Item 8.01. Other Events

On February 19, 2013, GlaxoSmithKline plc (GSK) and Theravance, Inc. (Company) issued a press release announcing that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as December 18, 2013. GSK and Theravance also announced that the Marketing Authorization Application (MAA) for UMEC/VI for COPD has been validated for assessment by the European Medicines Agency (EMA). UMEC/VI, with proposed brand name ANORO(TM), is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA(TM) inhaler. UMEC/VI is in development under the LABA collaboration between GSK and the Company. A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits

(d) Exhibits
99.1 Press Release of Theravance, Inc. dated February 19, 2013

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