Re­gen­eron, Sanofi show re­straint on Dupix­ent price hike, but Pfiz­er’s hard charge con­tin­ues to spur calls for a rad­i­cal change-up

BIOREG­NUM — the view from John Car­roll

With the price of drugs front and cen­ter in Wash­ing­ton DC these days, Re­gen­eron and Sanofi are at­tract­ing ku­dos for their de­ci­sion to hold back the price hike on Dupix­ent to a mere 3%, which the phar­ma gi­ant notes is well with­in the rate of med­ical in­fla­tion — their cap on price in­creas­es.

Len Schleifer

Both of these com­pa­nies went through the ringer on PC­SK9 pric­ing — which have come down — and Re­gen­eron CEO Len Schleifer has been a con­sis­tent coun­sel for avoid­ing the big an­nu­al price in­creas­es that is at­tract­ing so much crit­i­cism these days.

Still, note that the over­all price trend is still point­ed up, not down, which is what Pres­i­dent Don­ald Trump promised re­cent­ly with his com­ment that the big chains were about to trig­ger “vol­un­tary mas­sive drops in prices.” That com­ment a month ago was a stumper for the phar­ma in­dus­try, which has promised no such thing. It’s al­so left it to HHS Sec­re­tary Alex Azar to ex­plain that that is not ex­act­ly the case.

And how.

Yes­ter­day’s news that Pfiz­er was in­creas­ing prices across a broad range of drugs has fo­cused at­ten­tion once again on a stan­dard in­dus­try prac­tice: look­ing to please in­vestors with a grow­ing bot­tom line that re­lies heav­i­ly on jack­ing up the cost of its port­fo­lio ther­a­pies. In Pfiz­er’s case, the Fi­nan­cial Times re­port­ed that the av­er­age price in­creas­es for 100 prod­ucts were around 9%, fit­ting un­der a 10% cap that most man­u­fac­tur­ers are hap­py to com­ply with.

That’s not mak­ing con­sumer ad­vo­cates very hap­py, as we saw yes­ter­day with a sug­ges­tion from the Pew Char­i­ta­ble Trusts that states could tax the rev­enue that phar­ma com­pa­nies bring in through tax hikes. So when Ab­b­Vie rais­es its price on Hu­mi­ra, an ag­ing stan­dard of care that ranks as the biggest mon­ey mak­er in the in­dus­try, a state like Cal­i­for­nia could levy a tax on the gain above the in­fla­tion rate.

Last year, re­marks Pew, av­er­age list prices for drugs jumped 6.4% and over­all in­fla­tion was lim­it­ed to a tiny frac­tion of that. They’re sug­gest­ing that states can claw back the cost of an in­crease by tax­ing any­thing over an in­fla­tion-ad­just­ed price — just the way pay­ers can re­quire a re­bate on the in­flat­ed cost.

For ex­am­ple, if a man­u­fac­tur­er in­creas­es the price of a drug from $100 to $115, but in­fla­tion is on­ly 2 per­cent, the in­fla­tion-ad­just­ed price is $102 and the man­u­fac­tur­er must pay Med­ic­aid a $13 in­fla­tion re­bate. A state tax on drug price in­creas­es could be de­signed to mir­ror the cal­cu­la­tions that de­ter­mine the Med­ic­aid in­fla­tion re­bate, re­duc­ing the com­pli­ance bur­den on drug man­u­fac­tur­ers.

The law cur­rent­ly al­lows man­u­fac­tur­ers to price drugs at will, giv­ing the feds no con­trol at all. States, says Pew, don’t have to stand idly by.

Look for the in­dus­try to bat back any­thing like that as fast as they can. The lob­by­ing groups rep­re­sent­ing the in­dus­try far pre­fer a self-polic­ing mech­a­nism while the Trump ad­min­is­tra­tion has tak­en a name-and-shame ap­proach to the most egre­gious price hikes — such as Cel­gene’s 20% hike on Revlim­id with­in one year.

Re­gen­eron and Sanofi — which have scored a slate of new ap­provals to push rev­enue growth — may yet win out with their ap­proach, but many of the biggest play­ers clear­ly don’t want to be bound by any such re­stric­tions. Not every­body has Re­gen­eron’s de­vel­op­ment skills, and some­body has to pay to make up for the in­no­va­tion gap. And with prices still climb­ing north, the de­bate over drug prices just con­tin­ues to heat up.


Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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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

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund; Bei­jing ar­rests ex-Bio­gen staffer who flew while in­fect­ed

For months now, the US government has doled out unprecedented grants to vaccine developers in hopes of speeding the completion of a Covid-19 candidate, even if that meant putting hundreds of millions or billions behind efforts that ultimately failed. Now, the European Union may do the same.

The EU is planning to use a $2.7 billion rainy day fund to make advance purchases of vaccine candidates, Reuters reports. The news comes a day after the Trump Administration reportedly settled on the five finalists for its Operation Warp Speed, all of whom will get significant funding and other US assistance to finish testing and scale up their vaccine candidates.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

Doug Throckmorton speaks via video conference to the Senate Finance Committee, June 2, 2020 (Andrew Caballero-Reynolds, AP Images)

FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

During a Senate Committee on Finance hearing Tuesday, officials from the FDA responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.

The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic.

Much of the criticism centered on the agency’s practice of giving foreign facilities advanced notice of inspections while most domestic surveillance inspections are unannounced, as well as US reliance on foreign drug manufacturing.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.