The top 15 would-be block­busters in the pipeline prep­ping for a 2017 launch

This is the year that a whole slate of Big Phar­mas should be able to score brag­ging rights to block­buster drug launch­es. And af­ter last year’s pal­try roundup of new drug ap­provals, they all des­per­ate­ly need it.

Every year EP Van­tage likes to do its break­down of the top 20 small mol­e­cules and bi­o­log­ics aim­ing to hit the mar­ket, ranked by es­ti­mat­ed sales po­ten­tial 5 years down the road. (Be­ing a bit ag­nos­tic about this, we mashed the two lists in­to one and ranked them all by peak sales fore­casts.)

There are 15 would-be block­busters in Eval­u­atePhar­ma’s top 20. And this year’s list in­cludes some no­table stand­outs.

As­traZeneca has one drug on the list, its PD-L1 check­point in­hibitor dur­val­um­ab, which is make or break for this phar­ma gi­ant. The di­ver­si­fied J&J, which has three drugs on the block­buster list, is look­ing to cap­i­tal­ize on some ear­li­er deal­mak­ing. Eli Lil­ly still has a point to make with baric­i­tinib, hop­ing to show that it can con­sis­tent­ly de­vel­op new block­busters. Sanofi and Re­gen­eron have some scores to set­tle with dupilum­ab. And Roche is back with a po­ten­tial megablock­buster to add — af­ter a de­lay of game near the end of last year.

You’ll even find Glax­o­SmithK­line on the list with sirukum­ab, which you’ll find near the bot­tom, part­nered with J&J. To be sure, Shin­grix is al­so like­ly to come close to block­buster sta­tus, giv­ing the com­pa­ny more to be pleased with from its vac­cines di­vi­sion. But the com­pa­ny man­ages to con­sis­tent­ly dis­ap­point an­a­lysts with an un­ex­cit­ing late-stage pipeline.

A cou­ple of biotechs make the grade. Tesaro is up top with ni­ra­parib (where it will weigh in against a striv­ing As­traZeneca). And Kite is out to score the biggest new en­try among the pi­o­neer­ing CAR-Ts. Both will be look­ing to make a big change in grow­ing com­mer­cial­iza­tion arms.

Here’s a snap­shot of the 15 new drugs launch­ing this year that can rea­son­ably ex­pect to hit block­buster sta­tus in 2022. Just re­mem­ber, peak sales es­ti­mates are con­sis­tent­ly dis­ap­point­ing. Sell-side an­a­lysts of­ten over­look just how hard pay­ers can fight against new en­tries with big prices. And right now, who re­al­ly knows what the Trump ad­min­is­tra­tion has in mind for keep­ing its promise to slash drug prices?


Dupilum­ab — $4.6 bil­lion

Dupix­ent fits the bill for a mon­ster ther­a­py. An­oth­er big drug from the team of Sanofi and Re­gen­eron, this one fo­cused on atopic der­mati­tis — eczema to you and me. This is the first mon­o­clon­al an­ti­body that blocks both Il-4 and IL-13 cy­tokines, and there’s noth­ing that looks like a ri­val threat on the near hori­zon, leav­ing these two big play­ers a lot of room to move. Chance of ap­proval: High.

Ocre­lizum­ab — $4.0 bil­lion

Roche’s Ocre­vus was sup­posed to be on the list of 2016 block­busters, but man­u­fac­tur­ing is­sues — sound fa­mil­iar? — got in the way late last year, shov­ing back a prospec­tive ap­proval for this MS block­buster in­to 2017. Chances of ap­proval: High.

Dur­val­um­ab — $2.3 bil­lion

By it­self, the PD-L1 check­point in­hibitor dur­val­um­ab from As­traZeneca will have a hard time liv­ing up to the big fu­ture that the phar­ma gi­ant now re­quires. That’s why AZ switched gears to com­bine it with treme­li­mum­ab for first-line lung can­cer. And if it’s ap­proved, you can be sure that As­traZeneca’s sales team will push it as hard as they can. CEO Pas­cal So­ri­ot has his back up against a rock now, with rev­enue still slid­ing. Fail­ure is not an op­tion, but it’s a re­al threat — even if this drug sim­ply doesn’t live up to some big ex­pec­ta­tions.

Semaglu­tide — $2.0 bil­lion

The big news from No­vo Nordisk’s key Phase III study was that their week­ly GLP-1 can­di­date sig­nif­i­cant­ly cut the risk of car­dio events. The bad news: It just might blind you. Add it all up, though, and you have a da­ta set that No­vo will take to reg­u­la­tors with high ex­pec­ta­tions of an ap­proval, and a strong po­si­tion to pro­tect its big GLP-1 po­si­tion in the huge di­a­betes mar­ket. Big, though, doesn’t mean ex­pand­ing. No­vo and its ri­vals are strug­gling to main­tain a grip on the di­a­betes mar­ket, and they’re los­ing. New en­tries like this are key to their fu­tures.

Ni­ra­parib — $1.8 bil­lion

Tesaro has big plans for its PARP in­hibitor ni­ra­parib. Un­der a speedy re­view at the FDA, the biotech has been ea­ger to get out in­to the mar­ket and take on As­traZeneca’s Lyn­parza. Lyn­parza, though, may soon have a bet­ter pro­file than it ac­quired when the agency gave it an ac­cel­er­at­ed ap­proval. And oth­er PARPs, fo­cused on dif­fer­ent pa­tient pop­u­la­tions, will be crowd­ing in in search of dif­fer­ent ap­provals to ex­pand their use. Clo­vis is out with ru­ca­parib al­ready, look for Pfiz­er to fol­low with ta­la­zoparib.

Baric­i­tinib — $1.8 bil­lion

Eli Lil­ly in­tend­ed to mar­ket this rheuma­toid arthri­tis drug as Olu­mi­ant, and it has pur­sued a wide rang­ing clin­i­cal pro­gram to gath­er proof that it’s ef­fec­tive over a lengthy pe­ri­od of time, with im­proved per­for­mance over Hu­mi­ra. So far so good for Lil­ly, which isn’t ex­pect­ed to face much re­sis­tance from reg­u­la­tors. But Lil­ly tends to grav­i­tate to com­pet­i­tive fields, and it will have to fight some bat­tles to carve mar­ket share.

Ri­bo­ci­clib — $1.5 bil­lion

In the fi­nal stretch in its jour­ney to reg­u­la­tors, No­var­tis post­ed a pos­i­tive snap­shot of piv­otal Phase III da­ta on its CDK 4/6 con­tender ri­bo­ci­clib (LEE011), set­ting up a like­ly show­down with Pfiz­er in treat­ing breast can­cer. The head­line fig­ure from ES­MO was that ri­bo­ci­clib com­bined with letro­zole re­duced the risk of death or pro­gres­sion by 44% among first-line pa­tients com­pared to letro­zole alone, of­fer­ing fur­ther en­cour­age­ment to the phar­ma gi­ant that it’s right on track to gain­ing an ap­proval for this drug this year.

Spin­raza — $1.46 bil­lion

Bio­gen won an ap­proval for this spinal mus­cu­lar at­ro­phy drug re­cent­ly, then man­aged to sur­prise a lot of an­a­lysts with a stick­er price that starts at $750,000 for the first year. That may not have earned much at­ten­tion in the past, but with the spot­light on drug prices, more than a few thought that the biotech com­pa­ny could find it­self in the cross hairs of @re­al­Don­aldTrump. That hasn’t hap­pened, yet.

Apa­lu­tamide (ARN-509) — $1.45 bil­lion

Here’s a drug that you may not re­mem­ber. J&J struck one of its clas­sic $1 bil­lion deals for this drug, in­clud­ing $650 mil­lion up­front, when it bought Aragon from Rich Hey­man and his team back in 2013. J&J kept it qui­et, but it hus­tled along with plans to push through late-stage de­vel­op­ment AS­AP with this next-gen an­ti-an­dro­gen drug for prostate can­cer. And now here they are, four years lat­er with a would-be block­buster on their hands. And don’t you think oth­er com­pa­nies re­gret not mak­ing a few of these bil­lion-dol­lar bets as well?

KTE-C19 — $1.41 bil­lion

Kite Phar­ma­ceu­ti­cals may or may not be the first com­pa­ny to win an ap­proval for a CAR-T. No­var­tis could beat them to the punch, with both ex­pect­ing to com­plete ap­pli­ca­tions in ear­ly 2017. And there are a few naysay­ers who re­main deeply skep­ti­cal, de­mand­ing to see more than 3-month re­sults on pa­tients. But Eval­u­ate gives Kite the edge on hit­ting block­buster sta­tus first with a drug that reengi­neers pa­tients’ T cells in­to a can­cer drug. This would be Kite’s first mar­ket­ed ther­a­py, and they’re mov­ing at a rapid pace.

Ner­a­tinib — $1.25 bil­lion

While some an­a­lysts have been deeply skep­ti­cal about this drug’s prospects due to its well es­tab­lished link to se­vere di­ar­rhea, Puma’s team has been push­ing this one along for breast can­cer at a steady pace. The bear po­si­tion on Puma is that the drug could be too tox­ic even for the FDA, which has proven will­ing to put up with sig­nif­i­cant threats for drugs ini­tial­ly aimed at dy­ing pa­tients. Bulls be­lieve that the safe­ty bar is low enough to clear.

Guselkum­ab — $1.2 bil­lion

J&J hasn’t been the least bit shy about tout­ing the pos­i­tive late-stage da­ta that it has ac­crued for pso­ri­a­sis. J&J’s sec­ond drug on the top 15 will set out to in­crease its pres­ence in a mar­ket where it’s been build­ing sales for Ste­lara while main­tain­ing an old main­stay, Rem­i­cade, an an­ti-TNF drug like Hu­mi­ra. This new drug is slat­ed to ar­rive as biosim­i­lars for both of the old drugs are an­gling to hit the mar­ket, though Ab­b­Vie has vowed to fight to the bit­ter end over Hu­mi­ra’s patent pro­tec­tion. J&J, though, be­lieves it has the bet­ter drug, which was in-li­censed from Mor­phoSys.

Eu­crisa (crisabo­role) — $1.15 bil­lion

Pfiz­er won the FDA ap­proval for eczema late in 2016, putting it on track for a launch in ear­ly 2017. Pfiz­er snapped up the non-steroidal top­i­cal PDE4 in­hibitor with an­ti-in­flam­ma­to­ry prop­er­ties last May when it ac­quired Ana­cor Phar­ma­ceu­ti­cals for $5.2 bil­lion. The drug came through back in mid-2015 in a pair of stud­ies which en­rolled more than 1,500 pa­tients, beat­ing out a place­bo and post­ing an ac­cept­able safe­ty pro­file. Once dupilum­ab hits the mar­ket, though, Pfiz­er will be up against some heavy­weight com­pe­ti­tion.

Sirukum­ab — $1.13 bil­lion

J&J has re­peat­ed­ly tapped sirukum­ab as a key part of its Phase III ef­fort to line up ma­jor new prod­ucts for the mar­ket­ing group. GSK, mean­while, has been try­ing to over­come per­sis­tent crit­i­cism that its pipeline lacks piz­zazz. In their deal on sirukum­ab, GSK gained com­mer­cial rights in the US and the West­ern Hemi­sphere, while J&J lined up Eu­rope and the rest of the world. Mixed da­ta in a head-to-head with Hu­mi­ra, though, will make some an­a­lysts won­der how this drug will fair in a mar­ket fight.

SD-809 (deutetra­benazine) — $1 bil­lion

Te­va made the list, just bare­ly. The FDA re­ject­ed SD-809 for Hunt­ing­ton’s dis­ease (it’s been re­sub­mit­ted), but came back with pos­i­tive da­ta on tar­dive dysk­i­ne­sia. A year-and-a-half ago Te­va $TE­VA splurged on a $3.5 bil­lion ac­qui­si­tion of Aus­pex, bag­ging the new and what it hoped was an im­proved drug for Hunt­ing­ton’s. Now it’s say­ing that its sec­ond late-stage study shows that the drug is clear­ly a suc­cess, but there are still some sig­nif­i­cant prob­lems to ad­dress. An ap­proval is like­ly to set up a head-to-head com­pe­ti­tion with Neu­ro­crine, which might have the bet­ter drug.