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.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.