SCO­TUS just turned its back on Al­ler­gan’s le­gal ma­neu­ver to take a blow at in­ter partes re­view. What did you ex­pect?

It’s fi­nal­ly over.

Bioreg­num Opin­ion Col­umn by John Car­roll

From the very be­gin­ning, Al­ler­gan’s at­tempt to safe­guard its block­buster Resta­sis fran­chise by hand­ing over the patents to a Mo­hawk tribe in New York looked like a bad par­o­dy of a le­gal loop­hole ma­neu­ver. Now it’s a dead par­o­dy, af­ter the Supreme Court on Mon­day shunned the com­pa­ny’s at­tempt to take its ar­gu­ment to the high­est court in the land with a sin­gle line.

The tribe’s im­mu­ni­ty would safe­guard the patents from the in­ter partes re­view process, they rea­soned, and they could ba­si­cal­ly lease back con­trol of the drug while steer­ing clear of a se­ri­ous threat from gener­ic drug­mak­ers.

Brent Saun­ders speak­ing at an End­points event in 2017 End­points News

But this wasn’t just de­fend­ed by the at­tor­neys, who are paid to make ar­gu­ments of all kinds. Al­ler­gan CEO Brent Saun­ders took up the stan­dard and led the charge him­self. He hurt him­self at every turn, look­ing every bit like a Big Phar­ma ex­ec who would try any gim­mick to pro­tect the cash cow. This was in 2017, as the in­dus­try’s rep was tak­ing a turn for the worse — while the pub­lic and law­mak­ers be­gan to raise a clam­or over drug prices.

Al­ler­gan stuck to its le­gal guns, and the in­dus­try rep slid south right along with their ar­gu­ment.

“We can cer­tain­ly agree to dis­agree,” Saun­ders told me back when this got start­ed, adding adamant­ly that “every­thing we have done here is com­plete­ly con­sis­tent with our so­cial con­tract.”

You don’t hear much about the so­cial con­tract these days, which dates back to the com­pa­ny’s at­tempt to get top play­ers to show some re­straint on drug prices. Al­ler­gan raised many of its drug prices 9.9% at the be­gin­ning of the year, with­in the guide­lines of the so­cial con­tract, and all you hear from the pub­lic now is a de­mand to cut prices.

Aside from a few biotech al­lies who are no big­ger fans of IPR than Al­ler­gan, though, the biotech had few cham­pi­ons to help in the fight. Promi­nent law­mak­ers sin­gled them out to scorn­ful­ly ac­cuse them of try­ing to run a sham. Ac­tivists would add this to their list of trans­gres­sions by Saun­ders as the stock price de­clined.

In­stead of de­feat­ing the IPR process — elim­i­nat­ing a third par­ty chal­lenge to patents that has be­dev­iled bio­phar­ma for years — Al­ler­gan has helped en­shrine it in fed­er­al law. The ap­peals court sided with the patent board, con­clud­ing that IPR was more in line with ex­ec­u­tive branch en­force­ment de­ci­sions than pri­vate par­ty lit­i­ga­tion in fed­er­al court — where im­mu­ni­ty could be ap­plied. 

On Mon­day, the Supreme Court wrote off Al­ler­gan’s case, deny­ing their at­tempt to ar­gue the case in front of the 9 jus­tices. The ap­peals court de­ci­sion stands. The Resta­sis for­tune is slat­ed for dec­i­ma­tion, with My­lan and Te­va push­ing to get out cheap copy­cats. A fed­er­al judge had in­val­i­dat­ed the patents in the fall of 2017, diss­ing the Mo­hawk move as il­le­git­i­mate.

Enough said.


Im­age: Richard Drew AP

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link. 

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

Sil­i­con Val­ley's most an­tic­i­pat­ed slide deck just dropped. What does it mean for bio­phar­ma's dig­i­tal teams?

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.

News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.