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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.