There’s one end­point that the boom­ing bio­phar­ma in­dus­try has failed at mis­er­ably: fi­nan­cial tox­i­c­i­ty

Bioreg­num Opin­ion Col­umn by John Car­roll

One of the big themes in R&D over the past few years has been the on­slaught of spend­ing on de­vel­op­ing new on­col­o­gy drugs. The FDA has en­cour­aged ear­ly ap­provals, open­ing the door to small­er tri­als as an on­slaught of in­vest­ment cash made it pos­si­ble for small play­ers to go the dis­tance.

Big Phar­ma, mean­while, has en­joyed the com­fort of bet­ter sci­en­tif­ic in­sights and the ar­rival of some huge new PD-1s on the scene. Next up: A tsuna­mi of com­bo ther­a­pies com­ing at you from the US, Eu­rope and Chi­na — the new fac­tor in drug hunt­ing.

For the in­dus­try, that means a ma­jor new source of rev­enue from com­ing ther­a­pies. For US pa­tients, that means a much bet­ter shot at longer sur­vival and pos­si­bly even a cure. As well as bank­rupt­cy.

Wait. What?

Re­searchers just pub­lished a new study in The Amer­i­can Jour­nal of Med­i­cine high­light­ing that 42% of can­cer pa­tients ex­haust their sav­ings with­in 2 years of di­ag­no­sis. And 62% of the 9.5 mil­lion can­cer pa­tients they re­viewed were in debt af­ter ther­a­py, with 40% to 85% quit­ting work due to can­cer. Af­ter 4 years of ther­a­py, 38.2% were in­sol­vent.

You hear a lot every time a new drug is ap­proved about what drug com­pa­nies are do­ing to make their ther­a­pies ac­ces­si­ble, but the sim­ple fact is that in the US large per­cent­ages of pa­tients are be­ing crushed by the price of brand­ed drugs. And while the new drugs be­ing in­tro­duced may be more im­por­tant than ever, the un­var­nished truth is that ba­sic pric­ing strate­gies are more about max­i­miz­ing rev­enue than ac­com­mo­dat­ing pa­tients.

The re­sult­ing fi­nan­cial tox­i­c­i­ty is enor­mous.

Let’s re­mem­ber that one of the rea­sons we’re see­ing all the in­vest­ment cash pour­ing in is that Wall Street has em­braced a big wave of biotech IPOs. And that’s where ex­ecs are fo­cused when they price new drugs.

That’s not a wild guess, ei­ther.

This is the bot­tom line re­searchers tot­ted up af­ter dis­cussing pric­ing strate­gies on new drugs for mul­ti­ple scle­ro­sis with 4 biotech ex­ecs, pub­lished in Neu­rol­o­gy this week.

Par­tic­i­pants con­sis­tent­ly stat­ed that ini­tial price de­ci­sions were dic­tat­ed by the price of ex­ist­ing com­peti­tors in the mar­ket. Rev­enue max­i­miza­tion and cor­po­rate growth were dri­vers of price es­ca­la­tions in the ab­sence of con­tin­ued mar­ket pen­e­tra­tion. Low­er rev­enue pre­dic­tions out­side the Unit­ed States al­so in­formed pric­ing strate­gies. The grow­ing com­plex­i­ty and clout of drug dis­tri­b­u­tion and sup­ply chan­nels were al­so cit­ed as con­tribut­ing fac­tors. Al­though de­ci­sions to raise prices were mo­ti­vat­ed by the need to at­tract in­vest­ment for fu­ture in­no­va­tion, re­coup­ing drug-spe­cif­ic re­search and de­vel­op­ment costs as a jus­ti­fi­ca­tion was not strong­ly en­dorsed as hav­ing a sig­nif­i­cant in­flu­ence on pric­ing de­ci­sions.

So while the in­dus­try likes to talk a lot about the pric­ing lev­els need­ed to back in­no­va­tion, it’s just not an ac­cu­rate re­flec­tion of re­al­i­ty.

In just a few weeks, we’re go­ing to wake up to a new year that will be dom­i­nat­ed by drug pric­ing dis­cus­sions. We’re go­ing to be do­ing some of this our­selves at JP Mor­gan.

The in­dus­try still has a shot at com­ing up with some kind of work­able re­form on drug prices. Bar­ring a mar­ket so­lu­tion, though, you can ex­pect plen­ty of un­work­able and de­struc­tive sug­ges­tions on drug im­por­ta­tion and com­pul­so­ry li­cens­ing and more. And some­day, law­mak­ers will do some­thing about it.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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