Theravance Announces FDA Advisory Committee to Review BREO(R) ELLIPTA(R) (FF/VI) for Asthma

SOUTH SAN FRANCISCO, CA--(Marketwired - Feb 6, 2015) -  Theravance, Inc. (NASDAQ: THRX) today announced that on March 19, 2015, the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss the supplemental New Drug Application (NDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO^® ELLIPTA^®), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older. The advanced display of the Federal Register notice announcing the advisory committee meeting can be found at: http://www.ofr.gov/OFRUpload/OFRData/2015-02554_PI.pdf

BREO^® ELLIPTA^® is a fixed dose combination of the inhaled corticosteroid, fluticasone furoate (FF) and the long-acting beta₂ agonist (LABA), vilanterol (VI), administered using the ELLIPTA^® inhaler. The Prescription Drug User Fee Act (PDUFA) goal date is April 30, 2015. FF/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.

About Theravance

Theravance, Inc. is focused on maximizing the potential value of the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR^®/BREO^® ELLIPTA^® and ANORO^® ELLIPTA^®, with the intention of providing capital returns to stockholders. Under the Long-Acting Beta₂ Agonist (LABA) Collaboration Agreement with GSK, Theravance is eligible to receive the associated royalty revenues from RELVAR^®/BREO^® ELLIPTA^® (fluticasone furoate/vilanterol, "FF/VI"), ANORO^® ELLIPTA^® (umeclidinium bromide/vilanterol, "UMEC/VI") and if approved and commercialized, VI monotherapy. Theravance is also entitled to a 15% economic interest in any future payments made by GSK under agreements entered into prior to the spin-off of Theravance Biopharma, and since assigned to Theravance Respiratory Company, LLC, relating to the combination of UMEC/VI/FF and the Bifunctional Muscarinic Antagonist-Beta₂ Agonist (MABA) program, as monotherapy and in combination with other therapeutically active components, such as an inhaled corticosteroid, and any other product or combination of products that may be discovered and developed in the future under these agreements with GSK (other than RELVAR^®/BREO^® ELLIPTA^®, ANORO^® ELLIPTA^® and VI monotherapy). For more information, please visit Theravance's website at www.thrxinc.com.