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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Renhong Tang, Simcere co-CEO

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

A Chinese pharma is looking to go international with one of its preclinical candidates, and it’s teaming up with a Spanish company in a new pact potentially worth half a billion dollars to do just that.

Simcere and Almirall announced Thursday that the two companies had reached a deal for Simcere’s IL-2 mutant fusion protein drug candidate, called SIM0278. According to a statement, Almirall gets an exclusive right to develop and commercialize the drug candidate in all indications and markets outside of China, Hong Kong, Taiwan and Macau.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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