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
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
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
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
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
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
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.