Vanda reports a significant decline in Hetlioz sales while facing FDA review and legal challenges to expand its indications for treating insomnia and jet lag disorder.

Summary: Vanda Pharmaceuticals reported a significant decline in Q1 2024 sales for Hetlioz, attributed to increased generic competition. The company is focusing on expanding Hetlioz indications to include insomnia and jet lag disorder, despite receiving an FDA complete response letter and ongoing legal battles. Vanda plans to initiate a Hetlioz LQ program for pediatric insomnia. With uncertainties in the US market and other drug launches pending, Vanda is unable to provide financial guidance for 2024.

Key Takeaways:

Hetlioz sales dropped by 49% in Q1 2024 due to increased generic competition in the US market.
Vanda is pursuing FDA approval for Hetlioz in insomnia and jet lag disorder, despite receiving a complete response letter from the FDA and facing ongoing legal battles over patent claims.
Vanda plans to launch a Hetlioz LQ program targeting pediatric insomnia, aiming to fill a gap in approved treatments and potentially secure market exclusivity into the 2040s.

Vanda Pharmaceuticals Inc reported its operational results for the first quarter ending March 31, providing updates on the developments surrounding Hetlioz (tasimelteon) as it seeks to expand indications to include the treatment of insomnia and jet lag disorder.

Hetlioz is currently approved for the treatment of non-24-hour sleep-wake disorder.

Pursuing New Indications

Vanda announced in March that it received a complete response letter from the US Food and Drug Administration (FDA) related to the supplemental New Drug Application (sNDA) for Hetlioz in the treatment of insomnia. Vanda is reviewing the complete response letter and evaluating its next steps.

In addition to insomnia, Vanda continues to pursue FDA approval of Hetlioz in the treatment of jet lag disorder where the final agency rejection of Vanda’s application is being challenged in the US Court of Appeals for the DC Circuit.

Patent Challenges

Vanda announced in April that the US Supreme Court denied its petition for a writ of certiorari to review the decision of the US Court of Appeals for the Federal Circuit in Vanda’s Hetlioz Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA Inc, Apotex Inc, and Apotex Corp. The lower court decision held that certain claims of Vanda’s US Patent Nos RE46,604; 9,730,910; 10,149,829; and 10,376,487 were invalid.

Vanda’s suit asserting US Patent No 11,285,129 will be infringed by Teva’s and Apotex’s generic versions of Hetlioz is currently pending in the US District Court for the District of Delaware.

Pediatric Insomnia Program

Additionally, Vanda is currently planning to initiate a Hetlioz LQ program in pediatric insomnia. There are currently no approved treatments for pediatric insomnia. If ultimately approved for marketing, the addressable patient population for Hetlioz LQ would be significantly expanded and market exclusivity would be expected to last into the 2040s, according to a release from Vanda.

Financial Results and Outlook

For the quarter, Hetlioz’s net product sales were $20.1 million, a 49% decrease compared to $39.6 million in the first quarter of 2023, and a 5% decrease compared to $21.1 million in the fourth quarter of 2023. The decrease relative to the first quarter of 2023 was the result of continued generic competition in the US, according to a release from Vanda.

Given continuing uncertainties surrounding the US market for Hetlioz as a result of continued generic competition in the US, among other factors, Vanda is unable to provide 2024 financial guidance.