LONDON, UK and SOUTH SAN FRANCISCO, CA, USA I August 6, 2015 I GSK (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) announce the approval in Canada of BREO® ELLIPTA® (fluticasone furoate/vilanterol dry powder for oral inhalation) for the once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease.

BREO® ELLIPTA® is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol. Two strengths, 100/25 mcg and 200/25 mcg, have been approved in Canada for use in asthma. BREO® is administered once daily via the dry powder inhaler called ELLIPTA®, which is also used across a range of other approved respiratory medicines in the GSK portfolio.

Sally Taylor, Country Medical Officer, Canada said: “BREO® ELLIPTA®, a GSK asthma treatment approved in Canada now provides physicians with a once-daily treatment option delivered via the ELLIPTA® inhaler to meet the needs of appropriate adult patients.”

Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc., said: “With today’s approval of BREO® ELLIPTA® in Canada, we are pleased to expand the number of patients able to benefit from this important medicine. As a once-daily ICS/LABA treatment for adults with asthma, people suffering from this chronic condition now have an additional option.”

Please consult the Product Monograph that will be posted at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

BREO® and ELLIPTA® are trademarks of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.

About Asthma

Asthma is a chronic lung disease that inflames and narrows the airways.1 Approximately 2.5 million people in Canada currently have asthma.2 Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.3

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

References

1. Global Initiative for Asthma. Pocket Guide for asthma management and prevention. Updated 2014.

2. Statistics. Canada. 2015

3. ODPRN Report: Inhaled Corticosteroids (ICS) + Long-Acting Beta Agonists (LABA) in the Treatment of Asthma “Final Consolidated Report” Apr 1st, 2015

GSK — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For information, please visit www.gsk.com.

Theravance, Inc. — is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Theravance’s portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Theravance and GSK. Under the agreement with GSK, Theravance is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, if approved and commercialized, VI monotherapy, as well. In addition, Theravance retains a 15% economic interest in future payments made by GSK for earlier-stage programs under the agreements with GSK. For more information, please visit Theravance’s website at www.thrxinc.com.

SOURCE: Theravance