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Anoro Ellipta

Treatment for Chronic Obstructive Pulmonary Disease

Update: Anoro Ellipta Now FDA Approved - December 18, 2013

FDA Advisory Committee to Review Anoro Ellipta NDA

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 09/10/13 -- Theravance,Inc. (NASDAQ: THRX) today announced that NASDAQ halted trading of Theravance common stock this morning, September 10, 2013. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) meets today to discuss the new molecular entity New Drug Application (NDA) 203975 for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO™ ELLIPTA™), sponsored by Glaxo Group (d/b/a GSK) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. 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. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance's key programs include: RELVAR™ ELLIPTA™ or BREO™ ELLIPTA™ (FF/VI), ANORO™ ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance's web site at www.theravance.com.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of the brand names ANORO™ and RELVAR™ has not yet been approved by any regulatory authority.

(THRX-G)

Contact Information:

Michael W. Aguiar

Senior Vice President and Chief Financial Officer

650-808-4100

investor.relations@theravance.com

Source: Theravance, Inc.

 

Posted: September 2013

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