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

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.