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Glaxosmithkline (GSK), Theravance (THRX) Submit MAA In Europe For UMEC/VI

 January 09, 2013 07:32 AM

(By Balachander) GlaxoSmithKline Plc (NYSE: GSK) and Theravance Inc. (NASDAQ: THRX) announced the submission of a regulatory application in the European Union for UMEC/VI as a treatment for patients with chronic obstructive pulmonary disease (COPD).

A Marketing Authorisation Application (MAA) for UMEC/VI (55/22mcg and 113/22mcg doses), with the proposed proprietary name ANORO, has been submitted to the European Medicines Agency (EMA), the companies said.

UMEC/VI 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 inhaler.

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The companies plan regulatory submissions for UMEC/VI in other countries during the course of 2013.

Further, GSK said it plans to commence global regulatory submissions for UMEC monotherapy later this year.

UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR and BREO), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK's investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab).

THRX shares ended at $21.72, while U.S.-listed shares of GSK closed at $44.27 on Tuesday.

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