Take­da swoops in to buy stem cell part­ner TiGenix for $630M, putting it on the thresh­old of a like­ly ap­proval

One short step be­hind a pos­i­tive CHMP opin­ion in Eu­rope for TiGenix’s $TIG lead stem cell ther­a­py, Take­da’s mar­ket­ing em­brace has turned in­to a buy­out deal.

Take­da has struck a deal to ac­quire the Bel­gian biotech for $630 mil­lion, putting it right on the 5-yard line with Eu­ro­pean reg­u­la­tors ready to hand over an ap­proval for a new treat­ment to fight fis­tu­las among pa­tients with Crohn’s dis­ease.

Christophe We­ber

Take­da lined up a $400 mil­lion-plus mar­ket­ing pact with TiGenix on Cx601 back in 2016, drawn by an off-the-shelf stem cell ther­a­py that is now al­so in a Phase III US study de­signed to pave the way for an OK at the FDA. TiGenix re­cent­ly nar­rowed its pipeline fo­cus, high­light­ing fur­ther plans for the ear­ly-stage de­vel­op­ment of Cx611 for se­vere sep­sis among pa­tients who re­quire me­chan­i­cal ven­ti­la­tion and/or va­so­pres­sors.

Af­ter years of de­lays and dis­ap­point­ments, stem cell ther­a­pies are be­gin­ning to find their way to the mar­ket­place. And that will like­ly in­spire more such deals in the in­dus­try.

TiGenix has tout­ed 52-week re­sults for its top ther­a­py, not­ing that 56.3% of the mod­i­fied in­tent-to-treat pop­u­la­tion achieved com­bined re­mis­sion for fis­tu­las — close to the 51.5% mark seen af­ter 24 weeks. In the place­bo arm the av­er­age rates were 38.6% and 35.6%.

An­drew Plump

The buy­out comes just days ahead of the big JP­Mor­gan con­fab in San Fran­cis­co, as com­pa­nies line up deals to help at­tract at­ten­tion to their strate­gies. Take­da helped get last year’s gath­er­ing off to a noisy start with its de­ci­sion to buy Ari­ad for $5.2 bil­lion. Un­der CEO Christophe We­ber, the Japan­ese based bio­phar­ma com­pa­ny has been re­struc­tur­ing and repri­or­i­tiz­ing the pipeline, try­ing to shake off years of un­der­per­for­mance.

Chief Take­da sci­en­tist An­drew Plump is at the head of the wel­com­ing com­mit­tee. He said:

Lim­it­ed treat­ment op­tions (for the Crohn’s in­di­ca­tion) ex­ist to­day and I be­lieve we can be most ef­fec­tive in serv­ing this pop­u­la­tion by work­ing in col­lab­o­ra­tion with part­ners whose unique skill sets al­low us to more ef­fi­cient­ly ex­plore in­no­v­a­tive ap­proach­es, in­clud­ing stem cell ther­a­pies. I have had the op­por­tu­ni­ty to work along­side the TiGenix team through­out our col­lab­o­ra­tion and know that we have shared goals and var­ied, but com­ple­men­tary ex­per­tise. I am thrilled at the prospect of wel­com­ing them as part of our or­ga­ni­za­tion.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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