Business Context and Reporting Period
This Form 6-K filing by GlaxoSmithKline plc (GSK) covers the period ending September 11, 2017. The report details the publication of positive results from the Salford Lung Study (SLS) in asthma, published in The Lancet and presented at the European Respiratory Society International Congress. The study was conducted in collaboration with Innoviva, Inc.
Key Financial Metrics
The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This document is a current report focused on clinical study results rather than a financial statement.
Material Changes and Clinical Results
The primary material update is the successful outcome of the Salford Lung Study, a Phase III multi-centre, open-label randomised controlled trial involving 4,233 patients. Key findings include:
- Asthma Control: Initiation of Relvar Ellipta (fluticasone furoate/vilanterol) was superior to usual care. At 24 weeks, 71% of patients on Relvar Ellipta achieved better asthma control compared to 56% on usual care (Odds Ratio 2.00; p<0.001).
- Quality of Life: Patients on Relvar Ellipta showed statistically significant improvements in Asthma Quality-of-Life Questionnaire (AQLQ) scores compared to usual care.
- Work and Activity: Relvar Ellipta resulted in a greater decrease in work impairment (-6.7% vs. -4.0%) and activity impairment (-10.4% vs. -5.9%) compared to usual care.
- Rescue Medication: The number of salbutamol inhalers used was significantly lower in the Relvar Ellipta group (difference -0.8; p<0.0001).
- Exacerbations: There was a numerical 2% reduction in asthma exacerbations for Relvar Ellipta versus usual care, but this difference was not statistically significant (p=0.6969).
- Safety: The incidence of serious adverse events was identical in both arms (13%). The safety profile was consistent with the product label.
Guidance, Outlook, and Risks
Management Commentary: GSK and Innoviva leadership highlighted the study as a pioneering tool for assessing medicine effectiveness in everyday clinical practice. The results demonstrate a meaningful impact on the daily lives of patients managing asthma.
Risks and Contingencies:
- Forward-Looking Statements: GSK and Innoviva caution that projections regarding the use of study data and potential benefits are subject to risks and uncertainties that may cause actual results to differ materially.
- Safety Warnings: The filing reiterates standard safety warnings for Relvar Ellipta (Breo Ellipta in the U.S.), including contraindications for acute asthma symptoms, risks of pneumonia (particularly in COPD patients), and potential cardiovascular effects. Long-acting beta2-adrenergic agonists (LABA) carry a risk of asthma-related death.
Investor Verification Checklist
- Verify the commercial impact of the Salford Lung Study results on Relvar Ellipta/Breo Ellipta sales projections.
- Review the full safety data regarding pneumonia incidence in asthma patients at higher doses (184/22mcg) as noted in the prescribing information.
- Confirm the royalty revenue structure between GSK and Innoviva regarding the respiratory assets.
- Assess the statistical significance of the non-significant findings regarding asthma exacerbations and primary care contacts.