Vas Narasimhan has high hopes for No­var­tis' Chi­na dri­ve as a block­buster drug gets a nod

No­var­tis has clinched a Chi­na ap­proval for its block­buster pso­ri­a­sis drug Cosen­tyx — the first of more than 10 nov­el med­i­cines that it plans to in­tro­duce in the coun­try with­in the next few years.

The ap­proval ar­rives just six months af­ter fil­ing and amid No­var­tis’ oth­er high-pro­file over­tures to es­tab­lish it­self as a key for­eign phar­ma play­er in Chi­na, from team­ing up with lo­cal biotechs and en­list­ing do­mes­tic tech gi­ant Ten­cent for dis­ease man­age­ment pro­grams to open­ing a new bio­med­ical re­search cen­ter in Bei­jing.

Speak­ing at the Chi­na De­vel­op­ment Fo­rum — a well at­tend­ed con­fab fea­tur­ing fel­low phar­ma boss­es like Al­bert Bourla and Olivi­er Brandi­court — a few days ago, No­var­tis CEO Vas Narasimhan said thanks to on­go­ing reg­u­la­to­ry re­forms and sci­en­tif­ic ad­vances, he ex­pects Chi­na to be­come one of the top three mar­kets for No­var­tis by sales in the com­ing years.

“If I was asked a few years ago how the Chi­nese mar­ket is dif­fer­ent from the in­ter­na­tion­al mar­ket, I might have talked about many dif­fer­ences,” he told a lo­cal re­porter. “But these dif­fer­ences are dwin­dling. Chi­na’s drug in­dus­try and mar­ket are in­creas­ing­ly sim­i­lar to those in de­vel­oped coun­tries.”

Case in point: No­var­tis got NM­PA stamps on nine new drugs in the past two years alone, with a reg­u­la­to­ry time­line “at the same lev­el of what we see in the Unit­ed States or in Eu­rope,” he added in an in­ter­view with Chi­na Dai­ly.

Among the next slate of prod­ucts it plans to roll out, Narasimhan high­light­ed the po­ten­tial of cell and gene ther­a­pies, in­clud­ing No­var­tis’ pi­o­neer­ing CAR-T treat­ment for can­cer, Kym­ri­ah.

The high price tags of these cut­ting edge treat­ments, though, are bound to trig­ger new de­bates on pric­ing — and No­var­tis will be go­ing up against some en­trenched lo­cal play­ers in carv­ing out pieces of the mul­ti-bil­lion dol­lar pie.

Take Shang­hai Jun­shi for ex­am­ple. The new­ly pub­lic biotech (on HKEX), which scored ap­proval for Chi­na’s first home­grown PD-1 in­hibitor, re­cent­ly came out with its own sales fore­cast for its drug Tuo Yi: They ex­pect sales to peak in three to four years and bring in an­nu­al rev­enue of $1.5 bil­lion to $2.2 bil­lion (RMB 10 bil­lion – 15 bil­lion). The prof­it mar­gin, CEO Li Ning said, should be no less than 90%, ac­cord­ing to a re­port by S&P Glob­al.

Fo­cus­ing on drugs that fill spe­cif­ic gaps, and ap­peal­ing to Chi­nese pa­tients, then, could be key. And that’s some­thing No­var­tis has al­lud­ed to in their an­nounce­ment of Cosen­tyx’s ap­proval, which was based part­ly on da­ta from tri­als con­duct­ed in Chi­na.

“The av­er­age on­set age of pso­ri­a­sis in Chi­na is around 30, and many of the mod­er­ate-to-se­vere pa­tients are in their prime. This pop­u­la­tion plays an ir­re­place­able role in their fam­i­ly, work­place and so­ci­ety. Thus, treat­ment with high ef­fi­ca­cy, a good safe­ty pro­file and long-last­ing dis­ease con­trol is what we are look­ing for to help pa­tients get back to nor­mal life and work,” Jianzhong Zhang, for­mer pres­i­dent of Chi­nese So­ci­ety of Der­ma­tol­ogy, Chi­nese Med­ical As­so­ci­a­tion, was quot­ed in the re­lease. “Pos­i­tive Chi­na da­ta pre­sent­ed re­cent­ly makes us hope­ful for the clin­i­cal use of se­cuk­inum­ab in Chi­na. I hope to see Chi­nese pa­tients ben­e­fit from this in­no­v­a­tive treat­ment and be re­lieved from their ill­ness bur­den.”


Im­age: Vas Narasimhan at CDF. NO­VAR­TIS

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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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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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.

Ab­b­Vie touts new da­ta for Hu­mi­ra suc­ces­sor; Gilead inks dis­cov­ery deal

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

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. 

Adding mar­quee in­vestors, Black­Thorn bags $76M to back an AI-dri­ven strat­e­gy for pre­ci­sion neu­ro med­i­cine

As ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing loom ever larg­er in drug dis­cov­ery and de­vel­op­ment, a biotech op­er­at­ing at the “nexus” of tech­nol­o­gy and neu­ro­sciences has cashed in with $76 mil­lion in fresh fi­nanc­ing.

The big idea at Black­Thorn Ther­a­peu­tics is to do for neu­robe­hav­ioral dis­or­ders what ge­net­i­cal­ly tar­get­ed ther­a­py has done for on­col­o­gy: Re­de­fine pa­tient pop­u­la­tions by the un­der­ly­ing bi­ol­o­gy — dys­reg­u­lat­ed brain cir­cuits, or neu­rotypes — in­stead of symp­toms, there­by find­ing the pa­tients who are most like­ly to ben­e­fit at en­roll­ment phase.

Fol­low­ing CAR-T pi­o­neer­s' foot­steps, Tes­sa launch­es Chi­na JV in $120M deal

These days just about every biotech se­ri­ous about glob­al de­vel­op­ment — and not just com­mer­cial­iza­tion — has a Chi­na strat­e­gy. Tes­sa Ther­a­peu­tics, a Bay­lor as­so­ci­at­ed out­fit based out of Sin­ga­pore, is no ex­cep­tion.

Tak­ing a page out of the CAR-T pi­o­neers’ play­book, Tes­sa is es­tab­lish­ing a joint ven­ture with Chi­na-Sin­ga­pore Guangzhou Knowl­edge City, which is ini­tial­ly putting down $40 mil­lion for a 13% stake with $40 mil­lion more to come in a sec­ond stage. The biotech, which now re­tains an 87% con­trol, is al­so rolling out its own con­tri­bu­tions in two phas­es, start­ing with $20 mil­lion and all its tech­nol­o­gy li­cense rights for Chi­na.