Un­der new lead­er­ship, No­var­tis' San­doz unit breaks up with dig­i­tal ther­a­peu­tics out­fit Pear

Looks like No­var­tis’ San­doz unit — un­der new lead­er­ship — has sev­ered ties with Pear Ther­a­peu­tics, dis­solv­ing the part­ner­ship that was inked in 2018.

Last year, San­doz and Pear col­lab­o­rat­ed on and launched re­SET, an FDA-ap­proved dig­i­tal ther­a­peu­tic de­signed to de­liv­er cog­ni­tive be­hav­ioral ther­a­py over 12 weeks to pa­tients with sub­stance abuse dis­or­der (SUD) who are in out­pa­tient treat­ment un­der the su­per­vi­sion of a doc­tor. The Swiss drug­mak­er al­so in­vest­ed in Pear’s Se­ries B round of fi­nanc­ing an­nounced in Jan­u­ary 2018.

The fu­ture of No­var­tis’ gener­ics unit San­doz is un­cer­tain — as price ero­sion in the Unit­ed States fu­els spec­u­la­tion that No­var­tis chief Vas Narasimhan might pre­fer to spin it off to sharp­en fo­cus on de­vel­op­ing new treat­ments.

Richard Saynor No­var­tis

In March, San­doz CEO Richard Fran­cis abrupt­ly ten­dered his res­ig­na­tion, sug­gest­ing he couldn’t com­mit to the ‘mul­ti-year’ trans­for­ma­tion that San­doz was em­bark­ing on. Fran­cis was re­placed by Richard Saynor, SVP clas­sic & es­tab­lished prod­ucts, com­mer­cial & dig­i­tal plat­forms at GSK — al­though he was with San­doz pri­or to that stint.

The “de­ci­sion to tran­si­tion com­mer­cial­iza­tion re­spon­si­bil­i­ties for re­SET and re­SET-O is part of San­doz trans­for­ma­tion and sub­se­quent lead­er­ship change, which has re­sult­ed in a re­in­forced fo­cus on and cap­i­tal al­lo­ca­tion for San­doz core busi­ness,” the com­pa­ny said in a state­ment on Tues­day.

Pre­scrip­tion dig­i­tal ther­a­peu­tics — such as re­SET and Abil­i­fy Mycite, the first dig­i­tal pill that car­ries an em­bed­ded sen­sor to track if pa­tients are tak­ing their med­ica­tion prop­er­ly — are val­i­dat­ed in ran­dom­ized clin­i­cal tri­als to demon­strate safe­ty and ef­fi­ca­cy.

The FDA ap­proved re­SET in 2017, on the ba­sis of a NI­DA-spon­sored tri­al in­volv­ing 399 pa­tients with SUD. Pa­tients were ran­dom­ized to re­ceive stan­dard treat­ment — com­pris­ing in­ten­sive face-to-face coun­sel­ing — or re­duced amount of face-to-face coun­sel­ing plus the dig­i­tal ther­a­peu­tic. Pa­tients on the dig­i­tal ther­a­peu­tic more than dou­bled the rate of ab­sti­nence com­pared to stan­dard face-to-face coun­sel­ing. Pear Ther­a­peu­tics is al­so de­vel­op­ing dig­i­tal ther­a­peu­tics for a host of oth­er dis­or­ders in­clud­ing schiz­o­phre­nia, PTSD and gen­er­al anx­i­ety dis­or­der. In De­cem­ber 2018, the FDA ap­proved re­SET-O, for the opi­oid use dis­or­der.

Dig­i­tal ther­a­peu­tics is an um­brel­la term that in­cludes tech­nol­o­gy such as wear­able de­vices, mo­bile apps and telemed­i­cine plat­forms — which is typ­i­cal­ly dri­ven by soft­ware to pre­vent, man­age, or treat dis­or­ders, in­de­pen­dent­ly or in con­cert with med­ica­tion and/or med­ical de­vices. These tools are large­ly de­signed to ad­dress chron­ic dis­eases such as di­a­betes, heart or res­pi­ra­to­ry dis­or­ders, by tar­get­ing be­hav­iors such as di­et, ex­er­cise, and lifestyle that have a sig­nif­i­cant im­pact on the in­ci­dence and man­age­ment of dis­ease.

Al­though the rapid pen­e­tra­tion of smart­phones and tablets and low­er health­care costs have dri­ven the growth of the glob­al dig­i­tal ther­a­peu­tics mar­ket, pri­va­cy con­cerns could tem­per the pace of adop­tion. Still, the size of the glob­al dig­i­tal ther­a­peu­tics mar­ket is ex­pect­ed to hit about $7.83 bil­lion by 2025, from $1.75 bil­lion in 2017 — ac­cord­ing to Al­lied Mar­ket Re­search es­ti­mates.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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