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.

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.

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.