The top 15 would-be blockbusters in the pipeline prepping for a 2017 launch
This is the year that a whole slate of Big Pharmas should be able to score bragging rights to blockbuster drug launches. And after last year’s paltry roundup of new drug approvals, they all desperately need it.
Every year EP Vantage likes to do its breakdown of the top 20 small molecules and biologics aiming to hit the market, ranked by estimated sales potential 5 years down the road. (Being a bit agnostic about this, we mashed the two lists into one and ranked them all by peak sales forecasts.)
There are 15 would-be blockbusters in EvaluatePharma’s top 20. And this year’s list includes some notable standouts.
AstraZeneca has one drug on the list, its PD-L1 checkpoint inhibitor durvalumab, which is make or break for this pharma giant. The diversified J&J, which has three drugs on the blockbuster list, is looking to capitalize on some earlier dealmaking. Eli Lilly still has a point to make with baricitinib, hoping to show that it can consistently develop new blockbusters. Sanofi and Regeneron have some scores to settle with dupilumab. And Roche is back with a potential megablockbuster to add — after a delay of game near the end of last year.
You’ll even find GlaxoSmithKline on the list with sirukumab, which you’ll find near the bottom, partnered with J&J. To be sure, Shingrix is also likely to come close to blockbuster status, giving the company more to be pleased with from its vaccines division. But the company manages to consistently disappoint analysts with an unexciting late-stage pipeline.
A couple of biotechs make the grade. Tesaro is up top with niraparib (where it will weigh in against a striving AstraZeneca). And Kite is out to score the biggest new entry among the pioneering CAR-Ts. Both will be looking to make a big change in growing commercialization arms.
Here’s a snapshot of the 15 new drugs launching this year that can reasonably expect to hit blockbuster status in 2022. Just remember, peak sales estimates are consistently disappointing. Sell-side analysts often overlook just how hard payers can fight against new entries with big prices. And right now, who really knows what the Trump administration has in mind for keeping its promise to slash drug prices?
Dupilumab — $4.6 billion
Dupixent fits the bill for a monster therapy. Another big drug from the team of Sanofi and Regeneron, this one focused on atopic dermatitis — eczema to you and me. This is the first monoclonal antibody that blocks both Il-4 and IL-13 cytokines, and there’s nothing that looks like a rival threat on the near horizon, leaving these two big players a lot of room to move. Chance of approval: High.
Ocrelizumab — $4.0 billion
Roche’s Ocrevus was supposed to be on the list of 2016 blockbusters, but manufacturing issues — sound familiar? — got in the way late last year, shoving back a prospective approval for this MS blockbuster into 2017. Chances of approval: High.
Durvalumab — $2.3 billion
By itself, the PD-L1 checkpoint inhibitor durvalumab from AstraZeneca will have a hard time living up to the big future that the pharma giant now requires. That’s why AZ switched gears to combine it with tremelimumab for first-line lung cancer. And if it’s approved, you can be sure that AstraZeneca’s sales team will push it as hard as they can. CEO Pascal Soriot has his back up against a rock now, with revenue still sliding. Failure is not an option, but it’s a real threat — even if this drug simply doesn’t live up to some big expectations.
Semaglutide — $2.0 billion
The big news from Novo Nordisk’s key Phase III study was that their weekly GLP-1 candidate significantly cut the risk of cardio events. The bad news: It just might blind you. Add it all up, though, and you have a data set that Novo will take to regulators with high expectations of an approval, and a strong position to protect its big GLP-1 position in the huge diabetes market. Big, though, doesn’t mean expanding. Novo and its rivals are struggling to maintain a grip on the diabetes market, and they’re losing. New entries like this are key to their futures.
Niraparib — $1.8 billion
Tesaro has big plans for its PARP inhibitor niraparib. Under a speedy review at the FDA, the biotech has been eager to get out into the market and take on AstraZeneca’s Lynparza. Lynparza, though, may soon have a better profile than it acquired when the agency gave it an accelerated approval. And other PARPs, focused on different patient populations, will be crowding in in search of different approvals to expand their use. Clovis is out with rucaparib already, look for Pfizer to follow with talazoparib.
Baricitinib — $1.8 billion
Eli Lilly intended to market this rheumatoid arthritis drug as Olumiant, and it has pursued a wide ranging clinical program to gather proof that it’s effective over a lengthy period of time, with improved performance over Humira. So far so good for Lilly, which isn’t expected to face much resistance from regulators. But Lilly tends to gravitate to competitive fields, and it will have to fight some battles to carve market share.
Ribociclib — $1.5 billion
In the final stretch in its journey to regulators, Novartis posted a positive snapshot of pivotal Phase III data on its CDK 4/6 contender ribociclib (LEE011), setting up a likely showdown with Pfizer in treating breast cancer. The headline figure from ESMO was that ribociclib combined with letrozole reduced the risk of death or progression by 44% among first-line patients compared to letrozole alone, offering further encouragement to the pharma giant that it’s right on track to gaining an approval for this drug this year.
Spinraza — $1.46 billion
Biogen won an approval for this spinal muscular atrophy drug recently, then managed to surprise a lot of analysts with a sticker price that starts at $750,000 for the first year. That may not have earned much attention in the past, but with the spotlight on drug prices, more than a few thought that the biotech company could find itself in the cross hairs of @realDonaldTrump. That hasn’t happened, yet.
Apalutamide (ARN-509) — $1.45 billion
Here’s a drug that you may not remember. J&J struck one of its classic $1 billion deals for this drug, including $650 million upfront, when it bought Aragon from Rich Heyman and his team back in 2013. J&J kept it quiet, but it hustled along with plans to push through late-stage development ASAP with this next-gen anti-androgen drug for prostate cancer. And now here they are, four years later with a would-be blockbuster on their hands. And don’t you think other companies regret not making a few of these billion-dollar bets as well?
KTE-C19 — $1.41 billion
Kite Pharmaceuticals may or may not be the first company to win an approval for a CAR-T. Novartis could beat them to the punch, with both expecting to complete applications in early 2017. And there are a few naysayers who remain deeply skeptical, demanding to see more than 3-month results on patients. But Evaluate gives Kite the edge on hitting blockbuster status first with a drug that reengineers patients’ T cells into a cancer drug. This would be Kite’s first marketed therapy, and they’re moving at a rapid pace.
Neratinib — $1.25 billion
While some analysts have been deeply skeptical about this drug’s prospects due to its well established link to severe diarrhea, Puma’s team has been pushing this one along for breast cancer at a steady pace. The bear position on Puma is that the drug could be too toxic even for the FDA, which has proven willing to put up with significant threats for drugs initially aimed at dying patients. Bulls believe that the safety bar is low enough to clear.
Guselkumab — $1.2 billion
J&J hasn’t been the least bit shy about touting the positive late-stage data that it has accrued for psoriasis. J&J’s second drug on the top 15 will set out to increase its presence in a market where it’s been building sales for Stelara while maintaining an old mainstay, Remicade, an anti-TNF drug like Humira. This new drug is slated to arrive as biosimilars for both of the old drugs are angling to hit the market, though AbbVie has vowed to fight to the bitter end over Humira’s patent protection. J&J, though, believes it has the better drug, which was in-licensed from MorphoSys.
Eucrisa (crisaborole) — $1.15 billion
Pfizer won the FDA approval for eczema late in 2016, putting it on track for a launch in early 2017. Pfizer snapped up the non-steroidal topical PDE4 inhibitor with anti-inflammatory properties last May when it acquired Anacor Pharmaceuticals for $5.2 billion. The drug came through back in mid-2015 in a pair of studies which enrolled more than 1,500 patients, beating out a placebo and posting an acceptable safety profile. Once dupilumab hits the market, though, Pfizer will be up against some heavyweight competition.
Sirukumab — $1.13 billion
J&J has repeatedly tapped sirukumab as a key part of its Phase III effort to line up major new products for the marketing group. GSK, meanwhile, has been trying to overcome persistent criticism that its pipeline lacks pizzazz. In their deal on sirukumab, GSK gained commercial rights in the US and the Western Hemisphere, while J&J lined up Europe and the rest of the world. Mixed data in a head-to-head with Humira, though, will make some analysts wonder how this drug will fair in a market fight.
SD-809 (deutetrabenazine) — $1 billion
Teva made the list, just barely. The FDA rejected SD-809 for Huntington’s disease (it’s been resubmitted), but came back with positive data on tardive dyskinesia. A year-and-a-half ago Teva $TEVA splurged on a $3.5 billion acquisition of Auspex, bagging the new and what it hoped was an improved drug for Huntington’s. Now it’s saying that its second late-stage study shows that the drug is clearly a success, but there are still some significant problems to address. An approval is likely to set up a head-to-head competition with Neurocrine, which might have the better drug.