Takeda adds one more late-stage treatment to its growing roster of celiac drugs – Endpoints News

What­ev­er hap­pens with Take­da’s de­ter­mined cam­paign to tack­le celi­ac dis­ease from all sides, no one will ever be able to fault them for a lack of ded­i­ca­tion to the cause.
This morn­ing, the glob­al play­er joined hands with Zedi­ra and Dr. Falk Phar­ma GmbH on a Phase IIb celi­ac drug dubbed ZED1227/TAK-227, giv­ing Take­da dibs on the big US mar­ket plus a string of coun­tries out­side Eu­rope.
Take­da, though, is any­thing but a new­com­er when it comes to fight­ing gluten in­tol­er­ance, a food al­ler­gy that cur­rent­ly can on­ly be treat­ed with a strict di­et that avoids all wheat, bar­ley and rye. The com­pa­ny has inked a range of al­liances to build up a pipeline of a well-ad­vanced set of drugs for celi­ac.
While tol­er­ance can vary wide­ly, the most acute­ly af­flict­ed can ex­pe­ri­ence painful ef­fects af­ter con­sum­ing on­ly trace amounts of gluten. And that can all lead to some se­ri­ous chron­ic ail­ments.
This par­tic­u­lar drug came out of Darm­stadt-based Zedi­ra, which bills ZED1227 as “the first di­rect-act­ing trans­g­lu­t­a­m­i­nase in­hibitor in clin­i­cal de­vel­op­ment.”
Writ­ing in the NE­JM, re­searchers had celi­ac pa­tients with a range of sever­i­ties eat 3 mg of gluten in a bis­cuit dai­ly for 6 weeks. And they con­clud­ed in the PoC study that all three dos­es were linked with low­er mu­cos­al dam­age typ­i­cal of celi­ac.
The crew at Take­da has lined up mul­ti­ple shots on its goal to treat celi­ac for the first time. In ear­ly 2020, they bought out lit­tle PvP Bi­o­log­ics in a $330 mil­lion-plus deal cov­er­ing mile­stones and an up­front. That drug, TAK-062, is a pro­tein de­signed to de­grade gluten. Then there’s TAK-101: “a po­ten­tial first-in-class, im­mune-mod­i­fy­ing nanopar­ti­cle con­tain­ing gliadin pro­teins de­signed to pro­mote im­mune tol­er­ance to gluten in celi­ac dis­ease by pre­vent­ing gliadin-spe­cif­ic T-cell ac­ti­va­tion.”
Key takeaways:
The data supporting regulatory approval alone are often insufficient for demonstrating the added benefit of a new therapy
Planning in advance to continuously deliver data that illustrate value and post-launch, to not only the regulator, but payers, healthcare professionals, and patients results in more clinically meaningful benefits
By working cross-functionally, biopharmaceutical teams can uncover evidence gaps and better shape registration trials to ensure the needs of as many stakeholders as possible are met
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In Ratatouille, Remy the rat controls a young cook from his chef’s hat, directing his every move in the restaurant kitchen and helping him make food. Well, messenger RNAs have a Remy too.
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Back in 2017, Takeda shelled out more than $5 billion for a smaller company called Ariad Pharmaceuticals, its leukemia drug Iclusig (ponatinib) and its ALK-inhibiting lung cancer drug Alunbrig (brigatinib).
Fast forward five years, and while Iclusig continues to pull in more than $200 million per year for Takeda, the company is now looking to fend off generic competitors, filing suit in New Jersey federal court earlier this week to block a competitor, Canada-based Apotex.
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The report builds on a price transparency law passed in California in 2017, which requires manufacturers to report year-over-year spending increases to prescription drugs’ WAC prices, but does not include net prices, which ICER took issue with.
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Behind Amgen and Mirati are a whole host of players lining up their own KRAS candidates.
Roche is no exception. The Big Pharma already has its own in-house KRAS drug from its subsidiary Genentech that is currently in Phase I studies, but is now expanding its options.
Roche has licensed a preclinical KRAS program from Hookipa Pharma for $25 million upfront, Hookipa announced Thursday morning. Roche also has the option of adding a second immunotherapy candidate for $15 million.
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Less than 2 years after some Oxford grads pieced together a little £6 million seed fund to launch their discovery outfit, the antibody developer has been scooped up by one of the pharma giants scouting the bargain aisle of early-stage drug development.
And the founders did considerably better than the seed round might suggest.
AbbVie is swooping in for the buyout with $255 million in cash for DJS Antibodies, plus some unspecified milestones that could range quite high, given the preclinical nature of the GPCR work involved.
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The University of Kansas
Lawrence, Kansas
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