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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.