“We are encouraged by the early positive reception of Hetlioz by patients, physicians, and payors. We look forward to more patients benefiting from Hetlioz in the coming months and years,” says Mihael Polymeropoulos MD, president and CEO of Vanda Pharmaceuticals, in a release about the company’s second quarter 2014 results.
- As of August 6, 2014, over 420 new patient prescriptions have been written for Hetlioz (tasimelteon) in the United States.
- In June 2014, Vanda announced that the European Medicines Agency (EMA) accepted for evaluation the Marketing Authorization Application for oral Hetlioz capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
- In July 2014, the US Patent and Trademark Office (USPTO) issued a new method of use patent for Hetlioz in the treatment of Non-24.
Total revenues for the second quarter of 2014 were $10.9 million, compared to $9.1 million for the first quarter of 2014 and $8.3 million for the second quarter of 2013. Net product revenues related to US sales of Hetlioz in the second quarter of 2014 were $1.6 million.
Total operating expenses for the second quarter of 2014 were $32.5 million, compared to $35.7 million for the first quarter of 2014 and $11.7 million for the second quarter of 2013. Vanda recorded a net loss of $21.6 million for the second quarter of 2014, compared to a net loss of $26.5 million for the first quarter of 2014 and $3.4 million for the second quarter of 2013.
As of August 6, 2014, over 420 new patient prescriptions have been written for Hetlioz, representing growth of approximately 90% in new prescriptions since the company’s June 4 commercial update. Hetlioz was launched in the United States in April 2014 for the treatment of Non-24, a disorder that affects the majority of totally blind individuals. It is estimated that approximately 80,000 Americans have the disorder.
On July 22, 2014, a new method of use patent was issued by the USPTO for Hetlioz in the treatment of Non-24 (patent number 8,785,492). The ‘492 patent is expected to expire in 2033, potentially further extending the exclusivity protection of Hetlioz. In the United States, Hetlioz is also covered by a composition of matter patent (patent number 5,856,529), which including a Hatch-Waxman 5-year extension is currently expected to expire in 2022. Both patents, ‘529 and ‘492, are now listed in the FDA’s Orange Book.
In June 2014, the EMA accepted for evaluation Vanda’s Marketing Authorization Application for oral Hetlioz capsules for the treatment of Non-24. Hetlioz was previously granted orphan drug designation by the European Commission for the treatment of Non-24.
Vanda has initiated development activities for the use of Hetlioz in the pediatric population with Non-24, as well as in patients with Smith-Magenis syndrome.
The VLY-686, NK1 antagonist, Phase 2 study in chronic pruritus is ongoing and results are expected in mid-2015.