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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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