UK an­titrust watch­dog clears Roche/Spark deal — but what is the FTC think­ing?

Roche has gained the bless­ing from the UK an­titrust watch­dog to pro­ceed with its $4.3 bil­lion ac­qui­si­tion of Spark, just in time for the lat­est dead­line the phar­ma gi­ant has set for Spark’s in­vestors to ten­der their shares fol­low­ing 10 de­lays.

The Com­pe­ti­tion and Mar­kets Au­thor­i­ty con­firmed spec­u­la­tion and ru­mors — pret­ty much as­sumed true at this point — that they had been look­ing in­to the com­pet­i­tive land­scape for he­mo­phil­ia A treat­ments. Af­ter con­clud­ing that there will still be an ad­e­quate choice of al­ter­na­tives even af­ter the mak­ers of Hem­li­bra and a po­ten­tial gene ther­a­py are blend­ed in­to one, reg­u­la­tors gave the deal an un­con­di­tion­al clear­ance.

The CMA added that it’s co­op­er­at­ed close­ly with the US Fed­er­al Trade Com­mis­sion, which is still in­ves­ti­gat­ing the buy­out.

By wrap­ping their in­ves­ti­ga­tion at Phase I, the British au­thor­i­ty saved Roche some un­cer­tain­ty and lengthy de­lays that would have en­sued if they had ini­ti­at­ed a Phase II, an ex­tend­ed and scru­ti­niz­ing re­view that can last up to 24 weeks.

From their re­lease:

While gene ther­a­py treat­ments are like­ly to com­pete with Roche’s Hem­li­bra in fu­ture, the CMA found that Spark is not the on­ly sup­pli­er de­vel­op­ing a gene ther­a­py treat­ment and that its prod­ucts are not cur­rent­ly con­sid­ered to hold any par­tic­u­lar clin­i­cal or com­mer­cial ad­van­tages over those be­ing de­vel­oped by oth­er sup­pli­ers.

The CMA’s in­ves­ti­ga­tion al­so found that there are sev­er­al in­no­v­a­tive non-gene ther­a­py prod­ucts un­der de­vel­op­ment that are like­ly to be­come vi­able al­ter­na­tives to Roche and Spark’s treat­ments.

With the of­fer­ing pe­ri­od set to ex­pire by the end of the day, Roche has yet to an­nounce ei­ther an­oth­er de­lay or how it plans to close the deal in such a short time frame. In fact, the Swiss drug­mak­er raised some eye­brows last Mon­day when it ex­tend­ed the dead­line by a mere six days, com­pared to the usu­al one month.

It ap­pears that the FTC re­view re­mains the fi­nal hur­dle ahead of a close. In Oc­to­ber the Capi­tol Fo­rum re­port­ed that the agency’s staff had rec­om­mend­ed the deal from ap­proval, but a spokesper­son lat­er fol­lowed up to End­points News with a clar­i­fi­ca­tion: “The FTC has not filed a com­plaint in this mat­ter, and the agency doesn’t sign off on deals. It ei­ther files a com­plaint or it doesn’t.”

Ear­li­er this year, the FTC re­quest­ed a rare “sec­ond re­quest” — some­thing slapped on on­ly 5% of ac­qui­si­tions. A vote from the chair­man and four com­mis­sion­ers on its Bu­reau of Com­pe­ti­tion would mark the fi­nal step for ap­proval.

Gbo­la Amusa

As the saga un­fold­ed, ob­servers have voiced con­cerns that the holdup would have a chill­ing ef­fect on gene ther­a­py M&A and scare would-be ac­quir­ers away. But Chardan an­a­lyst Gbo­la Amusa, who cov­ers oth­er gene ther­a­py play­ers such as Bio­Marin and uniQure, won­ders if it has more to do with buy­er’s re­morse on Roche’s end.

“It was one that nev­er made sense to us at that val­u­a­tion giv­en our view, and I don’t know why it hasn’t gone through,” he said, “but I don’t think there’s any read-across for the rest of the space.”

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.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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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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James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.

En­do pays $658M in a fur­ther bet on col­la­gen-based med­i­cines, buy­ing out long­time bio­phar­ma part­ner

A little less than two years after Endo Pharmaceuticals’ deal to purchase Somerset Therapeutics fell through, the Irish drugmaker is returning to the well with a much bigger acquisition.

Endo has agreed to buy BioSpecifics Technologies for a whopping $658 million, the two companies announced Monday, in the culmination of a research agreement signed all the way back in 2004. Endo will purchase all of BioSpecifics’ outstanding stock for about $540 million, valuing the company at $88.50 per share — a 45% premium on the $61.02 share price at which the company closed on Friday.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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CAR-plus: Irish biotech re­cruits Kite alum Chris Now­ers to prep dual-tar­get­ing NK cell ther­a­py for the clin­ic

Soon after Chris Nowers left Cell Medica — freshly rebranded Kuur Therapeutics — in February, the Kite Pharma alum was introduced to another cell therapy player.

The basic idea of building an off-the-shelf allogeneic platform with a CAR-NK approach was familiar to him, riding on the same wave as Takeda, J&J-backed Fate, Nkarta and others. But then there was something else that stood out: a membrane-bound TNF related apoptosis inducing ligand variant, or TRAIL variant, that’s also engineered onto the NK cell for a dual-targeted attack.

IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.