- A trio of drugmakers are launching a Parkinson's disease drug that addresses the motor problems associated with the condition in the U.S. after an approval earlier this year.
- Newron Pharmaceuticals' Xadago (safinamide) gained the Food and Drug Administration's approval in March as an add-on treatment for Parkinson's patients taking a combination of levodopa/carbidopa who still experience periods of heightened symptoms such as dyskinesia.
- The Italy-based drugmaker previously handed over licensing rights to Xadago to Zambon for all countries minus Japan and a few others in Asia. Zambon, another Italian pharma, then sold off U.S. rights to Kentucky-based US WorldMeds, which has previously planned to employ more than 60 sales reps to roll out Xadago stateside.
Unfortunately for Newron, Xadago's U.S. approval doesn't mean much for the company's bottom lines. The company has effectively licensed out its drug worldwide, but the returns haven't been anything to write home about.
In 2016, Newron reported just €4.7 million ($5.37 million) in licensing and royalty revenue.
With the U.S. launch, Xadago is has now broke into the markets of 12 different countries. According to Newron, it's the first drug in more than 10 years to be approved stateside for treating Parkinson's disease patients with motor fluctuations.
Xadago's approval followed two clinical trials that enrolled roughly 1,200 patients combined. Across those studies, participants receiving the drug experienced more "on" time — spans in which their Parkinson's symptoms reduced — than those on placebo.
What's more, patients in the treatment arm demonstrated less "troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo," according to a statement from the FDA. "The increase in 'on' time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.
Though Newron may not see astronomical returns on Xadago, Parkinson's disease treatments are proving lucrative. The disease affects about one million people in the U.S. alone, and industry analysis firm GBI Research has predicted the global drug market for the disease will edge over $3 billion by 2021.