201120102010Total cash and marketable securities
(2) Non-cash stock-based compensation is allocated to both Research & development and General & administrative expenses.OPERATIONAL HIGHLIGHTS First quarter 2011 sales of Fanapt® were reported by Novartis to be $9.0 million. Fanapt® prescriptions, as reported by IMS, reached 25,000 in the first quarter of 2011.
Novartis initiated a clinical study for the once a month injectable depot formulation of Fanapt® in April 2011. This is a Phase I study that will evaluate the safety and pharmacokinetic profiles of two different long-acting formulations of Fanapt® in patients with schizophrenia. A long-acting injectable formulation could offer a potential new option for patients with schizophrenia who might benefit from less frequent dosing compared to an oral medication.
Vanda expects to file for European regulatory approval of oral Fanapt® in the second half of 2011. This continues the effort to expand the availability of Fanapt® to markets outside the U.S. and Canada.
On March 31, 2011, Vanda announced plans to evaluate tasimelteon in Major Depressive Disorder. There is considerable evidence that suggests circadian rhythm disturbances are important in the pathophysiology of mood disorders. Treatment with tasimelteon would represent a novel and differentiated approach to assisting the millions of patients who suffer from the symptoms of major depression. A Phase IIb/III clinical trial will examine safety and efficacy of tasimelteon versus placebo and is expected to begin during the second half of 2011. The study will include an 8-week treatment period and an optional open-label extension.
Enrollment is ongoing in tasimelteon studies VP-VEC-162-3201 (efficacy) and VP-VEC-162-3202 (safety) in the treatment of N24HSWD in
|SOURCE Vanda Pharmaceuticals Inc.|
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