Phar­ma’s sum­mer of punk: Who's play­ing the hits — or tak­ing a hit — on the world in­no­va­tion tour

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today.

Be­fore I owned a record la­bel, I used to write a syn­di­cat­ed al­bum re­view col­umn. One of the se­ries we ran was on the ‘gold­en streaks’ – the 3 al­bum runs that have tend­ed to de­fine the peak of the ca­reers of most of the ‘clas­sic artists’, from Ste­vie Won­der to Sina­tra to Led Zep­pelin. It is pos­si­ble that we have just wit­nessed our own in­dus­try’s punk pe­ri­od – old­er artists still sell­ing well, bring­ing in the crowds, but the pow­er now be­ing in the hands of small­er, self-made artists, who may nev­er feel com­pelled to ‘sell out’.

The Phar­ma­ceu­ti­cal In­no­va­tion In­dex mea­sures, scores and cel­e­brates a com­pa­ny’s abil­i­ty to de­liv­er in­no­va­tion to pa­tients, by ob­jec­tive­ly eval­u­at­ing per­for­mance based on a rolling five year pe­ri­od (2013-2018), and op­er­ates on the sim­ple premise: if you gave the same mol­e­cule to two dif­fer­ent com­pa­nies in ear­ly phase, which would make the best of it? This year pro­vides per­haps the strongest in­di­ca­tion yet of how un­even­ly dis­trib­uted that com­pe­ten­cy (launch­ing mean­ing­ful med­i­cines) is…

Gilead has risen con­sis­tent­ly, by one place per year since 2016, to the top of the ta­ble, with an out­stand­ing an­tivi­ral per­for­mance – in 2018, Gilead de­rived 60% of its rev­enues from new drugs, more than twice any oth­er com­pa­ny, and 6 times more than the av­er­age across the top 30. It should al­so be not­ed that Gilead are the on­ly com­pa­ny con­sis­tent­ly de­liv­er­ing new drugs that hit what we’d tra­di­tion­al­ly call ‘block­buster’ sta­tus with­in 2-3 years of launch.

There is no gam­ing the Phar­ma­ceu­ti­cal In­no­va­tion In­dex – suc­cess is achieved by dis­cov­er­ing and de­vel­op­ing mean­ing­ful­ly great med­i­cines and get­ting those med­i­cines to mar­ket, and to pa­tients. What Gilead has achieved is re­mark­able – they have re­de­fined suc­cess for this in­dus­try – launch­ing tru­ly mean­ing­ful med­i­cines that swing for the bleach­ers rather than bunt, em­brac­ing nov­el­ty and orig­i­nal­i­ty over in­cre­men­tal­ism. How­ev­er, the In­dex al­so shows that suc­cess­ful in­no­va­tion is not even­ly dis­trib­uted – more than half of the top 30 com­pa­nies did not achieve an ap­proval in 2018. 2019 al­so marks the first time in the nine years of PII that J&J have not been in the Top 10, the in­verse of Gilead’s jour­ney over that same time. (To be bal­anced, Gilead haven’t yet proven that they can take an­tivi­ral skills in­to an­oth­er ther­a­peu­tic area.)

In a year that showed a record num­ber of new drug ap­provals at the FDA, it is no­table that over half were for rare dis­eases, and 39 of the 59 FDA ap­provals went to small- to mid-sized biotech (com­pa­nies out­side of the top 30), sug­gest­ing that there are sig­nif­i­cant in­no­va­tion and pro­duc­tiv­i­ty chal­lenges for large phar­ma in the com­ing years. It al­so sug­gests that, for those 39 com­pa­nies and their 39 ap­provals, the most im­por­tant next step is to prove they can suc­cess­ful­ly com­mer­cialise. As Scott Got­tlieb has hint­ed, it is not the reg­u­la­tors who are hold­ing up the in­dus­try’s in­no­va­tion – maybe it’s the ma­jor la­bels who haven’t yet learned to cope with the in­dies.

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