Vanda Pharmaceuticals’ Hetlioz Shows Promise for Treating Jet Lag

Published: Mar 05, 2018 By

Jet Lag

Vanda Pharmaceuticals, Inc., based in Washington, D.C., announced positive results from its JET8 Phase III clinical trial of Hetlioz for jet lag disorder.

Jet lag disorder is common in people who cross multiple time zones during travel. It is characterized by nighttime sleep disruption, problems with staying alert during the day and problems in social and occupational functioning.

In the study, 318 healthy volunteers reported to a sleep research unit and were basically put to bed, what they call a circadian challenge, eight hours ahead of their usual bedtime. This is comparable to crossing eight time zones. It also, the company stated, allowed them to study the drug “without the confounding effects of sleep deprivation and variable light conditions.”

The primary endpoint was the amount of sleep time in the first two thirds of the night. Secondary endpoints were various sleep parameters, TST, LPS, WASO and next day alertness, KSS and VAS. The total sleep time benefit magnitude was 85 minutes’ improvement over placebo. It also showed improvements in next day alertness for KSS and VAS.

The drug had already shown positive effects in the JET5 trial, which was a five-hour challenge, and results were published in The Lancet in 2009. Between these two studies, the drug appears effective in treating the symptoms of jet lag in a magnitude of five to eight hours.

“We are extremely pleased with the outcome of this study which establishes the utility of Hetlioz in the treatment of jet lag disorder as Hetlioz was shown to overcome a significant circadian challenge of an eight-hour phase advance,” said Mihael Polymeropoulos, Vanda’s president and chief executive officer, in a statement. “This challenge is equivalent to eastward travel across eight time zones as experienced, for example, on travel from Los Angeles to London, Washington, D.C. to Moscow, Paris to Tokyo, or London to Singapore. Hetlioz improved both nighttime sleep and next day alertness potentially offering significant benefits to millions of travelers.”

Hetlioz is already approved in the U.S. and Europe for non-24-hour sleep-wake disorder, a rare and chronic circadian rhythm sleep disorder.

On February 14, the company released its fourth-quarter financials. Total net product sales from Hetlioz and Fanapt were $44.3 million for the quarter, up 7 percent compared to $41.3 million in the third quarter and a 16 percent increase compared to $38.2 million in the fourth quarter of 2016. Total revenues for the year were $165.1 million, compared to $146.0 million in 2016.

Jefferies Group has given the company a “buy” rating and a $20 price target for the stock. Its estimates for the company’s 2019 earnings are $0.81 EPS, but ($0.06) for this quarter.

Shares opened on Friday, March 2 at $19, and had a 52-week low of $11.90 and a 52-week high of $19.70. Its market cap is $863.32 million.

Dispatch Tribunal noted, “Several hedge funds and other institutional investors have recently added to or reduced their stakes in Vanda. Teacher Retirement System of Texas acquired a new stake in shares of Vanda Pharmaceuticals during the fourth quarter valued at $209,000. Metropolitan Life Insurance Co. NY acquired a new stake in shares of Vanda Pharmaceuticals during the fourth quarter valued at $221,000. Los Angeles Capital Management & Equity Research Inc. acquired a new stake in shares of Vanda Pharmaceuticals during the third quarter valued at $277,000. MetLife Investment Advisors LLC acquired a new stake in shares of Vanda Pharmaceuticals during the fourth quarter valued at $308,000. Finally, Voya Investment Management LLC boosted its holdings in shares of Vanda Pharmaceuticals by 29.7 percent during the second quarter.”

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