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Vanda Pharmaceuticals Reports Second Quarter 2016 Financial Results

WASHINGTON, July 27, 2016 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the second quarter ended June 30, 2016.

"Vanda's commercial business continues to demonstrate strong progress and growth," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "We look forward to our planned launch of HETLIOZ in Germany in the third quarter and the opportunity to bring an important therapy to Non-24 patients in Europe."

Key Highlights:

  • Total net product sales from HETLIOZ® and Fanapt® were $36.0 million during the second quarter of 2016, an 8% increase compared to $33.3 million in the first quarter of 2016 and a 31% increase compared to $27.6 million in the second quarter of 2015.

HETLIOZ® (tasimelteon)

  • HETLIOZ® net product sales grew to $17.5 million in the second quarter of 2016, an 8% increase compared to $16.2 million in the first quarter of 2016 and a 74% increase compared to $10.0 million in the second quarter of 2015.
  • A HETLIOZ® product launch in Germany is planned for the third quarter of 2016.
  • Enrollment in the Smith-Magenis Syndrome (SMS) open label interventional study is ongoing. An SMS placebo controlled Phase III study is expected to begin in the second half of 2016.
  • The Pediatric Non-24 pharmacokinetic study of the HETLIOZ® liquid formulation is enrolling. A Phase III study is expected to begin in 2017.
  • The screening of patients for a Jet Lag Disorder (JLD) Phase II proof of concept study began during the second quarter of 2016. Results from the JLD study are expected in the first half 2017.

Fanapt® (iloperidone)

  • Fanapt® net product sales were $18.6 million for the second quarter of 2016, a 9% increase compared to $17.1 million in the first quarter of 2016 and a 6% increase compared to $17.6 million in the second quarter of 2015.
  • In May 2016, the U.S. Food and Drug Administration (FDA) approved Vanda's supplemental New Drug Application (sNDA) for Fanapt®, modifying and expanding the prescribing information for the use of Fanapt® as a maintenance treatment for schizophrenia in adults. The FDA granted three years of marketing exclusivity for the changes related to the approval of the sNDA.
  • A review of the Marketing Authorization Application for oral Fanaptum® tablets by the European Medicines Agency (EMA) for the treatment of...

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