Take­da claims PhI­II suc­cess in dengue vac­cine months af­ter Deng­vax­ia im­plo­sion for ri­val Sanofi

Take­da is one stride clos­er to reach­ing the siz­able mar­ket wait­ing for dengue vac­cines as it re­ports pos­i­tive top-line re­sults from a mas­sive Phase III tri­al.

The analy­sis, which con­sti­tutes the first of a three-part study, con­cludes that the com­pa­ny’s tetrava­lent dengue vac­cine TAK-003 was ef­fi­ca­cious at 15 months in pre­vent­ing dengue fever caused by any of the four serotypes of the virus, there­by meet­ing the pri­ma­ry end­point. And while they are sav­ing the de­tails for a peer-re­viewed jour­nal, Take­da $TAK re­searchers say the vac­cine was “well tol­er­at­ed with no sig­nif­i­cant safe­ty con­cerns to date.”

Ra­jeev Venkayya

The safe­ty el­e­ment is par­tic­u­lar­ly im­por­tant giv­en the fresh mem­o­ries of a pub­lic health con­tro­ver­sy that Sanofi was mired in in­volv­ing the use of its pi­o­neer­ing dengue vac­cine in a ma­jor vac­ci­na­tion cam­paign in the Philip­pines. Giv­en to any­one who had not al­ready been in­fect­ed, Deng­vax­ia left peo­ple vul­ner­a­ble to se­vere, life-threat­en­ing dengue in the event they were sub­se­quent­ly in­fect­ed by wild type dengue. As a re­sult, Sanofi lim­it­ed its use to pro­tect peo­ple who have had a pri­or in­fec­tion — but stopped short of is­su­ing re­funds.

Deng­vax­ia was the first ap­proved vac­cine for the mos­qui­to-borne vi­ral dis­ease, and a block­buster-to-be that cost $1.5 bil­lion over 20 long years to de­vel­op. Ini­tial sales were a dis­ap­point­ment even at its peak in 2016, and in the first 6 months of the year 2018 Sanofi re­port­ed €1 mil­lion in sales rev­enue, down 94.4% from the year be­fore.

Derek Wal­lace

Though care­ful not to draw di­rect com­par­isons, Derek Wal­lace, vice pres­i­dent and glob­al dengue pro­gram head from Take­da, told End­points News that its study was de­signed dif­fer­ent­ly than oth­er dengue vac­cine tri­als so far.

We specif­i­cal­ly de­signed our Phase 3 vac­cine ef­fi­ca­cy tri­al to as­sess the safe­ty and ef­fi­ca­cy against all four serotypes and for both dengue naïve and ex­posed in­di­vid­u­als. Base­line blood sam­ples were col­lect­ed from all in­di­vid­u­als par­tic­i­pat­ing in the tri­al to al­low for eval­u­a­tion of safe­ty and ef­fi­ca­cy based on serosta­tus. The struc­ture of our vac­cine can­di­date, the unique im­muno­genic­i­ty pro­file elicit­ed by it and the rapid de­vel­op­ment of a four-serotype an­ti­body re­sponse fol­low­ing im­mu­niza­tion in most naïve and pre­vi­ous­ly-ex­posed in­di­vid­u­als are rea­sons that we be­lieve TAK-003 has a dif­fer­ent safe­ty and ef­fi­ca­cy pro­file rel­a­tive to the cur­rent­ly-li­censed dengue vac­cine.

While prep­ping a more ex­ten­sive re­view of this da­ta on TAK-003, Ra­jeev Venkayya, pres­i­dent of Take­da’s glob­al vac­cine busi­ness unit, said in a state­ment that they will al­so be “ad­vanc­ing the clin­i­cal de­vel­op­ment, com­mer­cial man­u­fac­tur­ing, and stake­hold­er con­sul­ta­tions to sup­port a po­ten­tial fu­ture glob­al launch of the vac­cine.”

Parts 2 and 3 of the TIDES tri­al — the largest vac­cine tri­al at 20,000 pa­tients, ac­cord­ing to Take­da — will as­sess sec­ondary end­points in six months and longterm safe­ty with three years, re­spec­tive­ly. Tri­al sites are lo­cat­ed in dengue-en­dem­ic ar­eas in Latin Amer­i­ca (Brazil, Colom­bia, Pana­ma, Do­mini­can Re­pub­lic and Nicaragua) and Asia (Philip­pines, Thai­land and Sri Lan­ka).

“We ex­pect key sec­ondary end­point da­ta from the TIDES tri­al in lat­er this year, in­clud­ing safe­ty, ef­fi­ca­cy against hos­pi­tal­iza­tion, and analy­ses of ef­fi­ca­cy by base­line serosta­tus, serotype, and sever­i­ty,” Wal­lace wrote in an email.

Vac­cines was one of four key ar­eas (along­side can­cer, GI and CNS dis­eases) that CEO Christophe We­ber pre­scribed for Take­da in an ef­fort to trans­form the Japan­ese drug­mak­er in­to a glob­al play­er — be­fore vault­ing to the top 10 list via the ac­qui­si­tion of rare dis­ease gi­ant Shire. It re­mains one of three “glob­al busi­ness units,” Wal­lace said, along with on­col­o­gy and plas­ma-de­rived ther­a­pies.

“Take­da fo­cus­es its R&D ef­forts on four ther­a­peu­tic ar­eas: On­col­o­gy, Gas­troen­terol­o­gy (GI), Neu­ro­science and Rare Dis­eases, while we al­so make tar­get­ed R&D in­vest­ments in Plas­ma-De­rived Ther­a­pies and Vac­cines,” he wrote.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.