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THRX > SEC Filings for THRX > Form 8-K on 20-May-2013All Recent SEC Filings

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Other Events, Financial Statements and Exhibits

Item 8.01 Other Events.

On May 20, 2013 at the American Thoracic Society International Conference in Philadelphia, Pennsylvania, GlaxoSmithKline plc (GSK) presented posters containing information from Phase 3b studies of the combination treatment fluticasone furoate/vilanterol (FF/VI) and a Phase 3 study of the combination treatment umeclidinium bromide (UMEC)/VI. FF/VI, known in the United States as BREO™ ELLIPTA™ (100/25mcg), recently gained U.S. Food and Drug Administration approval as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm or the treatment of asthma. FF/VI remains in development elsewhere in the world for the maintenance treatment of asthma and COPD, with pending marketing authorization applications in a number of countries. It is not currently approved or licensed in the European Union or anywhere outside of the U.S. UMEC, a long-acting muscarinic antagonist, combined with VI, a LABA, is a once-daily investigational medicine for the maintenance treatment of patients with COPD. FF/VI and UMEC/VI are in development under the LABA collaboration agreement between GSK and Theravance, Inc. The posters are filed as Exhibits 99.1 to 99.2 to this report and are incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit                                    Description

Exhibit 99.1   Once-daily (OD) fluticasone furoate/vilanterol 100/25mcg (FF/VI)
               compared with twice-daily (BD) fluticasone propionate/salmeterol
               250/50mcg (FSC) in patients with COPD

Exhibit 99.2   Efficacy and safety of once-daily umeclidinium/vilanterol 125/25mcg
               in patients with COPD

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