12 block­busters: The surg­ing list of $1B-plus drugs rolling out on the mar­ket this year might sur­prise you

What ex­act­ly qual­i­fies as a suc­cess in drug R&D may be dis­cussed and dis­put­ed in many ways, but noth­ing lays an ar­gu­ment to rest quite as de­ci­sive­ly as the re­al pos­si­bil­i­ty of block­buster sta­tus.

The da­ta an­a­lysts at Clar­i­vate An­a­lyt­ics have just as­sem­bled their an­nu­al list of all the drugs that are rolling out on­to the mar­ket this year with a sol­id shot at break­ing the one bil­lion-dol­lar an­nu­al bar­ri­er by 2022, and their ros­ter — 12 like­ly block­busters which I’ve de­tailed be­low — pro­vides some in­ter­est­ing in­sights in­to the state of drug R&D to­day.

Richard Har­ri­son

First, it’s a re­mark­ably eclec­tic col­lec­tion of ther­a­pies, with sev­er­al built on the 46 new ap­provals the FDA post­ed in 2017 — a record 52 if you in­clude some re­mark­able new bi­o­log­ics. At a time when on­col­o­gy cap­tures the largest sin­gle share of the mon­ey be­ing in­vest­ed in the field, on­ly 1 of the 12 is for treat­ing can­cer. Two are for di­a­betes, and the rest are scat­tered across 9 dif­fer­ent dis­ease ar­eas.

“I like the fact that no one thing dom­i­nates,” says Richard Har­ri­son, the CSO at Clar­i­vate. “It tells me that the in­dus­try is look­ing at a lot more in­di­ca­tions.”

Not on­ly is there an ar­ray of dis­eases rep­re­sent­ed on the list, there are some new play­ers mak­ing their ap­pear­ance for the first time — Al­ny­lam and GW Phar­ma­ceu­ti­cals — high­light­ing how years of in­vest­ment in biotech has be­gun to pay off in re­mark­able ways and with new com­mer­cial op­er­a­tions. An­oth­er small play­er, In­di­v­ior, al­so made the list with the first month­ly dose of buprenor­phine.

The drug R&D in­dus­try went through quite a stretch of low pro­duc­tiv­i­ty over the last decade, Har­ri­son notes. But a com­bi­na­tion of fac­tors — bet­ter clin­i­cal strate­gies, bio­mark­ers and so on — have ul­ti­mate­ly con­spired to cre­ate greater ef­fi­cien­cies at dis­cov­er­ing drugs. And that’s why Clar­i­vate is post­ing the longest list of this kind since they start­ed in 2013.

It’s al­ways hard to pre­dict the fu­ture, Har­ri­son added, but he would like to see the surge con­tin­ue in 2019. All the trends he can point to in 2018 all seem to have some durable fea­tures that should last for some time to come.

And with that, here are the 12.

  1. Hem­li­bra (emi­cizum­ab)

De­vel­op­er: Roche
Dis­ease: He­mo­phil­ia
2022 pro­ject­ed sales: $4 bil­lion

The scoop: It’s no sur­prise to find Hem­li­bra at the top of the list. Roche’s land­mark suc­cess for this drug has every­one in the he­mo­phil­ia mar­ket look­ing at a tec­ton­ic shift in mar­ket share. Hem­li­bra helped ease con­cerns about Roche’s abil­i­ty to roll with the loss of patent pro­tec­tion on three big fran­chise drugs. And it’s like­ly to be the biggest longterm suc­cess on this list, by far. That’s not ex­act­ly what ri­vals at Shire or No­vo Nordisk want to hear. But this is a ma­jor ad­vance for pa­tients, and the first big thing to come along in 20 years in he­mo­phil­ia. There may be big things ahead for this drug, but for now Roche is lead­ing the way.


2. Bik­tarvy (bicte­gravir/emtric­itabine/teno­fovir alafe­namide)

De­vel­op­er: Gilead
Dis­ease: HIV
2022 pro­ject­ed sales: $3.71 bil­lion

The scoop: To be sure, Gilead has some en­er­gized com­pe­ti­tion at GSK’s ma­jor­i­ty owned Vi­iV. Nev­er­the­less, Gilead is build­ing on one of the most durable fran­chis­es in drug de­vel­op­ment, as­sured of a block­buster mar­ket for a sin­gle ther­a­py that will make life eas­i­er for many peo­ple liv­ing with HIV. One day, there may be a cure for the virus. But un­til then, no one knows how to work this field bet­ter than Gilead.


3. Ozem­pic (semaglu­tide)

De­vel­op­er: No­vo Nordisk
Dis­ease: Di­a­betes (stud­ied for obe­si­ty)
2022 pro­ject­ed sales: $3.47 bil­lion

The scoop: You have to give No­vo Nordisk top cred­it for run­ning a savvy de­vel­op­ment pro­gram. They are go­ing af­ter Eli Lil­ly’s Trulic­i­ty, and they came up with the da­ta to prove their drug was bet­ter. And they al­so have some re­mark­able stats on weight loss that in­spired a move in­to the clin­ic for obe­si­ty, with the kind of safe­ty da­ta in hand that would make any added des­ig­na­tion on that front a like­ly block­buster all on its own. Di­a­betes is a rugged­ly com­pet­i­tive field, with a few gi­ants dom­i­nat­ed the land­scape. In that re­spect, No­vo con­tin­ues to punch well above its weight.


4. Er­lea­da (apa­lu­tamide)

De­vel­op­er: J&J
Dis­ease: Non-metasta­t­ic prostate can­cer
2022 pro­ject­ed sales: $2 bil­lion

The scoop: Here again you can see how the biotech ecosys­tem is pay­ing div­i­dends for Big Phar­ma. J&J had some nasty set­backs in 2017, but this drug snagged in its Aragon ac­qui­si­tion looks ready to pay off at a crit­i­cal junc­ture. J&J is fac­ing the near-term loss of patent pro­tec­tion on Zyti­ga, which is sold for metasta­t­ic prostate can­cer. The ap­proval in Feb­ru­ary, months ahead of the nor­mal reg­u­la­to­ry sched­ule, al­so un­der­scores the FDA’s will­ing­ness to run out the green light in record time, par­tic­u­lar­ly in on­col­o­gy.


5. Shin­grix

De­vel­op­er: Glax­o­SmithK­line
Dis­ease: Shin­gles
2022 pro­ject­ed sales: $1.37 bil­lion

The scoop: GSK doesn’t make these lists for its phar­ma prod­ucts. But it still has a vi­brant vac­cines group. New CEO Em­ma Walm­s­ley, though, seems fed up with its chron­ic sec­ond place rank­ing in drug de­vel­op­ment, and in­tends to make some things change as the com­pa­ny fo­cus­es on few­er, but big­ger, new drugs. We’ll see.


6. Patisir­an

De­vel­op­er: Al­ny­lam
Dis­ease: Herid­i­tary TTR Amy­loi­do­sis
2022 pro­ject­ed sales: $1.21 bil­lion

The scoop: Al­ny­lam has some com­pe­ti­tion at Io­n­is, but when an­a­lysts start count­ing the dol­lars, vir­tu­al­ly all of them as­sign the li­on’s share in the field to Al­ny­lam. This is lin­ing up as the Cam­bridge, MA-based biotech’s first ap­proval, and it’s a big one. If this pays off as ex­pect­ed, and some of the peak sales es­ti­mates go much high­er, Al­ny­lam can sus­tain its ground­break­ing RNAi plat­form for some time. It’s an im­pres­sive achieve­ment, no mat­ter how you cut it.


7. Epid­i­olex

De­vel­op­er: GW Phar­ma­ceu­ti­cals
Dis­ease: Dravet syn­drome and Lennox-Gas­taut syn­drome
2022 pro­ject­ed sales: $1.19 bil­lion

The scoop: Per­haps it’s not too sur­pris­ing that a cannabis-based ther­a­py can re­duce the rate of seizures for two rare syn­dromes. But GW has im­pressed an­a­lysts with a set of late-stage re­sults that de­ci­sive­ly makes their case. The first PDU­FA date is loom­ing June 27, and the biotech is the odds-on fa­vorite for bring­ing the block­buster.


8. Aimovig (erenum­ab)

De­vel­op­er: Am­gen/No­var­tis
Dis­ease: Mi­graine
2022 pro­ject­ed sales: $1.17 bil­lion

The scoop: Am­gen and No­var­tis don’t have the on­ly CGRP mi­graine drug head­ed to a like­ly ap­proval. The da­ta on these drugs aren’t dra­mat­i­cal­ly dif­fer­ent. Safe­ty looks good. And play­ers rang­ing from Te­va to Eli Lil­ly to lit­tle Alder (and lat­er Al­ler­gen) are all an­gling for their own piece of the pie. But the two heavy­weights do have the first drug un­der re­view at the FDA. Way out front, they are like­ly to be the first to start chang­ing the stan­dard of care in the field. That’s a big deal, and one they promise to make the most of.


9. Lanadelum­ab

De­vel­op­er: Shire
Dis­ease: Hered­i­tary an­gioede­ma
2022 pro­ject­ed sales: $1.15 bil­lion

The scoop: Back in May, when Shire post­ed the da­ta on lanadelum­ab, it was quick­ly ap­par­ent that Shire’s pipeline star had po­ten­tial stel­lar fu­ture ahead of it. The FDA sig­naled their agree­ment with a quick re­view sched­ule. Shire CEO Flem­ming Orn­skov likes to set stretch goals for the com­pa­ny, and he’s done it here as well, pro­ject­ing $2 bil­lion in peak sales. Even if he doesn’t hit that mark, though, it seems like he’d be hard pressed to miss block­buster sta­tus.


10. Elagolix

De­vel­op­er: Ab­b­Vie
Dis­ease: En­dometrio­sis
2022 pro­ject­ed sales: $1.15 bil­lion

The scoop: Ab­b­Vie would seem to have an ap­proval to mar­ket this drug for en­dometrio­sis al­most in the bag, with sol­id da­ta and an ac­cel­er­at­ed time­line at the FDA that seems to al­most al­ways bode well for de­vel­op­ers. More re­cent­ly, Ab­b­Vie added a full slate of pos­i­tive da­ta from two Phase III stud­ies for uter­ine fi­broids, in­di­cat­ing that broad­er and bet­ter things lie ahead for this new fran­chise ther­a­py. Clar­i­vate’s num­ber here is right in line with mar­ket con­sen­sus, but Ge­of­frey Porges is cheer­ing things along with a $1.4 bil­lion pro­jec­tion. The com­pa­ny got this drug in a $575 mil­lion deal it struck in 2010 with Neu­ro­crine $NBIX, which stands to earn a roy­al­ty pay­out on an ap­proval.


11. Steglatro (er­tugliflozin)

De­vel­op­er: Pfiz­er/Mer­ck
Dis­ease: Di­a­betes
2022 pro­ject­ed sales: $1.09 bil­lion

The scoop: Pfiz­er and Mer­ck are late to the SGLT2 par­ty. Sev­er­al years late, to be ex­act. Eli Lil­ly got out front with Jar­diance and a full set of ri­vals fol­lowed in their paths. Nev­er­the­less, di­a­betes is a mas­sive and grow­ing mar­ket, leav­ing a new ar­rival like this still with­in reach of a block­buster re­turn. Steglatro isn’t win­ning awards for in­no­va­tion, but it’s help­ing pa­tients and of­fer­ing some com­pe­ti­tion in an in­tense­ly com­pet­i­tive are­na. That’s worth some re­ward.


12. Sublo­cade (Once-month­ly buprenor­phine)

De­vel­op­er: In­di­v­ior
Dis­ease: Opi­oid de­pen­dence
2022 pro­ject­ed sales: $1.07 bil­lion

The scoop: In­di­v­ior need­ed this drug ap­proval, bad­ly. With gener­ic ri­vals about to crowd in on its stan­dard treat­ment, a month­ly in­jectable of buprenor­phine — us­ing a mild opi­oid — is a wel­come ad­di­tion to the field of eas­ing opi­oid with­draw­al — one of the hottest is­sues of the day. The FDA in­di­cat­ed that it would help, and with the agency lean­ing in fa­vor of the in­dus­try like nev­er be­fore, that’s mon­ey in the bank.

Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Hal Barron, GSK R&D chief

GSK's Hal Bar­ron ax­es a once-prized drug from J&J, con­tin­u­ing shift away from res­pi­ra­to­ry

Hal Barron’s revamp of the GlaxoSmithKline pipeline continued yesterday, as the British pharma announced they axed an asthma drug they once promised over $200 million to acquire.

Then led by CEO Andrew Witty and R&D chief Patrick Vallance, GSK picked up the drug, known elegantly as GSK3772847, from J&J in 2016, hoping to expand on the beachhead in asthma they had established the year prior with Breo Ellipta. They promised up to $227 million in upfront payments and milestones.

Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

Re­gen­eron posts sec­ond look on Covid-19 an­ti­body cock­tail, boost­ing its case for EUA — but what about symp­tom al­le­vi­a­tion?

Regeneron has revealed a second cut of data on its Covid-19 antibody cocktail in the outpatient setting — data that it has sent straight to the FDA to boost its emergency use authorization request.

The new results reinforce what’s reported from the same trial last month, Regeneron said, incorporating a total of 799 non-hospitalized patients with mild-to-moderate disease. REGN-COV2 reduced viral load and patient medical visits (anything ranging from hospitalizations, emergency room, urgent care visits to physician office and telemedicine visits), meeting all the key endpoints.

Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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