Philip­pines DOJ preps crim­i­nal charges for Sanofi, health of­fi­cials in­volved in the Deng­vax­ia mess

The furor over Sanofi’s Deng­vax­ia con­tin­ues to roil the Philip­pines.

More than a year af­ter Sanofi con­ced­ed that the dengue vac­cine might raise the risk of a se­ri­ous re­ac­tion for the 800,000-plus chil­dren who were vac­ci­nat­ed in 2016, of­fi­cials in the De­part­ment of Jus­tice say they have grounds for in­dict­ing Sanofi ex­ecs along­side for­mer Health Sec­re­tary Janette Garin and 9 more health of­fi­cials in­volved in the vac­ci­na­tion pro­gram on crim­i­nal charges of reck­less im­pru­dence re­sult­ing to homi­cide.

Sanofi has con­sis­tent­ly main­tained it did noth­ing wrong in rolling out Deng­vax­ia, but af­ter tout­ing their long run­ning in-house pro­gram and plans to earn bil­lions on the vac­cine around the world, they have noth­ing but a mess to show for it — along with pend­ing crim­i­nal in­dict­ments.

Their state­ment to­day:

We strong­ly dis­agree with the find­ings made against Sanofi and some of its em­ploy­ees and we will vig­or­ous­ly de­fend them.  As this is an on­go­ing pro­ceed­ing, it would not be ap­pro­pri­ate for us to com­ment fur­ther at this time.

Even be­fore Sanofi spot­light­ed the risk as­so­ci­at­ed with the vac­cine, in­de­pen­dent in­ves­ti­ga­tors had de­ter­mined on their own that the phar­ma gi­ant had the da­ta in hand to un­der­stand that the vac­cine raised the risk of a se­vere re­ac­tion to any­one who had been vac­ci­nat­ed and then ex­posed to the virus for the first time. 

In the first dengue in­fec­tion, peo­ple typ­i­cal­ly get mild flu-like symp­toms as their body gen­er­ates an­ti­bod­ies that fight off the virus, which the vac­cine is al­so de­signed to kick up. Three years ago, Scott Hal­stead and Philip Rus­sell point­ed to those an­ti­bod­ies as a se­vere threat to any­one who then is ex­posed to wild type dengue for the first time. At that point they as­sist the virus in a process called an­ti­body-de­pen­dent en­hance­ment, or ADE. And the most se­vere cas­es can lead to in­ter­nal bleed­ing, a res­pi­ra­to­ry cri­sis, or­gan fail­ure and death.

The threat Deng­vax­ia pos­es was al­so spot­light­ed in a ma­jor study pub­lished in Sci­ence just a few weeks af­ter the Philip­pines got busy vac­ci­nat­ing peo­ple. And the re­searchers, in­clud­ing Neil Fer­gu­son, di­rec­tor of the MRC Cen­ter for Out­break Analy­sis and Mod­el­ing at Im­pe­r­i­al Col­lege Lon­don, of­fered some wide­ly dis­cussed, stark warn­ings of ADE.

“You’d have in­creas­es in hos­pi­tal­ized dengue cas­es,” co-au­thor Derek Cum­mings, a pro­fes­sor at the Uni­ver­si­ty of Flori­da, told CNN at the time. “It would be ex­act­ly the op­po­site of what you in­tend to do.”


Philip­pine Health of­fi­cials and Sanofi Pas­teur ex­ec­u­tives take their oaths be­fore the Philip­pine Sen­ate probe in 2017. ap im­ages

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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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.

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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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.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.


Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.


Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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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.