Treatment with Ultibro Breezhaler improved cardiac function in COPD patients with lung hyperinflation

1/3 Treatment with Ultibro® Breezhaler® improved cardiac function in COPD patients with lung hyperinflation Ultibro® Breezhaler® provided significant improvements in cardiac and lung function in COPD patients with lung hyperinflation, compared to placebo CLAIM is the first study to investigate the effect of dual bronchodilation on cardiac function Data published in the Lancet Respiratory Medicine Tokyo, Japan – 22 February 2018: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) is pleased to confirm that Novartis today announced the publication of the CLAIM* study in the Lancet Respiratory Medicine, which demonstrated that treatment with once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium 110/50 mcg) significantly improved lung and cardiac function, when compared to placebo, in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation1. Many people living with COPD are at increased risk of death and disability due to co-morbid cardiovascular disease2. Lung hyperinflation is common in people with COPD3, and has been linked to impaired cardiac function and worsening of COPD symptoms, especially breathlessness4-6. CLAIM is the first study to investigate the effects of dual bronchodilation on cardiac function and lung hyperinflation1. The CLAIM study met its primary endpoint demonstrating that treatment with Ultibro® Breezhaler® led to decreased lung hyperinflation and improvements in cardiac function** after 14 days of treatment1. This translated into clinically relevant patient benefits of improved health status and breathlessness (dyspnea), studied as exploratory endpoints1. Commenting on the publication, Peter Bains, CEO at Sosei, said: “The CLAIM study provides yet another example of the strength of the Ultibro® Breezhaler® product and of the benefits it can bring to COPD patients, particularly the significant portion that also suffer from lung hyperinflation.” In the CLAIM study Ultibro® Breezhaler® was well tolerated and its safety profile was comparable with placebo1. Ultibro® and Breezhaler® are registered trademarks of Novartis AG. -Ends- About the CLAIM study The CLAIM study was a randomized, double-blinded, placebo-controlled, single-center, two period cross-over study comparing the effects of 14-day Ultibro® Breezhaler® therapy with placebo on cardiac and lung function in hyperinflated COPD patients1. It involved a total of 62 patients, of whom 57 completed both treatment periods1. All patients had moderate-to-very severe COPD and confirmed lung hyperinflation (residual volume >135% predicted).1 The primary endpoint of the study was to demonstrate the effect of 14-day once-daily Ultibro® Breezhaler® treatment on left ventricular end-diastolic volume (LV-EDV) as measured by MRI1. Secondary endpoints included effects on lung function parameters as measured by residual volume (RVol), forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)1. Cardiac assessments included right ventricular end-diastolic volume (RV-EDV), left and right ventricular stroke volume (LV-SV and RV-SV), left and right ventricular end-systolic volumes (LV- ESV and RV-ESV) and cardiac index (CI)1. About Ultibro® Breezhaler® Ultibro® Breezhaler® 110/50 mcg is a once-daily LABA†/LAMA‡ dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD7. Clinical trials have shown that it provides significant improvements in bronchodilation compared to treatments widely used as current standards of care, including salmeterol/fluticasone 50/500 mcg and open-label tiotropium (18 mcg)8–10. Ultibro® Breezhaler® is currently approved for use in over 100 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. About COPD COPD affects an estimated 210 million people worldwide12 and is the fourth leading cause of death13. It is progressive (usually gets worse over time) and can be a life-threatening disease12,14. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life12,14. Lung hyperinflation occurs in a significant proportion of patients with COPD. It occurs as a result of air trapping, due to airway obstruction. Hyperinflation causes increased breathlessness and can affect the health status of people with COPD6. About Sosei Sosei is an international biopharmaceutical company focused on the design and development of new medicines originating from its proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. The Company is advancing a broad and deep pipeline of partnered and wholly owned product candidates in multiple therapeutic areas, including CNS, cancer, metabolic diseases and other rare/specialty indications. The Company’s leading clinical programs include a proprietary Phase 2 candidate for dementia with Lewy bodies (DLB) in Japan, together with partnered candidates aimed at the symptomatic treatment of Alzheimer’s disease (with Allergan) and immuno- oncology approaches to treat cancer (with AstraZeneca). Sosei’s additional partners and collaborators include Novartis, Teva, Pfizer, Daiichi-Sankyo, PeptiDream, Kymab and MorphoSys. The Company is headquartered in Japan with R&D facilities in the UK. Sosei is listed on the Mothers Index of the Tokyo Stock Exchange (ticker: 4565). For more information, please visit http://www.sosei.com/en/. * A randomized, cross-over trial to assess the effect of lung deflation with indacaterol/glycopyrronium on ventricular filling in hyperinflated COPD patients: The CLAIM study ** As measured by left ventricular end-diastolic volume (LV-EDV) †A long-acting beta2-adrenergic agonist ‡ A long-acting muscarinic antagonist References 1. Hohlfeld JM, Vogel-Claussen J, Biller H et al. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo- controlled, single-centre trial. Lancet Respir Med 2018. Published online February 21, 2018. http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30054-7/fulltext?elsca1=tlxpr 2. Chen W, Thomas J, Sadatsafavi M. Risk of cardiovascular comorbidity in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Lancet Respir Med 2015;3:631-39 3. Mayo Clinic. Hyperinflated lungs. What does it mean? Available at: https://www.mayoclinic.org/diseases- conditions/emphysema/expert-answers/hyperinflated-lungs/faq-20058169 [Accessed December 2017]. 4. Barr RG et al. Percent Emphysema, Airflow Obstruction, and Impaired Left Ventricular Filling. New Engl J Med. 2010;362:217-227 5. Watz H et al. Decreasing Cardiac Chamber Sizes and Associated Heart Dysfunction in COPD. Chest. 2010;138:32- 38 6. Rossi, A., Aisanov, Z., Avdeev, S., Di Maria, G., Donner, C.F., Izquierdo, J.L., Roche, N., Similowski, T., Watz, H., Worth, H., et al. (2015). Mechanisms, assessment and therapeutic implications of lung hyperinflation in COPD. Respir. Med. 109, 785–802. 7. Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002679/WC500151255.pdf [Accessed December 2017]. 8. Vogelmeier C, et al . Once -daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45]. 9. Vogelmeier C, et al. Once -daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40]. 10. Banerji D, et al . Dual bronchodilation with once- daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS 2013 abstract 851388; Session 346; Date: September 10, 2013 Time: 8:30-10:30]. 11. Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26; 11:2527–2533. 12. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed December 2017]. 13. World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed December 2017]. 14. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD, 2017. Available at: http://goldcopd.org [Accessed December 2017]. # # # Contacts for Sosei Group Corporation Chris Cargill Head of Investor Relations and Corporate Communications +44 (0)7912 892 199 [email protected] Harumi Banse Corporate Communications (Japan) +81-(0)3-5210-3399 [email protected] Sosei Group Corporation Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Sosei’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third par ties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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