U.S. FDA filing acceptance of NDAs for QVA149 and NVA237

1 U.S. FDA filing acceptance of NDAs for QVA149 and NVA237 Tokyo, Japan – 6 March 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that Novartis New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of ch ronic obstructive pulmonary disease (COPD) have been accepted for review by the US Food and Drug Administration (FDA). The filings were submitted by Novartis in Q4 2014. The acceptances trigger milestone payments to Sosei of $12.5m and $7.5m respectively. -Ends- Enquiries: Sosei Group Corporation Tokyo Office London Office Milica STOJKOVIC, Investor Relations Kathryn LYDON, PA to CEO & Corporate Communication +81-(0)3-5210-3399 +44-(0)20-7691-0983 [email protected] [email protected] About QVA149 Twice-daily QVA149 (indacaterol/glycopyrroni um bromide), 27.5/12.5 mcg, has been submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro ® Breezhaler ® 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD 1. Once-daily Ultibro ® Breezhaler ® is currently approved for use in over 50 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia. About NVA237 Twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg, has been submitted for US registration only. Outside of the US, NVA237 has been developed/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 and is approved for use in over 70 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia2. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Ultibro®, Seebri® and Breezhaler® are registered trademarks of Novartis AG. About COPD COPD is associated with chronic morbidity and mortality and The World Health Organization (WHO) estima tes that 210 million people worldwide have COPD 3. Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed 4. COPD is the third leading cause of death in 2 America, claiming the lives of 134,676 Americans in 2010 5 and is now also the third leading cause of death worldwide6. COPD is progressive (usually gets worse over time), and can be a life-threatening disease3. It makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life5. 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 participation7,8. 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. Ultibro Breezhaler EU Summary of Product Characteristics. [Online] 3 October 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002679/WC500151255.pdf [Accessed 23 July 2014]. 2. EMA (2012). Seebri Breezhaler EU Summary of product characteristics. [Online] Revised 28 September 2012 http://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+44 mcg/ [Accessed 1 August 2014]. 3. Global Alliance Against Chronic Respiratory Diseases (GARD). 8 th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed on 17 November 2014]. 4. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/respiratory/copd/en/ [Accessed 12 December 2014] 5. National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf. [Accessed 09 December 2014]. 6. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs310/en/ . [Accessed 09 December 2014]. 7. 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 17 November 2014]. 8. 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 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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