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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Derek Chalmers, Cara Therapeutics CEO

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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