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.
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.
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)
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)
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.
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.
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.
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)
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.
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.
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)
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)
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.
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