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
Revance feels like it has a competitive advantage over AbbVie’s blockbuster Botox with only biannual injections of its freshly approved Daxxify, as opposed to the injections every three or four months that Botox requires. But you come at the king, you best not miss, and to bolster the executive team, Revance has now tapped David Hollander as CMO. Hollander was previously the chief R&D officer at Aerie Pharmaceuticals, which was sold to Alcon a couple months ago in a $770 million deal, and he has familiarity with the Botox developer through his 10 years at Allergan. From 2011-16, he was Allergan’s VP, global therapeutic area head in clinical development for anterior segment and consumer eye care.
After two Florida-based CRO study coordinators pled guilty to falsifying clinical trial data, the DOJ said Wednesday that those two have been sentenced to more than two years in prison each.
Federal judge Donald Graham sentenced Analay Rico, lead study coordinator at Tellus Clinical Research, to 40 months in prison, and Daylen Diaz, assistant study coordinator and research assistant at Tellus, to 24 months in prison, along with $2.1 million in fines related to their conspiracy to commit fraud.
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.
Cap-binding proteins that bind to one end of RNA sequences direct how they are spliced and translated into proteins. In particular, the protein eIF4E binds to mRNA caps and guides translation (the eIF stands for eukaryotic translation initiation factor).
Unlock this story instantly and join 151,700+ biopharma pros reading Endpoints daily — and it’s free.
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.
Drug pricing watchdog ICER on Thursday released its final report on drug price increases in California that were unsupported by new clinical evidence, pointing to three outliers — Bristol Myers Squibb’s cancer drugs Revlimid and Sprycel, and Eli Lilly’s migraine drug Emgality.
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.
The Medicines Patent Pool on Thursday unveiled a new voluntary licensing agreement with Novartis to increase access to its patented, second-line chronic myeloid leukemia drug Tasigna (nilotinib) in certain lower-income countries.
The drug, which is on the WHO’s list of essential medicines, will now be made by select generic manufacturers and offered in seven middle-income countries — Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines and Tunisia — where patents on the product are pending or in force.
Unlock this story instantly and join 151,700+ biopharma pros reading Endpoints daily — and it’s free.
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.
Unlock this story instantly and join 151,700+ biopharma pros reading Endpoints daily — and it’s free.
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.
Unlock this story instantly and join 151,700+ biopharma pros reading Endpoints daily — and it’s free.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
© Endpoints Company 2022
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET

source

Add a Comment

Your email address will not be published. Required fields are marked *