The first FDA-ap­proved dig­i­tal pill — what it means for phar­ma

By Har­sha Madan­navar, Man­ag­ing Di­rec­tor at L.E.K. Con­sult­ing

Last year, the U.S. Food and Drug Ad­min­is­tra­tion (FDA) ap­proved what is per­haps the bold­est use of dig­i­tal tech­nol­o­gy in health­care: a pill that is in­te­grat­ed with an in­gestible sen­sor that cap­tures in­for­ma­tion about whether the pa­tient has com­plied with her med­ica­tion reg­i­men. A pa­tient in­gests the pill and it sends the da­ta to a patch worn on her tor­so, which adds var­i­ous phys­i­o­log­ic mea­sures. From there the in­for­ma­tion is wire­less­ly sent to a mo­bile phone app, al­low­ing both the pa­tient and her physi­cian to track how the pa­tient is us­ing and re­spond­ing to her med­ica­tion.

L.E.K. Con­sult­ing be­lieves that the FDA’s ap­proval of Japan-based Ot­su­ka Phar­ma­ceu­ti­cal’s Abil­i­fy MyCite for cer­tain psy­chi­atric con­di­tions — a first for dig­i­tal med­i­cine — will be seen as a land­mark in pa­tient-cen­tered care. Ap­prox­i­mate­ly 50% of pa­tients do not ad­here to their med­ica­tion as pre­scribed, tak­ing it spo­rad­i­cal­ly or with con­traindi­cat­ed foods or med­i­cines, and 20-30% of pre­scribed med­ica­tions are nev­er even picked up at a phar­ma­cy. This non­ad­her­ence prob­lem varies in acu­ity de­pend­ing on the dis­ease and the pop­u­la­tion that is af­fect­ed. The cost of this waste runs in­to the bil­lions of dol­lars in un­used med­ica­tion and, in ad­di­tion, of­ten more ex­pen­sive med­ical care.

Bridg­ing gaps in glob­al health­care

The ben­e­fits of dig­i­tal med­i­cine go be­yond the sav­ing of costs to the health­care sys­tem. Over time, we be­lieve that it can help solve three core prob­lems — we call them gaps — be­dev­il­ing the de­vel­op­ment and the de­liv­ery of health­care around the world.

Out­comes. For starters, dig­i­tal med­i­cine can bridge the out­comes gap. When physi­cians can track their pa­tients’ com­pli­ance with a pre­scribed med­ica­tion, and how pa­tients are re­spond­ing to it, they can man­age their care bet­ter. The re­sult is su­pe­ri­or health out­comes.

Physi­cians ben­e­fit by be­ing able to track their pa­tients based on ac­cu­rate, con­tin­u­ous da­ta — their heart­beat and tem­per­a­ture, whether they’re sleep­ing or walk­ing, and whether they’ve tak­en the right med­ica­tion at the right time. And pa­tients are em­pow­ered with that same da­ta to be­come more en­gaged in their over­all health. Health out­comes are most like­ly to be im­proved when health pro­fes­sion­als and pa­tients work in con­cert.

Ac­cess. In many parts of the world, in de­vel­oped coun­tries and par­tic­u­lar­ly in de­vel­op­ing coun­tries, many pa­tients live far from a mod­ern physi­cian prac­tice or a large med­ical cen­ter. Dig­i­tal med­i­cine, by en­abling the re­mote mon­i­tor­ing of a pa­tient’s med­ical ad­her­ence cou­pled with phys­i­o­log­i­cal da­ta, can alert a physi­cian to events that may re­quire in­ter­ven­tion, such as a skipped dose or an alarm­ing side ef­fect. This dra­mat­ic im­prove­ment in a pa­tient’s re­mote ac­cess to a health­care pro­fes­sion­al holds the po­ten­tial for up­grad­ing the speed and ac­cu­ra­cy of med­ical de­ci­sion-mak­ing.

Pro­teus Dig­i­tal Health (which li­censed the en­abling dig­i­tal pill tech­nol­o­gy to Ot­su­ka) has been work­ing to bring its plat­form to Chi­na. The fol­low­ing fac­tors about Chi­na make the coun­try ripe for dig­i­tal med­i­cine: A ma­jor­i­ty of the pop­u­la­tion us­es the mo­bile mes­sag­ing plat­form WeChat, and the ca­pac­i­ty of health­care ser­vices in both ur­ban and rur­al ar­eas is in­suf­fi­cient.

In­no­va­tion. Dig­i­tal med­i­cine may al­so play a role in en­sur­ing the sus­tain­abil­i­ty of in­no­va­tion. First, there is the sheer nov­el­ty of the tech­nol­o­gy: a pill joined with an FDA-ap­proved in­gestible sen­sor made of sil­i­con, mag­ne­sium and cop­per that cap­tures crit­i­cal da­ta about whether we’re com­ply­ing with our med­ica­tions. Sec­ond, it se­cure­ly and wire­less­ly sends this da­ta to a wear­able patch on the pa­tient’s side that adds phys­i­o­log­ic mea­sures and trans­mits the com­bined in­for­ma­tion to a physi­cian via the cloud.

Key chal­lenge fac­ing dig­i­tal adop­tion

The abil­i­ty of dig­i­tal med­i­cine to bridge all the above gaps and be­come a glob­al stan­dard pre­sup­pos­es that doc­tors have adopt­ed it, reg­u­la­tors are com­fort­able with it, pa­tients are de­mand­ing it and pay­ers are cov­er­ing it.

A key chal­lenge is that there is a de­gree of skep­ti­cism among phar­ma­ceu­ti­cal com­pa­nies and some physi­cians. Phar­ma­ceu­ti­cal com­pa­nies, like oth­er large or­ga­ni­za­tions, can be no­to­ri­ous­ly slow to in­te­grate in­no­v­a­tive tech­nolo­gies or plat­forms. Physi­cians, par­tic­u­lar­ly those in large hos­pi­tal sys­tems, have bare­ly enough face time with pa­tients and even less time to adapt to new care de­liv­ery mod­els or new de­ci­sion-mak­ing par­a­digms. Many of them will take a wait-and-see at­ti­tude to­ward dig­i­tal med­i­cine. A few ear­ly ap­pli­ca­tions like Ot­su­ka’s Abil­i­fy MyCite will raise aware­ness of the tech­nol­o­gy and speed its ac­cep­tance in the mar­ket.

Glob­al phar­ma’s con­tin­ued evo­lu­tion

One thing is for sure — we are en­ter­ing a brave new world of pa­tient-cen­tered dig­i­tal health. We be­lieve that dig­i­tal med­i­cines will play an im­por­tant role in the evo­lu­tion of glob­al phar­ma, from to­day’s in­dus­try that sells prod­ucts and en­ables doc­tors to pre­scribe med­ica­tions to to­mor­row’s in­dus­try that of­fers ser­vic­ing so­lu­tions and en­ables con­sumers to reach health out­comes in part­ner­ship with their care team.

Down­load the full ar­ti­cle on the L.E.K. Con­sult­ing web­site.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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