Major study published in NEJM confirms Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations

1/4 Major study published in NEJM confirms Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations • FLAME study showed consistent superiority of Ultibro® Breezhaler® over Seretide® across exacerbation outcomes, lung function and health- related quality of life in COPD patients • Ultibro Breezhaler also significantly reduced the rate and prolonged the time to the first moderate or severe exacerbation, compared to Seretide • Results published in the New England Journal of Medicine are anticipated to have important implications for the care of people living with COPD Tokyo, Japan – 16 May 2016: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the announcement by Novartis yesterday of the New England Journal of Medicine publication of the head-to-head FLAME study comparing the efficacy of once- daily Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) 110/50 mcg to twice-daily Seretide® (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing chronic obstructive pulmonary disease (COPD) exacerbations. In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes 1. The published FLAME results are anticipated to impact the future management and treatment of COPD patients. Preventing exacerbations is one of the primary goals of long-term care for COPD patients. These episodes have a detrimental effect on quality of life and disease progression 2, contributing to further lung function decline 3,4 and, in severe cases, hospitalization 5 and even death2. The results of FLAME confirmed that Ultibro Breezhaler is superior to SFC in reducing exacerbation outcomes regardless of a patient’s disease severity and eosinophil levels (a type of white blood cell)1. Significantly, compared to SFC, Ultibro Breezhaler both reduced the rate of moderate or severe exacerbations with a 17% risk reduction (rate ratio, 0.83), and prolonged the time to the first of these episodes with a 22% risk reduction (hazard ratio, 0.78)1. The safety profiles of the two treatments were consistent with their known profiles. The incidence of pneumonia was higher with SFC than Ultibro Breezhaler (3.2% vs 4.8%: a statistically significant difference)1. These data were also presented to the scientific community for the first time yesterday at the 2016 Annual Meeting of American Thoracic Society (ATS) in San Francisco, USA. -Ends- Enquiries: Sosei Group Corporation Tokyo Office London Office Harumi BANSE Investor Relations Kathryn LYDON, Corporate Communications +81-(0)3-5210-3399 +44-(0)20-7691-0983 [email protected] [email protected] *a long-acting beta2-adrenergic agonist 2/4 About FLAME FLAME was a randomized, double -blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries6. Results confirmed that Ultibro Breezhaler 110/50 mcg met its primary endpoint (non - inferiority) and furthermore demonstrated superiority to SFC 50/500 mcg on the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment in COPD patients with a history of at least one exacerbation in the previous year. Against further secondary endpoints, Ultibro Breezhaler was also superior compared to SFC in reducing or improving the following1: - Rate and time to first moderate or severe COPD exacerbation - Time to first COPD exacerbation (mild/moderate/severe) - Time to first severe COPD exacerbation - Lung function (trough FEV1) - Health-related quality of life (St. George’s Respiratory Questionnaire) FLAME is part of the IGNITE Phase III clinical trial program exploring Ultibro Breezhaler for the treatment of COPD. 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 offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg 8-10 and open -label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 80 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation11. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly7,11. Ultibro® and Breezhaler® are registered trademarks of Novartis AG. About COPD Chronic obstructive pulmonary disease ( COPD) affects an estimated 210 million people worldwide12 and is the third leading cause of death13. It is progressive (usually gets worse over time), and can be a life -threatening disease14,15. 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 life14,15. Exacerbations (disease flare-ups) are a sudden worsening of COPD symptoms that can be “frightening” for patients, causing distress, anxiety and the deterioration of quality of life16. COPD exacerbations are also associated with significant healthcare resource burden and costs17, particularly due to the frequent need for hospitalization . Consequently, the prevention of exacerbations is an important goal in COPD management to improve long- term health status and conserve healthcare resources18. † a long-acting beta2-adrenergic agonist ‡ a long-acting muscarinic antagonist 3/4 About Sosei Sosei Group Corporation is an international biopharmaceutical company originating from Japan that discovers and develops innovative biopharmaceuticals for the treatment of Alzheimer's disease, schizophrenia, cancer, migraine, addiction, metabolic disease, and other indications. By utilizing its platform technologies - GPCR structure-based drug design platform technology, peptide platform technologies and nanotechnology - Sosei have established a product pipeline with first/best in class potential. Through development and commercialization partnerships Sosei have already delivered three medicines to the market (two COPD bronchodilators and an emergency contraceptive), which generate significant and stable revenue streams that enable further growth. Sosei partners include Novartis, Pfizer, Allergan, AstraZeneca, MedImmune, MorphoSys, Teva and we are actively looking for new partnerships to enhance the development of our products and help us deliver them to patients worldwide. For further information about Sosei, please visit www.sosei.com/en. References 1. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone for COPD Exacerbations. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May 2016]. 2. Soler-Cataluña JJ, Martinez-Garcia MA, Sanchez PR, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005;60:925-931. 3. Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002;57:847-52. 4. Vestbo J, Edwards LD, Scanlon PD, et al. Changes in forced expiratory volume in 1 second over time in COPD. N Engl J Med. 2011;365:1184-92. 5. Müllerova H, Maselli DJ, Locantore N, et al. Hospitalized exacerbations of COPD: risk factors and outcomes in the ECLIPSE cohort. Chest. 2015;147:999-1007. 6. Clinicaltrials.gov. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study (FLAME). NCT01782326. Available at: https://clinicaltrials.gov/ct2/show/NCT01782326?term=NCT01782326&rank=1 [Accessed 10 March 2016]. 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 10 March 2016]. 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). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf [Accessed 10 March 2016]. 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 10 March 2016]. 14. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2016. Available at: http://www.goldcopd.org/uploads/users/files/WatermarkedGlobal%20Strategy%202016(1).pdf [Accessed 10 March 2016]. 15. 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 10 March 2016]. 16. Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic obstructive pulmonary disease— a patients’ perspective. Prim Care Respir J. 2006;15:2:102-109. 17. Toy EL, Gallagher K, Stanley E, et al. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010;7:214-28. 18. Anzueto A. Impact of exacerbations on COPD. European Respiratory Review. 2010;19:116:113-118. # # # 4/4 Sosei Group Corporate 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 parties; 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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