Christophe Weber, Takeda president and CEO (AP Images)

Take­da gets a $2.2B deal for its OTC unit as debt-re­lief dri­ve nears its end

In a big step to­ward its $10 bil­lion di­vest­ment goal, Take­da struck a deal to sell its Japan­ese con­sumer health­care busi­ness, known for over-the-counter prod­ucts, to US pri­vate eq­ui­ty firm Black­stone Group.

Take­da Con­sumer Health­care Com­pa­ny was priced at around ¥242 bil­lion ($2.28 bil­lion), though that val­ue will be ad­just­ed to ac­count for net debt and work­ing cap­i­tal, ac­cord­ing to Take­da.

The deal — ex­pect­ed to close by the end of March 2021 —is part of Take­da’s plan to shed $10 bil­lion in non-core as­sets to bal­ance out debt in­curred in the com­pa­ny’s $62 bil­lion Shire ac­qui­si­tion. The buy­out made Take­da a top 10 in­ter­na­tion­al drug com­pa­ny, but al­so sad­dled it with a re­port­ed $48 bil­lion in net debt. Fol­low­ing the ac­qui­si­tion, Take­da shift­ed its fo­cus to the fol­low­ing five ar­eas: gas­troen­terol­o­gy (GI), rare dis­eases, plas­ma-de­rived ther­a­pies, on­col­o­gy and neu­ro­science.

Black­stone will gain a port­fo­lio of OTC drugs and prod­ucts which raked in a to­tal rev­enue of ¥60 bil­lion ($567 mil­lion) last year, in­clud­ing Ali­namin, TCHC’s top-sell­ing prod­uct.

This is Take­da’s fourth deal this year to sell off non-core as­sets. It al­so agreed to di­vest as­sets in Asia-Pa­cif­ic to Cell­tri­on for up to $278 mil­lion in June; to Eu­ro­pean Ori­farm for up to $670 mil­lion in April; and to Latin-Amer­i­can Hy­pera Phar­ma for $825 mil­lion in March. And less than a month ago, Take­da be­gan of­fer­ing ear­ly re­tire­ment to Japan­ese em­ploy­ees.

Last No­vem­ber, Take­da spelled out a five-year plan for 14 growth brands with 20 po­ten­tial added in­di­ca­tions, in­clud­ing budes­onide, its po­ten­tial eosinophilic esophagi­tis drug, and TAK-788, a sec­ond-line drug for non-small cell lung can­cer.

“TCHC played an im­por­tant role in Take­da’s long his­to­ry, but with our growth strat­e­gy now fo­cused on five key busi­ness ar­eas – Gas­troen­terol­o­gy (GI), Rare Dis­eases, Plas­ma-De­rived Ther­a­pies, On­col­o­gy and Neu­ro­science – and an in­creas­ing­ly com­pet­i­tive con­sumer health care mar­ket in Japan, the own­er­ship tran­si­tion will ben­e­fit both TCHC and Take­da,” Take­da pres­i­dent and CEO Christophe We­ber said in a state­ment.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,400+ biopharma pros reading Endpoints daily — and it's free.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.