Not everyone is lucky enough to enjoy the life’s simple pleasure, a good night’s sleep.
It is estimated that at least 40 million Americans suffer from chronic or long-term sleep disorders, and an additional 20 million experience occasional sleeping problems. Obstructive sleep apnea, insomnia, restless legs syndrome and narcolepsy are some of the most common sleep disorders.
A chronic and little-known sleep dysfunction, mostly observed in blind people, is non-24-hour sleep-wake disorder, also known as N24HSWD, which results in symptoms of insomnia and/or excessive sleepiness.
This debilitating circadian rhythm sleep disorder affects individuals who are unable to synchronize their internal body clock to the standard 24-hour light-dark cycle, and therefore they do not necessarily associate night with sleep, and day with being awake. The chronic sleep deprivation due to N24HSWD may lead to impairment in daily functioning, social interactions, school and work performance, and increases the risk for accidents.
Currently, there are no approved medications for N24HSWD. Developing a drug intended to treat N24HSWD and other circadian rhythm sleep disorders is Vanda Pharmaceuticals Inc. (VNDA).
For readers who are new to Vanda, here’s a brief overview of its pipeline and the upcoming events to watch out for…
The most advanced compound in the company’s pipeline is Tasimelteon, a circadian regulator, which is being evaluated in two phase III efficacy studies, dubbed SET and RESET, for non-24-hour sleep-wake disorder in totally blind individuals with no light perception.
Vanda expects top-line results from the SET study to be announced by the end of 2012 and RESET study results in the first quarter of 2013.
The SET study, which enrolled 84 patients with N24HD, has a six-month treatment period with Tasimelteon. The trial is designed to evaluate both nighttime and daytime sleep, as well as laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle.
The RESET trial is a 12-week, withdrawal study of 20 patients with N24HD to examine the maintenance effect of Tasimelteon in the treatment of N24HD.
Although non-24-hour sleep-wake disorder can affect sighted people also, it is mostly seen in people who are totally blind and who don’t have sensitivity to light. It is estimated that 50% of totally blind people in the U.S., or approximately 65,000 people, suffer from this sleep condition. Vanda estimates the total worldwide market potential of Tasimelteon in the indication of non-24-hour sleep-wake disorder at $500 million.
The company is also testing Tasimelteon for the treatment of Major Depressive Disorder, or MDD. A phase IIb/III trial in the indication of MDD, dubbed MAGELLAN-2301, was initiated in Q3, 2011. This trial is fully enrolled and top-line results are expected in the first quarter of 2013.
Also in the pipeline is VLY-686, a phase II ready program, which was licensed from Eli Lilly & Co. (LLY) in April 2012.
VLY-686 is a small molecule neurokinin 1 receptor (NK-1R) antagonist that can be evaluated in a number of indications including, chemotherapy-induced nausea and vomiting (CINV), post-operative nausea and vomiting (PONV), alcohol dependence, anxiety, depression and pruritus.
Vanda has one FDA-approved oral drug – Fanapt, to treat schizophrenia, which has been available since January 2010. The drug is marketed in the U.S. and Canada by Novartis AG (NVS), and Vanda receives royalty payments from Novartis on net sales in those countries. Vanda received royalty revenue of $3.1 million in 2010; $4.5 million in 2011 and $4.77 million in the first nine months of 2012, based on net sales of Fanapt.
A phase II trial with long-acting injectable formulation of Fanapt was initiated by Novartis in April 2011. However, last month, Novartis discontinued development on the long-acting injectable formulation.
Outside of the U.S. and Canada, Vanda has full commercial rights for Fanapt. Vanda’s commercial partner for Fanapt is Biotoscana Farma S.A in Argentina; Megapharm Ltd. in Israel and Probiomed S.A. de C.V in Mexico.
Vanda’s Marketing Authorization Application for oral Fanapt is under review in the European Union. Fanapt was granted market approval in Israel and Argentina very recently this year.
A quick look at the company’s balance sheet…
Since inception in 2003, Vanda has incurred significant losses, and at September 30, 2012, had an accumulated deficit of $284.7 million.
In Q3, 2012, the company’s net loss widened to $5.3 million or $0.19 per share from $3.1 million or $0.11 per share in the year-ago comparable quarter. Total revenues, including Fanapt royalties, in the third quarter of 2012 were $8.3 million, compared to $8.0 million for the same period in 2011.
The company ended Q3, 2012 with $104.5 million in cash and cash equivalents.
Vanda went public in April 2006, offering its shares at $10 each. The stock has thus far hit a 52-week low of $3.12 and a 52-week high of $5.47. VNDA closed Wednesday’s trading at $3.14, down 0.95% on a volume of 106 thousand shares.
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