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THRX > SEC Filings for THRX > Form 8-K on 9-Dec-2013All Recent SEC Filings

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Form 8-K for THERAVANCE INC


9-Dec-2013

Other Events


Item 8.01 Other Events.

On December 9, 2013, GlaxoSmithKline plc (GSK) and Theravance, Inc. announced the launch of RelvarŽ ElliptaŽ, the first once-daily ICS/LABA medication for asthma in Japan. Relvar Ellipta is indicated for bronchial asthma (in the case where concurrent use of inhaled corticosteroid (ICS) and long-acting inhaled beta2 agonist (LABA) is required). The launch follows the recent approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) on September 20, 2013. Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2 agonist (LABA), vilanterol "VI" (FF/VI). Two strengths of FF/VI have been approved for the treatment of asthma, 100/25 mcg and 200/25 mcg, and will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI). Relvar Ellipta has been developed under the collaboration agreement between Glaxo Group Limited and Theravance, Inc. Theravance, Inc. is obligated to make a milestone payment of $10 million (USD) to GSK following the launch of Relvar Ellipta in Japan.


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