Vanda Pharmaceuticals Inc generated total revenues of $14.8 million for the third quarter of 2014, up from $10.9 million for the second quarter of 2014 and $8.7 million for the third quarter of 2013. Net product revenues related to US sales of Hetlioz for Non-24-Hour Sleep-Wake Disorder in the third quarter of 2014 were $5.2 million as compared to $1.6 million in the second quarter of 2014.

“Our innovative approach to the commercialization of Hetlioz for Non-24 has yielded impressive third quarter revenue. We are developing a robust commercial engine that has just begun to access the Non-24 market in the US by creating awareness leading to diagnosis and treatment,” says Mihael Polymeropoulos, MD, Vanda’s president and CEO, in a release. “The Named Patient Program launch in the EU and Canada under the HETLIOZAccess initiative furthers our commitment to patients with Non-24 worldwide.”

Key Highlights

  • Hetlioz US sales grew to $5.2 million in the first full quarter since launch.
  • Over 600 new patient prescriptions have been written for Hetlioz in the United States.
  • Hetlioz Marketing Authorization Application in the European Union (EU) was accepted by the European Medicines Agency (EMA) for review in June 2014; Vanda expects a regulatory decision in the third quarter of 2015.
  • In September 2014, the HETLIOZAccess Named Patient Program launched in the EU and Canada. Vanda has launched the HETLIOZAccess program in geographic locations where Hetlioz is not yet approved but where the company is pursuing regulatory approvals.
  • Vanda has initiated development activities for a pediatric formulation to be studied in pediatric patients with Non-24. Vanda has also initiated discussions with the US FDA and the EMA on clinical protocol designs for this indication.