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

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.