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

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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As­traZeneca gives up on late-stage IL-23 drug due to tri­al de­lays, com­pet­i­tive land­scape

AstraZeneca is shelving an IL-23 antibody that’s been through a winding journey around pharma — including stops at Amgen and Allergan — and putting an end to Phase II and III trials testing the drug for inflammatory bowel disease.

“The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve,” a press release reads.

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