Theravance Biopharma Highlights Positive Top-Line Results From Pivotal Phase 3 FULFIL Study of the Closed Triple Announced by GlaxoSmithKline and Innoviva - Seite 2

Additional top-line FULFIL study results announced by GSK and Innoviva include:

• Most common adverse events across both treatment arms at 24 and 52 weeks were nasopharyngitis, headache and COPD worsening.
  
  
• At 24 weeks, the incidence of investigator-reported serious adverse events was 5.4% and 5.7% for FF/UMEC/VI and budesonide/formoterol, respectively. This included worsening of COPD (1.3% and 2.3%); pneumonia (1.0% and 0.3%); and cardiac disorders (0.3% and 1.0%), respectively.
  
  
• At 52 weeks, the incidence of investigator-reported serious adverse events was 10.0% for FF/UMEC/VI and 12.7% for budesonide/formoterol, respectively. This included worsening of COPD (2.4% and 9.1%); pneumonia (1.9% and 1.8%); and cardiac disorders (1.4% and 0.9%), respectively.
  
  

The Closed Triple combination therapy represents a unique approach to COPD treatment by seeking to combine the activity of three molecules with different mechanisms of action in a single delivery device. The combination treatment includes: fluticasone furoate (FF), an inhaled corticosteroid; umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (VI), a long-acting beta₂-adrenergic agonist (LABA). This combination has been formulated to be delivered once-daily in GSK's Ellipta^® dry powder inhaler.

The FULFIL study compared FF/UMEC/VI with budesonide and formoterol, an ICS/LABA combination delivered twice-daily in the Turbohaler dry powder inhaler. GSK and Innoviva intend to submit full results from the FULFIL study, including data from secondary endpoints and the 52-week extension study, for presentation at a scientific congress.

In addition to the FULFIL study, the ongoing clinical development program for the Closed Triple in COPD includes the IMPACT study, a second Phase 3 trial designed to evaluate the effectiveness and safety of the combination treatment compared to existing COPD therapies. Results of the IMPACT study are expected in 2017¹.

Notes:
¹Regulatory and clinical milestones as reported by Glaxo Group Limited or one of its affiliates (GSK)

About Theravance Biopharma

Theravance Biopharma is a diversified biopharmaceutical company with the core purpose of creating medicines that make a difference in the lives of patients suffering from serious illness. Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV^® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop GI-targeted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases.