The top 10 prospec­tive block­buster drug launch­es slat­ed for 2018 — Eval­u­ate

Im­age: Gilead’s John Mil­li­gan. Get­ty


Every­body in bio­phar­ma talks about un­met med­ical needs when they re­view their late-stage pipeline, but it’s the mar­ket po­ten­tial that will ei­ther whip up in­vestors or leave them cold about any in­no­va­tion. The top 10 prospec­tive drug launch­es loom­ing in 2018 — as se­lect­ed by Eval­u­ate in its 2018 pre­view — un­der­scores all the po­ten­tial of the would-be block­busters that al­ways dom­i­nate bio­phar­ma R&D news.

So what will we be look­ing out for?

Some very well es­tab­lished mar­ket­ing com­pa­nies are in the mix for a 2018 block­buster launch. There are new ad­vances in HIV and di­a­betes, and it’s not the least bit un­ex­pect­ed to find that 6 of the 10 are ei­ther new can­cer ther­a­pies or drugs for rare dis­eases — two fields where the FDA is now square­ly be­hind rapid launch­es.

The po­ten­tial sales fig­ures are pro­ject­ed for 2022 by Eval­u­ate.

1 Bicte­gravir/F/TAF — Gilead

Peak sales: $5.05 bil­lion
Cat­e­go­ry: HIV

The scoop: The HIV triplet that Gilead has poised for the mar­ket­place with a Feb­ru­ary 12 PDU­FA date il­lus­trates a few things about the com­pa­ny and its po­si­tion in the mar­ket. Gilead has been a dom­i­nant play­er in HIV for years now, and wasn’t about to let Glax­o­SmithK­line just walk away with any part of their rev­enue with their new­ly ap­proved two drug com­bo Ju­lu­ca — which it­self is a land­mark achieve­ment in the dri­ve to make these cock­tail ther­a­pies eas­i­er than ever to re­main com­pli­ant with. Gilead’s un­der­stand­ing of the HIV mar­ket is now part of its DNA, and an­a­lysts are quick to give it high marks for be­ing com­plete­ly prepped on the roll­out when that ap­proval comes through — prob­a­bly soon­er than lat­er.


2 Semaglu­tide — No­vo Nordisk

Peak sales: $2.7 bil­lion
Cat­e­go­ry: Di­a­betes

The scoop: Just a few days ago the FDA hit the green light for No­vo Nordisk’s semaglu­tide, a once-week­ly GLP-1 di­a­betes drug that came through a ma­jor Phase III pro­gram with fly­ing col­ors. In fact, their drug — to be sold as Ozem­pic — beat out Trulic­i­ty in a head-to-head study, which will put con­sid­er­able pres­sure on Eli Lil­ly’s big new drug. Tapped as a block­buster with more than $2 bil­lion in peak sales po­ten­tial, No­vo has al­so start­ed up a huge obe­si­ty tri­al, in­ter­est­ed in see­ing if it can get pa­tients to shed the weight that can cause di­a­betes in the first place. That makes this drug a clear and present threat to a whole slate of drugs on the mar­ket, none of which are do­ing very well.


3 Epaca­do­stat — In­cyte

Peak sales: $1.94 bil­lion
Cat­e­go­ry: On­col­o­gy

Hervé Hop­penot

The scoop: The leader in the IDO1 field is sub­ject­ed to a close-up with every new cut of the da­ta. That hasn’t al­ways gone ac­cord­ing to plan at In­cyte, but re­searchers have stuck close enough to the path to stay on track with fore­casts of a ma­jor block­buster fu­ture in can­cer. The im­por­tance of this drug for In­cyte can’t be over­es­ti­mat­ed. And every move from a com­peti­tor, in­clud­ing the pow­er­house team at Bris­tol-My­ers Squibb, which paid $1.25 bil­lion to get their hands on theirs, gets equal scruti­ny. Get­ting to the top of the field is one thing, stay­ing there will be some­thing else. One part of In­cyte’s plan for main­tain­ing its po­si­tion is by com­bin­ing its drug with sev­er­al dif­fer­ent check­points. And In­cyte CEO Hervé Hop­penot even re­cent­ly went out and bought one of his own, af­ter the first deal left him with a check­point with an odd­ly check­ered his­to­ry in the clin­ic.


4 Ro­va-T — Ab­b­Vie

Peak sales: $1.44 bil­lion
Cat­e­go­ry: On­col­o­gy

The scoop: Ab­b­Vie paid $5.8 bil­lion in cash for this drug, promis­ing up to $4 bil­lion more in mile­stones to ac­quire the lit­tle-known biotech uni­corn Stem­cen­tryx. And with mon­ey like that on the ta­ble, ex­pec­ta­tions are run­ning high. Com­bined with Bris­tol-My­ers’ Op­di­vo and Yer­voy, Ab­b­Vie is bet­ting that it has a win­ner in small cell lung can­cer, though its first cut of the ear­ly da­ta last year failed to im­press any­one out­side of the com­pa­ny. The drug drops a cy­to­tox­ic bomb right on DLL3-ex­press­ing can­cer cells com­mon in SCLC.


5 Ozan­i­mod — Cel­gene

Peak sales: $1.27 bil­lion
Cat­e­go­ry: Mul­ti­ple scle­ro­sis

The scoop: Cel­gene ex­ecs are not the shy type when it comes to tout­ing an ex­per­i­men­tal drug’s sales po­ten­tial. Their ini­tial mark: $4 bil­lion to $6 bil­lion. That num­ber has been com­ing down, though. Still, Ge­of­frey Porges re­mained a big be­liev­er at the end of Oc­to­ber as Cel­gene rolled out ap­prov­able num­bers. His es­ti­mate: $2.9 bil­lion in peak sales.


6 Apa­lu­tamide — J&J

Peak sales: $1.24 bil­lion
Cat­e­go­ry: On­col­o­gy

Rich Hey­man

The scoop: This drug (ARN-509) has been on my radar for years. I was fol­low­ing it close­ly when J&J came in and scooped up Rich Hey­man’s Aragon in one of its block­buster deals, with $650 mil­lion for the up­front alone. It’s thrilling to see it head­ed to reg­u­la­tors, even though we still haven’t seen the da­ta. J&J is the on­ly top 10 phar­ma com­pa­ny on this list, and it wouldn’t be here with­out the biotech team at Aragon. It al­so wouldn’t be here with­out an ag­gres­sive busi­ness de­vel­op­ment team that struck a line­up of bil­lion-dol­lar deals.


7 Elagolix — Ab­b­Vie

Peak sales: $1.21 bil­lion
Cat­e­go­ry: Women’s health

The scoop: I got a chance to pick through the Phase III da­ta last May, so no big sur­prise that this qual­i­fies as Ab­b­Vie’s sec­ond drug on the top 10. The oral go­nadotropin-re­leas­ing hor­mone (GnRH) re­cep­tor an­tag­o­nist demon­strat­ed some clear, dose-de­pen­dent re­spons­es that eas­i­ly out­paced the place­bo arms in two Phase III tri­als, each with more than 800 women en­rolled in them. Both stud­ies tracked clin­i­cal re­spons­es for dys­men­or­rhea — acute and po­ten­tial­ly dis­abling men­stru­al pain — as well as non­men­stru­al pelvic pain. Ab­b­Vie has been lin­ing up block­busters for the day — prob­a­bly some years from now — when it won’t have the Hu­mi­ra gold mine to re­ly on any­more. This drug looks like it should make that port­fo­lio.


8 AVXS-101 — Avex­is

Peak sales: $1.14 bil­lion
Cat­e­go­ry: Rare dis­eases

The scoop: Avex­is has a piv­otal study in the works for this drug, but it won’t be wait­ing for the da­ta be­fore seek­ing an ap­proval. A few weeks ago we saw some ex­cel­lent da­ta from a tiny study of 15 in­fants treat­ed with this gene ther­a­py for spinal mus­cu­lar at­ro­phy. And the agency might well be in a mood to hur­ry it out to save pa­tients fac­ing a lethal dis­ease. The ther­a­py pos­es a di­rect threat to Bio­gen’s new fran­chise for Spin­raza, priced at $750,000 for the first year — one of the top 10 most ex­pen­sive ther­a­pies in the world.


9 Lanadelum­ab — Shire

Peak sales: $1.12 bil­lion
Cat­e­go­ry: Rare dis­eases

Flem­ming Orn­skov

The scoop: Back in May we got a peek at some stel­lar Phase III da­ta for this drug, an­oth­er rare dis­ease ther­a­py like­ly to de­but with a six-fig­ure stick­er price. Shire paid close to $6 bil­lion for Dyax, large­ly on the promise of the next-gen HAE ther­a­py. And CEO Flem­ming Orn­skov added a $4 CVR worth $656 mil­lion if the drug is ap­proved. That pay­off could be loom­ing in 2018 if the da­ta pass­es muster with reg­u­la­tors. Orn­skov is trans­form­ing Shire in­to a rare dis­ease play­er with glob­al heft. This drug will keep the com­pa­ny point­ed in that di­rec­tion.


10 Epid­i­olex — GW Phar­ma

Peak sales: $960 mil­lion
Cat­e­go­ry: Rare dis­eases

The scoop: This is close enough to a bil­lion dol­lars to qual­i­fy for the block­buster mar­ket. The GW crew work­ing on epid­i­olex has been on a roll all year long. They get start­ed with a slate of up­beat da­ta in March, when the drug scored with pos­i­tive piv­otal da­ta for Dravet syn­drome, a rare form of se­vere epilep­sy. A few months lat­er, it was Lennox-Gas­taut syn­drome. Not all an­a­lysts have been this con­ser­v­a­tive with peak sales es­ti­mates, with some break­ing the $2 bil­lion mark. But this biotech ap­pears poised for a trans­for­ma­tion­al year.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.

“Macrophages are interesting because we were all educated probably 20 years ago that they are the big eaters in the immune system, but they’re really the orchestrators of the immune system,” CEO Christine Bunt said.

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

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CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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