Project name: vortioxetine/Lu AA21004
Peak sales estimate: $2 billion, according to Lundbeck/Takeda; $1.85 billion, according to Deutsche Bank
Approved: Sept. 30
Companies: Lundbeck and Takeda
Winning FDA approval isn't easy in antidepressants, where placebo effects often thwart promising programs. But Brintellix (vortioxetine/Lu AA21004) outperformed the placebo in 6 clinical studies, and development partners Lundbeck and Takeda believe they have a $2-billion-a-year winner.
They've believed it for some time: In the summer, ahead of the FDA approval announcement, Denmark's Lundbeck and Japan's Takeda announced plans to hire sales reps to market the nascent drug. Brintellix is an atypical antidepressant in a market in which first-line therapeutics in more established drug categories often hit or miss, depending on the patient.
Postapproval, Lundbeck and Takeda unfolded more data that analysts say could boost sales by as much as $350 million. Brintellix, as it turns out, not only eases depression but also helps improve patients' ability to think, concentrate and remember--aspects of cognition that often suffer in patients with depression. The data, released in December, prompted Deutsche Bank analyst Tim Race to boost his 2019 earnings projection for Brintellix from $1.5 billion to $1.85 billion.
That's welcome news for Lundbeck, which has been looking for a new drug franchise capable of replacing Lexapro, the selective serotonin reuptake inhibitor (SSRI) for depression and general anxiety disorder it developed with Forest Labs ($FRX). The FDA accepted an NDA from Lundbeck and its partner Takeda on Brintellix in December 2012.
Brintellix will be sold in 5-mg, 10-mg, 15-mg and 20-mg tablets. Clinical trial participants taking Brintellix reported side effects including nausea, constipation and vomiting. Like other antidepressants, the drug comes with a boxed warning on increased risk of suicidal thoughts and behavior in children, adolescents and young adults.
Lundbeck and Takeda have also touted separate data on Brintellix, comparing it favorably with agomelatine, which Servier sells in Europe as Valdoxan. Agomelatine never made it to the U.S. market. Novartis ($NVS) had taken control of U.S. rights but never pursued an approval.
Next for Brintellix could be testing in attention deficit hyperactivity disorder. Noting the drug's effect on attention and decision-making, Lundbeck and Takeda reportedly may launch ADHD trials in 2014. -- Galen Moore (email | Twitter)
Shutdown looming, FDA approves new depression drug from Lundbeck, Takeda
Lundbeck touts promising head-to-head data on depression drug Brintellix
Think fast: A new cognition study could add $350M to Lundbeck's Brintellix sales