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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”