Committed to a brighter future forpeople with respiratory disease

GSK Respiratory

Contents

Committed to respiratory research & development

05

A history of treatment advancement

06

Recognising needs

09

Spearheading landmark clinical trials

10

Changing the way we work with you

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Continuous innovation in respiratory inhalers

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On a mission to make a difference

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ImpactFirst

Development Foundation

Patients

Alliance

Social responsibility

HealthcareLeadership

Patient-centred

ResearchImportant

ContributionResponsible

Professional

Partnerships

Leaders

SupportTherapy

Innovation

Community

Access

MissionImprove

Susta inabi l i t y

Medicines

InitiativeHeritage

Supporting patients and healthcare professionals

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Advancing science

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1. Rapier World Dec-2014 Model2. World Health Organization. Non-Communicable Diseases. Fact Sheet. March 2013. Available at: http://www.who.int/mediacentre/factsheets/fs355/en/ [Last accessed: July 2015].

We provide around one third of medicines used by patients with asthma and COPD worldwide1

Committed to respiratory research & developmentAs an organisation, GSK’s mission is to improve the quality of human life by enabling patients to do more, feel better and live longer. We place the patient at the heart of everything we do and as leaders in respiratory disease we are committed to improving the lives of those living with asthma, COPD and other respiratory-related illnesses such as pulmonary arterial hypertension (PAH).

We are constantly striving to expand knowledge and the understanding of respiratory disease to help revolutionise the way that medicines are developed. We are focused on identifying new scientific insights, applying our expertise and developing innovative new medicines that enable clinicians to tailor treatment to patients’ individual needs.

£3.5 billioninvested in R&D each year to explore new areas of scientific research and maximise the benefits we can pass on to patients with respiratory disease.

Ranked No.1in the Access to Medicines Index – an independent barometer of pharmaceutical companies’ efforts to make their products accessible and affordable to people in developing countries.

4.2 milliondeaths are caused by respiratory disease each year. That’s why we are committed to innovation and science.2

Over 40 yearsof investment in respiratory research – developing medicines that have transformed the treatment of respiratory disease.

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Over recent decades the therapeutic landscape has seen many positive developments for patients living with respiratory disease. We are proud to have been at the forefront of many of the advances in this area.This has been driven by our continued commitment to helping people with respiratory disease achieve the best possible clinical outcomes.

Our medicines have helped millions of patients worldwide with asthma and COPD.They have redefined the way in which patients with respiratory disease are managed, helping people in over 170 countries benefit from better treatment.

Our research has contributed to the development of international treatment guidelines and continues to set new standards for treatment goals for patients.

A history of treatment advancement

1970 1980 1990 2000 2010 2020

First selective SABA for asthma

First ICS/LABA combination for asthma

Novel multi-dose dry powder inhaler

ICS/LABA combination launched for COPD and asthma

First intranasal corticosteroid for allergic rhinitis

Innovative intranasal device for allergic rhinitis

Intranasal corticosteroid spray launched for allergic rhinitis

LABA launched for asthma

First ICS for asthma

ICS/LABA combination launched for COPD

First multi-unit dose DPI – innovative design ensured precise dose delivery every time

First pharmaceutical company to use dose counters on its metered dose inhalers

LAMA/LABA combination launched for COPD

LAMA launched for COPD

ICS launched for asthma

1969 1975 1998

2013

1990

2008

2014

1972mid 1980s mid

2000s

2003

Approved indications and product labels may vary in different countries.

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3. Dermoly P et al. Repeated cross-sectional survey of patients-reported asthma control in Europe in the past 5 years. Eur Respir Rev. 2012; 21:66-24

4. EFA. Book on COPD in Europe. Sharing and Caring. 2009. Available at: http://www.efanet.org/documents/EFACOPDBook.pdf.

5. Jones P et al. Health-related quality of life in patients by COPD severity with primary care in Europe. Respir Med. 2011; 105:57-66

While patients have and continue to benefit from advances in the way respiratory disease is managed, unmet clinical needs remain. • 4.2 million deaths are caused by respiratory

disease globally each year.2

• More than half of patients continue to have poor control of their asthma.3

• COPD remains under-diagnosed and under-treated.4

• The ability to carry out routine activities is limited in 74% of those with moderate COPD.5

Recognising needs

This places a significant burden not only on patients and their families, but also on healthcare professionals and healthcare systems.

We recognise that there is still much more to be achieved to overcome the global burden of respiratory disease.

Through on-going scientific research in new and existing areas and external partnerships, we will continue to innovate in the development of medicines and inhalers that have real value to patients and physicians.

Only through this commitment and scientific leadership can we help transform the lives of patients, enabling them to live longer and be healthier.

Respiratory disease can impact on many aspects of life

Daily activity

Work

Friends

Happiness and wellbeing

Family

Hobbies

Long-term health

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Randomised controlled trials play a crucial role in helping us to evaluate the efficacy and safety of medicines. However, due to their highly controlled nature, and the highly selected patient populations involved in such trials, this can also limit our ability to understand how a drug will work in real people in the real world.

To gain a better understanding of how our medicine FF/VI may affect the clinical outcomes of patients with asthma and COPD in real life, regardless of disease severity or co-morbidities, we initiated the innovative Salford Lung Study (SLS).

SLS is unique in that it is the first large, prospective, pragmatic real world study to be initiated on a pre-licence medicine. It is being conducted in one geographic location, and is a collaboration between local healthcare providers, medical informatics, academia and GSK, making the Salford Lung Study a world first.

This innovative study has been designed to mimic the real-world usage of the medicine, with real-time safety monitoring so patients experience minimal interventions. The study uses electronic health records to capture real-time data and assess the impact on healthcare utilisation.

We hope this study will provide us and the wider scientific community with a greater insight into how patients behave and respond to medical interventions in the real world and potentially alter the way that respiratory disease is managed in the future.

Spearheading landmark clinical trials

We continue to invest in research to advance our understanding of disease, gain greater insight into patients’ individual needs and develop more targeted treatments.

ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints): An ongoing non-interventional study to determine the underlying mechanisms of disease in COPD patients and identify biomarkers that may act as surrogate endpoints and measures of disease progression.8

SUMMIT (Study to Understand Mortality and Morbidity): This trial is the first prospective study to evaluate the effect of a COPD medication, fluticasone furoate and vilanterol (FF/VI), on the survival of patients with co-existing COPD and either cardiovascular disease or CVD risk factors.9

Our science and clinical trials have helped redefine the treatment landscape for respiratory patients. Our research has contributed to the development of clinical practice guidelines and helped establish new international treatment standards.

TORCH (Towards a Revolution in COPD Health): The first and largest study to investigate the potential of an ICS and a LABA to impact survival in COPD patients; the results informed the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) strategy document.6

GOAL (Gaining Optimal Asthma Control): The first prospective study to raise treatment expectations in asthma by suggesting total asthma control could realistically be achieved.7

6. Calverley P et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. NEJM 2007; 356(8): 775-89.

7. Bateman E et al. Can Guideline-defined Asthma Control Be Achieved? The Gaining Optimal Asthma Control Study. Am J Respir Crit Care Med. 2004; 170: 836–44.

8. Vestbo J et al. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008; 31(4): 869-73.

9. Vestbo J et al. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Resp J. 2013; 41(5): 1017-22.

10. Herland K et al. How representative are clinical study patients with asthma or COPD for a larger ‘‘real life’’ population of patients with obstructive lung disease? Respir Med. 2005; 99: 11-19

RCT

SLS

Very few patients in the real world meet the inclusion criteria for typical respiratory randomised controlled trials (RCTs):10

• 3% of asthma patients• 7% of COPD patients

“ The Salford Lung Study is a major advance in the way we do clinical trials. [It’s] all about real world outcomes and real people”.

- Prof Martin Gibson, National Institute for Health Research

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By inviting patients to take part in research, we are able to build on current technology to continue to develop exciting, easy-to-use inhalers that meet patients’ needs and may help improve respiratory disease management.

Continuous innovation in respiratory inhalers

Alongside the development of new medicines for respiratory disease, we continue to innovate the inhalers we use to deliver them, winning multiple design and engineering awards in the process.

We have supplied more than 1 billion DISKUS® inhalers to date.

Patient CentricityUnderstanding real needs through patient involvement in the design of new inhaler devices.

Commitment to Design ExcellenceDevelopment of our Diskus inhaler took a team of 45 dedicated researchers 8 years to bring it from concept to market.

AwardsDISKUS/ACCUHALER® INHALER

International Society of Pharmaceutical Engineering Award

UK Design Council, Millennium Product Status

Queen’s Award for Technological Achievement

US Medical Design Excellence Awards, Finals Shortlist

SIDE-ACTUATED INTRA-NASAL SPRAY

Prix Galien Award 2009

US Medical Design Excellence Awards, Winner

Our Complete the Cycle scheme is the first recycling and recovery scheme for all respiratory inhalers.

By working together with patients, pharmacists and healthcare professionals worldwide we aim to move towards a more environmentally sustainable treatment of respiratory disease.

Patient preference studies, as well as handling studies, are central to the development of any new inhaler, ensuring that the end product is something that is easy to use, receives high levels of patient satisfaction and satisfies the technical requirements for consistent, error-free dispensing of medicines.

We believe it’s imperative to keep the needs of the patient in mind from the beginning and throughout the design process and listen to user feedback so we can continuously improve.Our Ellipta® inhaler has been designed to improve on the current standard for inhalers and builds upon the expertise and heritage of the Diskus inhaler. It has been developed to enable once daily dosing across a portfolio of medicines in a single inhaler type.

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The first personalised health mobile app, designed to help patients address the four key areas of asthma control. This free app provides tips, information and monitoring tools to help patients take control of their condition and supports them to work with their healthcare professional to improve their health outcomes. www.myasthma.com

My Asthma

Asthma Control Test (ACT)

A clinically validated tool for healthcare professionals and patients to assess asthma control. Developed by Quality Metric and endorsed by asthma guidelines and professional/patient groups around the world. www.asthmacontroltest.com

COPD Assessment Test (CAT)

The only validated, short and simple assessment questionnaire for patients and healthcare professionals to assess COPD control. The test is available online at www.catestonline.org

With the future in mind we are also supporting the next generation of lung scientists and research clinicians achieve excellence in respiratory research through various initiatives including the Romain Pauwels Research Award, which is designed to support young researchers with proven excellence in clinical research further their work in this area.

Supporting patients and healthcare professionalsWe have invested in developing a range of practical tools aimed at both patients and healthcare professionals to optimise the clinical management and treatment experience of respiratory patients.

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Changing the way we work with you

Every person is different, so it is important that when thinking about disease management, each patient is treated as an individual. Nobody knows your patients like you do. Nobody knows our medicines and vaccines like we do.

We have an important role to play in supporting education for healthcare professionals. But we also recognise that some practices – such as directly funding education, paying healthcare professionals to speak about our medicines or funding travel to meetings – may leave room for perceived bias or conflict of interest.

This is why we are changing the way we work with healthcare professionals – to ensure that all our interactions are as open and transparent as possible, whilst also continuing to offer our support.

We are committed to facilitating scientific exchange and debate, and the ethical and responsible commercialisation of medicines to support our mission to improve the quality of human life by enabling people to do more, feel better, and live longer.

Our goal is to provide high quality, balanced and objective information when, where and how it is needed and most valuable.

We want to continue to be a company driven by science, which always put the needs of the patient first.

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Creating a sales force focused on the patientInstead of individual sales targets, our sales representatives will be evaluated and rewarded for their technical knowledge and the quality of the service they deliver to healthcare professionals to support improved patient care.

Changing our relationship with the medical professionWe are the first company to begin phasing out payments to doctors to speak about our products.

We are changing the way we engage with doctors and improving how we provide information about our products.

We are committed to ensure prescribers can access the information they need in the manner most convenient to them – face-to-face or online.

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On a mission to make a difference

Betty has COPDShe only has 25% lung capacity. This means she finds even everyday tasks difficult, but medicines and inhaled oxygen allow her to live as normal a life as she can.

Betty’s mindset is to stay busy and active, so every week she goes to rehab exercise classes.

We are working hard to develop tomorrow’s medicines and find new ways to get them to everyone who needs them, irrespective of where they live and their ability to pay. It is the individual stories and experiences of patients like Betty that really drive us to investigate, research and fight respiratory disease.

We launched more new respiratory medicines for patients in 2014, than in the previous 15 years combined.

We reinvest 20% of profits made in Least Developed Countries back into strengthening those countries’ healthcare systems.

We are looking for ways to increase access to our respiratory medicines in developing countries, for example by reducing pack sizes to enable smaller amounts to be purchased and creating low-cost formulations.

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Date of Preparation: August 2015 Job Number: RF/RESP/0208/14

For further information on our work in respiratory disease please visit www.gsk.com

Further information on our clinical trials can be found on www.gsk-clinicalstudyregister.comAdverse events should be reported by the healthcare professional in their country of origin according to local guidelines. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard.

Adverse events can also be reported to GlaxoSmithKline on: +44 (0) 800 221 441 (UK only).