Supernus Pharmaceuticals has two key selling points for its newly minted Qelbree: It's the first non-stimulant ADHD drug to win approval in a decade, and it appears to start working more quickly than its future rivals do.
That may not be enough to make Qelbree into a blockbuster, analysts say. But capturing just a few percentage points of market share would be enough for decent-sized sales.
The FDA gave its go-ahead to Qelbree, previously known as SPN-812, for attention-deficit hyperactivity disorder (ADHD) in children between the ages of 6 to 17. Supernus is plotting its U.S. launch for the second quarter, which should put it on track to capitalize on the key back-to-school season when roughly 40% of ADHD prescription changes take place, Jefferies analysts wrote in a note to clients.
Qelbree will have to vie for space in a market crowded by Eli Lilly’s Strattera and Shire’s Intuniv, both of which have cheaper generics on tap.
Intuniv was the last branded, non-scheduled ADHD med to win the FDA's blessing, way back in 2009. Since then, a suite of low-cost copycats have swept the market. The case is the same for Eli Lilly's Strattera, which posted $535 million in U.S. sales in 2016—the last full year before generic rivals entered the equation.
Qelbree won't beat out those drugs on price alone, but Supernus has laid plans to boost the med's profile. Beyond education efforts, the company will offer samples of Qelbree to patients and doctors interested in testing out the new drug—something that simply wouldn't be possible with a stimulant-based medication, the Jefferies analysts pointed out.
And while there isn't any head-to-head data, Qelbree appears to sidestep the rare liver toxicity and hypotension concerns of Strattera and Intuniv, respectively, the Jefferies analysts noted. It could also beat out market leader Strattera on speed of action, they said.
Meanwhile, the notion that the ADHD market is overcrowded with treatment options is a "misconception," Jack Khattar, CEO and president of Supernus, said via email. In reality, "the majority of the current options are a reformulation of just two stimulant molecules, methylphenidate and amphetamine." Qelbree is only the fourth non-controlled ADHD med to win FDA approval, he pointed out.
With just a 4% to 5% share of the market, Qelbree could reap more than $400 million in peak sales, the Jefferies analysts predicted.
As for 2022, the Jefferies team forecasted sales of around $54 million, which they expect to jump to roughly $383 million by 2026.
Supernus is keeping its price tag close to the vest, though CEO Khattar said the cost of Qelbree would be competitive with other ADHD meds on the market. The company will offer a patient access program at launch, which includes co-pay assistance, he added.
The FDA approved Qelbree on four phase 3 trials covering more than 1,000 patients ages 6 to 17 years old. In March 2019, the company unveiled phase 3 data that showed its 400-mg dose had bested placebo at reducing the ADHD symptoms in adolescents, while a 600-mg dose “narrowly missed” statistical significance.
Notably, Supernus said that the 400-mg dose charted statistically significant onset of action at the second-week mark, which continued until the study ended at week 7.
In fact, the drug could start to improve symptoms within the first week, a Supernus spokesperson said over email. That could give Qelbree an edge over Strattera, which takes some 4 to 8 weeks to start working.
Qelbree's path to approval wasn't without its bumps. In November, Qelbree's application in kids and teens was slapped with a Complete Response Letter, which Supernus pinned on the recent relocation of an in-house lab for analytical testing. The company said it would work with the FDA on the matter and pointed out that its application listed other, non-affected facilities for product release.
The company already has its sights set on a follow-up indication in older patients. The company in December shared positive data on Qelbree in adults, laying plans to file a supplementary application with the FDA in the second half of the year.
Editor's note: This story was updated with additional comments from Supernus.