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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.