Two positive US phase III programs in COPD for QVA149 and NVA237

1 Two positive US phase III programs in COPD for QVA149 and NVA237  QVA149 improved lung function, breathlessness and health-related quality of life in moderate-to-severe COPD patients, according to EXPEDITION trial results1-7  GEM 1 & 2 studies showed NVA237 provided significant and clinically meaningful improvements in lung function in moderate-to-severe COPD patients8,9 Tokyo, Japan – 21 May 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the positive results announced today by Novartis from two pivotal Phase III clinical trial programs for QVA149 (indacat erol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The EXPEDITION (i ncluding FLIGHT 1, 2 and 3 studies) and GEM programs met their primary and secondary endpoints, and the results were presented for the first time at the ATS International Conference, 15-20 May 2015, in Denver, US1-9. Data from the EXPEDITION program demons trated that QVA149, administered twice- daily, improved lung function (FEV 1 AUC 0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, meeting its primary objective 1-2. Further findings also confirmed that Novartis’ dual bronchodilator improved breathlessness, overall quality of life and COPD rescue medication use1-4. It also showed significant improvements in FEV 1 at 5 min and 15 min compared to placebo according to new pooled data from over 2,000 patients5. In the GEM 1 and 2 studies, NVA237, administered twice-daily, demonstrated significant and clinically meaningful improvements in lung function (FEV 1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo (p<0.001); meeting its primary objective8,9. Improvements in COPD symptoms, quality of life and rescue medication use in patients with moderate-to-severe airflow limitation were also observed8,9. The safety profiles of QVA149, its monotherapy components and placebo were broadly similar across the EXPEDITION studies6,7, as was NVA237 to indacaterol and placebo in the GEM studies8,9. There is an urgent need for new COPD treatments in the US as many people remain symptomatic despite receiving medical care 10. Reflecting this, evidence from the EXPEDITION and GEM programs presented today has also been used by Novartis to support current QVA149 and NVA237 US regulatory submissions. -Ends- 2 Enquiries: Sosei Group Corporation Tokyo Office London Office Milica STOJKOVIC, Corporate Communication Kathryn LYDON, Corporate Communication +81-(0)3-5210-3399 +44-(0)20-7691-0983 [email protected] [email protected] About EXPEDITION The EXPEDITION program consisted of trials, including FLIGHT 1 and 2, which were identical 12-week, multi-center, randomized, double-blind, parallel-group, placebo-and active-controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare QVA149 27.5/12.5 mcg, administered twice-daily, to its monotherapy components in terms of lung function (FEV 1 AUC 0-12h) at week 12 1-4. Breathlessness was measured by the transition dyspnea index (TDI) total score and overall quality of life by the St George’s Respiratory Questionnaire (SGRQ) total score. FLIGHT 3 was a 52-week randomized, double-blind, parallel-group study to assess the safety and tolerability of QVA149 27.5/12.5 mc g, administered twice-daily, compared to once-daily indacaterol 75 mcg in moderate -to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study7. About GEM GEM 1 and 2 were 12-week multi-center, randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, in moderate-to-sev ere COPD patients. The primary objective was to compare NVA237 to placebo in terms of lung function (FEV 1 AUC0-12h) after 12 weeks of treatment8,9. About QVA149 QVA149 (indacaterol/glycopyrronium bromide ) 27.5/12.5 mcg, administered twice daily, as used in the EXPEDITION program, has been submitted for US registration. Outside of the US, QVA149 is marketed as Ultibro ® Breezhaler® 110/50 mcg, which is a once- daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD11. Once-daily Ultibro ® Breezhaler ® is currently approved for use in over 60 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. About NVA237 NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, as used in the GEM trials, has been submitted for US registration. Outside of the US, NVA237 is marketed as Seebri® Breezhaler® 50 mcg, which is a once-daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Once-daily Seebri ® Breezhaler ® is approved for use in over 80 countries, including countries within the EU and Lat in America, Japan, Canada, Switzerland and Australia12. 3 Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Worldwide, 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 limitation 13. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly11,13. Ultibro®, Seebri® and Breezhaler® are registered trademarks of Novartis AG. About COPD COPD affects an estimated 210 million people worldwide 14 and nearly 27 million in the United States (US)15. It is a progressive lung condition associated with chronic morbidity and mortality14. Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed16. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 2010 17, and is expected to be the third leading cause of death worldwide by 203016. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ ability to function and their quality of life 14,18. It is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation19,20. About Sosei Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets. For further information about Sosei, please visit www.sosei.com. # # # References 1. Kerwin EM, Fowler Taylor A, Ayers T et al. QVA149 improves lung function to a greater extent than monocomponents in patients with moderate-to-severe COPD: The FLIGHT 1 Study. [ATS abstract 62856; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 2. Kerwin EM, Ayers T, Fowler Taylor A et al. QVA149 provides superior improvement in lung function versus its monocomponents in patients with moderate-to-severe COPD: the FLIGHT 2 study [ATS abstract 62690; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 3. Jones P, Mahler D, Fowler Taylor A, Ayers T et al. QVA149 show superior improvements in quality of life, as measured by SGRQ, compared with placebo in patients with moderate-to-severe COPD: the FLIGHT 2 study. [ATS abstract 62846; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 4. Mahler D, Fowler Taylor A, Ayers T et al. QVA149 reduces dyspnea in patients with moderate-to-severe COPD as measured by the transition dyspnea index: the FLIGHT 2 study [ATS abstract 61730; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 5. Banerji D, Fowler Taylor A, Ayers T et al. QVA149 shows rapid onset of bronchodilation versus placebo and its mono-components in patients with moderate-to-severe COPD: pooled data from the FLIGHT studies. [ATS abstract 62677; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 6. Fowler Taylor A, Ayers T, Thach C et al. Safety of QVA149 versus its monocomponents and placebo: a pooled safety analysis from FLIGHT 1 and FLIGHT 2 studies. [ATS abstract 63617; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 7. Ferguson G, Fowler Taylor A, Ayers T et al. QVA149 is safe and well tolerated in patients with moderate-to-severe COPD: FLIGHT 3, a 52-week safety study. [ATS abstract 63609; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 8. LaForce C, Pearle J, Feldman G, et al. efficacy and safety of glycopyrronium in COPD patients with moderate-to- severe airflow limitation: The GEM 1 Study. [ATS abstract 62680; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 4 9. Kerwin EM, Siler TM, Korenblat PE et al. Glycopyrronium twice daily improves lung function and quality of life and is well tolerated in COPD patients with moderate-to-severe airflow limitation: The GEM 2 Study. [ATS abstract 63673; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm]. 10. Price D, West D, Brusselle G, et al. Management of COPD in the UK primary-care setting: an analysis of real-life Prescribing Patterns. International Journal of COPD. 2014;9:889-905. 11. EMA (2015) Ultibro Breezhaler EU Summary of Pro duct Characteristics. [Online] Revised 27 January 2015. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- Product_Information/human/002679/WC500151255.pdf [Accessed 16 March 2015]. 12. EMA (2014). Seebri Breezhaler EU Summary of Product Characteristics. [Online] Revised 28 September 2012. Available at: https://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+4 4mcg/%20 [Accessed 13 April 2015]. 13. Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010;26; 11:2527–2533. doi:10.1185/03007995.2010.518916. 14. Global Alliance Against Chronic Respiratory Diseases (GARD). 8 th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed 16 March 2015]. 15. NIH NHLIB Chartbook 2012. Available at: https://www.nhlbi.nih.gov/files/docs/research/2012_ChartBook_508.pdf [Last accessed 21 April 2015] 16. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. Available at: http://www.who.int/respiratory/copd/burden/en/. [Accessed 16 March 2015] 17. National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf [Accessed 16 March 2015]. 18. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103. 19. DaCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280. [Accessed 16 March 2015]. 20. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612. # # # 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 forwardlooking 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 competitor s. 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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