry in that coun­try would be im­mense. They want to pre­serve low­er prices and ac­cess for Cana­di­ans, not go on some cru­sade to ex­tend that to the US. And if glob­al phar­ma play­ers can’t rein in a rogue op­er­a­tion, what hap­pens to the con­tracts they re­ly on to do busi­ness?

Yeah.

In­ter­est­ing­ly, the New York Times re­port on the pol­i­cy de­vel­op­ment to­day says a 2003 law won’t even al­low for im­por­ta­tion of high-priced bi­o­log­ics like Hu­mi­ra — the thorn in the side of law­mak­ers. Ab­b­Vie jacked up that price year af­ter year to cre­ate a cash cow it re­lied on to get them to the next chap­ter — which turned out to be the Al­ler­gan buy­out. And Cana­da can’t help.

This is a non-starter. It al­ways has been for the 20 years it’s been de­bat­ed. Yet it re­mains a spot­light is­sue, un­der­scor­ing the pauci­ty of new ideas when it comes to the much-need­ed task of re­form­ing the pric­ing sys­tem in the US. Drug af­ford­abil­i­ty and ac­cess is a huge is­sue in the US, where large groups of pa­tients can’t af­ford their end of the bill. Let’s not triv­i­al­ize the cri­sis by promis­ing a so­lu­tion from Cana­da that will nev­er come.

So­cial im­age: Shut­ter­stock

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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