Summary: Vanda Pharmaceuticals reported a 28% drop in net product sales for Hetlioz over the first nine months of 2024, attributing the decline to increased generic competition in the US. The company aims to bolster revenue and diversify by seeking FDA approvals for additional indications, including jet lag disorder and insomnia, and has launched a Hetlioz LQ program for pediatric insomnia. Vanda is also challenging the FDA’s rejection of its supplemental New Drug Application for jet lag and is pursuing litigation to protect Hetlioz’s patent, with a trial set for early 2026. Meanwhile, a European Medicines Agency decision on Hetlioz for Smith-Magenis Syndrome is expected in 2025.
Key Takeaways:
- Sales Impact from Generic Competition: Hetlioz saw a 28% decrease in net sales year-to-date due to generic competitors in the US, although Q3 sales showed a slight increase.
- Expansion Efforts: Vanda is pursuing FDA approvals for Hetlioz to treat jet lag disorder and insomnia and has initiated a new Hetlioz LQ program targeting pediatric insomnia.
- Ongoing Patent Litigation and EMA Review: Vanda is actively defending its Hetlioz patent against generics, with a jury trial scheduled for 2026, and anticipates a decision from the European Medicines Agency on its application for Hetlioz for Smith-Magenis Syndrome by early 2025.
Vanda Pharmaceuticals Inc announced financial and operational results for the third quarter, which showed a 28% decrease in net product sales for Hetlioz during the first nine months of the year. Vanda attributes the decrease to continued generic competition in the United States.
Hetlioz is a melatonin receptor agonist that is US Food and Drug Administration-approved for both non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome in patients 16 years of age and older. In addition, Hetlioz LQ oral suspension is approved for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age.
“We are committed to growing our revenue from our existing products and continuing to diversify our sources of revenue through indication expansion and new product development,” says Mihael H. Polymeropoulos, MD, Vanda president, CEO, and chairman of the board, in a release.
For Q3 alone, Hetlioz’s net product sales were $17.9 million, a 2% increase compared to $17.5 million in the third quarter of 2023.
2024 Hetlioz Highlights
Vanda has initiated a Hetlioz LQ program in pediatric insomnia. Although the prevalence of insomnia in children is difficult to determine, it is estimated that 20-40% of children experience significant sleep problems. There are currently no approved treatments for pediatric insomnia.
Vanda continues to pursue FDA approval for Hetlioz for the treatments of jet lag disorder and insomnia. Vanda is challenging the FDA’s rejection of Vanda’s supplemental New Drug Application (sNDA) for the treatment of jet lag disorder in the US Court of Appeals for the DC Circuit. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the insomnia sNDA.
Vanda’s litigation asserting Hetlioz Patent No 11,285,129 against generic manufacturers is currently pending in the US District Court for the District of Delaware. A jury trial has been scheduled for the first quarter of 2026.
Additionally, European Medicines Agency action on Vanda’s Marketing Authorization Application for Hetlioz and Hetlioz LQ for Smith-Magenis Syndrome is expected in the first quarter of 2025.
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