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Vanda Pharmaceuticals Reports Second Quarter 2014 Results
Date:8/7/2014

33 

(1) Unaudited.(2) Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer to footnote 3 in the quarterly report on Form 10Q for the quarter ending June 30, 2014.(3) Non-cash stock-based compensation is allocated to both Research & development and Selling, general & administrative expenses. (4) Total Cash reflects cash, cash equivalents and marketable securities 

OPERATIONAL HIGHLIGHTSAs of August 6, 2014, over 420 new patient prescriptions have been written for HETLIOZ® in the  U.S. This represents growth of approximately 90% in new prescriptions since the Company's June 4, 2014 commercial update.  HETLIOZ® was launched in the U.S. in April 2014 for the treatment of Non-24, a disorder which affects the majority of totally blind individuals. It is estimated that approximately 80,000 Americans have the disorder.

On July 22, 2014, a new method of use patent was issued by the USPTO for HETLIOZ® in the treatment of Non-24 (patent number 8,785,492).  The '492 patent is expected to expire in 2033, potentially further extending the exclusivity protection of HETLIOZ®. In the U.S., HETLIOZ® is also covered by a composition of matter patent (patent number 5,856,529), which including a Hatch-Waxman 5-year extension is currently expected to expire in 2022.  Both patents, '529 and '492, are now listed in the FDA's Orange Book.In June 2014, the EMA accepted for evaluation Vanda's Marketing Authorization Application for oral HETLIOZ® capsules for the treatment of Non-24.
HETLIOZ® was previously granted orphan drug designation by the European Commission for the treatment of Non-24. 

Vanda has initiated development activities for the use of HETLIOZ® in the pediatric population with Non-24, as
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SOURCE Vanda Pharmaceuticals Inc.
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