SOURCE: Theravance, Inc.

Theravance, Inc.

April 17, 2013 07:05 ET

Trading in Theravance Common Stock Halted

FDA Advisory Committee to Review BREO™ ELLIPTA™ NDA

SOUTH SAN FRANCISCO, CA--(Marketwired - Apr 17, 2013) - Theravance, Inc. (NASDAQ: THRX) today announced that NASDAQ halted trading of Theravance common stock this morning, April 17, 2013. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) meets today to discuss the new drug application (NDA) 204275, for fluticasone furoate (FF) and vilanterol (VI) dry powder inhaler (proposed trade name BREO™ ELLIPTA™), sponsored by GlaxoSmithKline plc (GSK), for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. FF/VI, an investigational once-daily inhaled corticosteroid/long-acting beta2 agonist (LABA) combination treatment, is in development under the LABA collaboration between GSK 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™ 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

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

RELVAR™ or BREO™ ELLIPTA™ (FF/VI) and ANORO™ ELLIPTA™ (UMEC/VI) are investigational medicines and are not currently approved anywhere in the world. RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of these brand names has not yet been approved by any regulatory authority.


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