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Vanda
Pharmaceuticals (VNDA) has three product candidates in clinical development for
various central nervous system disorders. Lead product candidate,
iloperidone, is a compound for the treatment of schizophrenia and
bipolar disorder. VEC-162, a treatment of sleep and mood disorders, VSF-173,
a compound for excessive sleepiness. Now in Phase 2 trial.
Announcements
May 1, 2007
Expecting a net loss in fiscal 2007
to be between $110-$120 million, or approximately $(4.18)-$(4.56) per share.
According to Reuters Estimates analysts were expecting the Company to report EPS of $(2.52) for fiscal 2007.
April 25, 2006
Initiating a Phase 2 clinical trial of its product candidate VSF-173 in
excessive sleepiness (ES). The randomized, double-blind, placebo-controlled
study will investigate the safety and efficacy of three oral doses of VSF-173 for the treatment of induced excessive
sleepiness. Candidates: Healthy volunteers. Number of candidates: 60. Gender : males and females.
Primary endpoint: The difference from placebo on the Maintenance of Wakefulness Test
(MWT), a standard measure of sleepiness.
January
19, 2007
Announcement
of offering of 3,800,000 shares of common stock at a price to the public of
$27.29 per share. All of the shares are offered by the company and are newly
issued. Net proceeds to the
Company: Approximately
$96.2 million after
deducting underwriting discounts and commissions and estimated offering expenses. The
joint book-running managers for the offering: JPMorgan and Morgan
Stanley. Co-managers: Banc of America Securities
LLC and Natexis Bleichroeder Inc.
December
07, 2006
Phase 3 clinical trial results of iloperidone, an atypical antipsychotic for schizophrenia, demonstrated statistically significant improvement compared to placebo on the Positive and
Negative Symptom Scale (PANSS). Safety was consistent with what has been observed in
previous iloperidone Phase 3 trials.
Iloperidone's efficacy
and safety in patients with specific genetic profiles: Vanda had previously identified a polymorphism in
a gene, occurring in approximately 70% of patients, hypothesized to be
associated with the pathogenesis of schizophrenia, which appeared to correlate
with iloperidone response. Iloperidone achieved statistical significance vs.
placebo on the PANSS scale in these patients, with a magnitude of response
greater than that seen in the overall iloperidone population.
November 2006
VEC-162
demonstrated significant improvement in several parameters used to measure the
efficacy of insomnia therapies, including reduced duration of wake after sleep
onset, improved sleep efficiency and shortened time to persistent sleep.
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