Summary: Vanda Pharmaceuticals reported its second-quarter 2024 financial and operational results, emphasizing efforts to expand the use of Hetlioz (tasimelteon) for pediatric insomnia and jet lag disorder. The company notes its financial performance was impacted by generic competition, showing a decrease in net product sales for Hetlioz.
Key Takeaways
- Expansion Efforts: Vanda Pharmaceuticals is working to expand the use of Hetlioz for pediatric insomnia and jet lag disorder, including initiating the Hetlioz LQ program for pediatric insomnia.
- Regulatory Challenges: The company is pursuing FDA approval for new uses of Hetlioz and challenging the FDA’s rejection of its supplemental New Drug Application for jet lag disorder.
- Financial Impact: Vanda’s second-quarter financial results showed a decrease in Hetlioz sales due to increased generic competition, with net product sales down 15% compared to the same period in 2023.
Vanda Pharmaceuticals reported its second-quarter 2024 financial and operational results, highlighting efforts to expand Hetlioz’s (tasimelteon) use for pediatric insomnia and jet lag disorder, along with regulatory hurdles.
Hetlioz is currently approved for the treatment of non-24-hour sleep-wake disorder.
During the quarter, 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, according to a release from Vanda. There are currently no approved treatments for pediatric insomnia.
Vanda continues to pursue US Food and Drug Administration (FDA) approval for Hetlioz for the treatment 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 lawsuit asserting that US Patent No 11,285,129 will be infringed by generic versions of Hetlioz marketed by Teva Pharmaceuticals USA Inc and Apotex Inc and Apotex Corp is currently pending in the US District Court for the District of Delaware. Vanda announced in July that the District Court ordered that Vanda’s Hetlioz lawsuit may proceed.
Additionally, Vanda submitted a Marketing Authorization Application for Hetlioz and a Line Extension Application for Hetlioz LQ to the European Medicines Agency for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome.
Hetlioz Financial Highlights
Second quarter of 2024:
- Hetlioz net product sales were $18.7 million in the second quarter of 2024, a 15% decrease compared to $22 million in the second quarter of 2023 and a 7% decrease compared to $20.1 million in the first quarter of 2024.
- The decrease relative to the second quarter of 2023 was the result of continued generic competition in the US, according to Vanda.
First six months of 2024:
- Hetlioz net product sales were $38.8 million in the first six months of 2024, a 37% decrease compared to $61.6 million in the first six months of 2023.
- The decrease relative to the first six months of 2023 was the result of continued generic competition in the US, according to Vanda.
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