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Vanda Pharmaceuticals Reports Third Quarter 2010 Results
Date:11/3/2010

>

0.11

0.05

0.06

120%Diluted net income per share attributable to common stockholders

0.11

0.04

0.07

175%Total cash and marketable securities

202,060,000

207,117,000

(5,057,000)

-2%(1)  Unaudited

OPERATIONAL HIGHLIGHTS   Year-to-date net sales of Fanapt® were reported by Novartis to be approximately $26.3 million, comprised of $20.7 million in the first quarter of 2010, $0.7 million in the second quarter of 2010 and $4.9 million in the third quarter of 2010.  Vanda is encouraged by the continuing growth in the total number of monthly prescriptions, as reported by IMS. According to IMS, monthly prescriptions of Fanapt® increased from over 4,000 in June of 2010 to over 6,000 in September of 2010.

The development of the iloperidone depot formulation is ongoing with Vanda retaining the rights for commercialization outside the U.S. and Canada.  On October 28, 2010, the U.S. Patent and Trademark Office (USPTO) informed Vanda that it has granted an additional patent term adjustment of 59 days, making the total extension 664 days and making the patent expiration date August 25, 2023.

Vanda continues to explore the regulatory path and commercial opportunity for Fanapt® oral formulation outside of the U.S. and Canada.  On November 1, 2010, Australia's Department of Health and Ageing -- Therapeutic Goods Administration, accepted for evaluation Vanda's application for marketing approval.

Enrollment has begun in Study VP-VEC-162-3201, a 160-patient randomized controlled trial of tasimelteon versus placebo in the treatment of Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception. Top-line results are expected in late 2011. The trial has a 6-month treatment period and includes measures of both nighttime and daytime sleep, as well as laboratory measures of the synchronization between the inte
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SOURCE Vanda Pharmaceuticals Inc.
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3. Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
4. Vanda Presents Phase III Iloperidone Efficacy Data
5. Phase III Data Show Vanda Pharmaceuticals Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia
6. Vanda Pharmaceuticals Provides Update on Iloperidone
7. Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet
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11. Vanda Pharmaceuticals Announces U.S. Patent Allowance for a Long-Acting Injectable Formulation of Fanapt(TM) (iloperidone) in the U.S.
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