Seebri Neohaler (glycopyrrolate) Inhalation Powder is Now Available in the United States

1/3 Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder is Now Available in the United States SEEBRI™ NEOHALER® is a long-acting muscarinic antagonist (LAMA) for people with chronic obstructive pulmonary disease (COPD) Tokyo, Japan – 20 October 2017: Sosei Group Corporation (“Sosei”); TSE Mothers Index:4565) is pleased to confirm that Sunovion Pharmaceuticals Inc. (Marlborough, Mass.,) announced that Seebri™ Neohaler® (glycopyrrolate) (“Seebri™ ”) Inhalation Powder, 15.6 mcg twice daily, is now available at pharmacies in the U.S. for the long- term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Seebri™ is a long-acting muscarinic antagonist (LAMA). The announcement builds upon Sunovion’s launch in April 2017 of Utibron™ Neohaler® (indacaterol/glycopyrrolate) (“Utibron™”), a dual-bronchodilator (LAMA/LABA) handheld inhaler for the long-term maintenance treatment of airflow obstruction in people with COPD. Sunovion entered into an exclusive license agreement with Novartis for the U.S. commercialization rights to Seebri™ , as well as Utibron™ and Arcapta® Neohaler®, on 21 December 2016. Novartis received approval from the U.S. Food and Drug Administration (FDA) for Seebri™ in October 2015. Sosei is eligible to receive royalties from Novartis on net sales of the product as well as certain milestones based on global calendar year combined net sales of Utibron™, Seebri™, Ultibro® Breezhaler® and Seebri® Breezhaler®. The royalties earned upon net sales of Seebri™ are the same as those for Seebri ® Breezhaler®. Commenting on the announcement, Peter Bains, CEO at Sosei, said: “We are pleased with today’s confirmation of the U.S. market launch of Seebri™ by Sunovion. Seebri™ is an important addition to Sunovion’s growing portfolio of specialty respiratory products, and follows on from its successful U.S. launch of Utibron™ earlier this year. We believe Sunovion will be highly effective in the commercialisation of Seebri™ and its broader portfolio given its strong established U.S. respiratory franchise and track record in COPD. “Royalties earned from sales of Seebri™ in the U.S. will make a further contribution to the substantial royalty stream we already receive from Novartis for sales of Ultibro® Breezhaler® and Seebri® Breezhaler® in Europe and the Rest of the World, and from the sales by Sunovion of Utibron™ in the U .S.” Ultibro® Breezhaler®, Seebri® Breezhaler®, UtibronTM Neohaler®, Seebri™Neohaler® are trademarks of Novartis AG. -Ends- 2/3 Notes to Editors About Long-Acting Muscarinic Antagonists (LAMAs) A long-acting muscarinic antagonist (LAMA) is a type of long-acting bronchodilator, along with long-acting beta2 agonists (LABAs). According to the GOLD report, these are currently the first-line standard of care maintenance therapy for symptomatic patients with COPD, and help the muscles around the airways in lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness and shortness of breath. LAMAs and LABAs are widely used and important therapeutic approaches for people with COPD. About COPD Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.3 Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD. It is estimated that several million more adults have undiagnosed COPD. COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S.4 COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.4 Symptoms of COPD include coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe. The symptoms of COPD can be most severe during the night and early morning. Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation. Night-time symptoms disturb sleep, reduce sleep quality and, in the long term, may be associated with development or worsening of cardiovascular diseases, cognition, depression and increased mortality. About Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder, 15.6 mcg twice daily, is a long- acting muscarinic antagonist (LAMA) approved in the U.S. for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. Seebri™ Neohaler® is delivered by a dry powder inhaler (DPI), and its active ingredient, glycopyrrolate, has an established safety and efficacy profile. In clinical trials, Seebri™ Neohaler® improved lung function and showed reduced use of rescue medication and improvements in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ) total score, which is a composite of patient- reported symptoms, activities and impact on daily living. The most common adverse reactions (≥1% and more common than placebo) reported in two 12-week clinical trials with Seebri™ Neohaler® (and placebo) were: upper respiratory tract infection, 3.4% (2.3%); nasopharyngitis, 2.1% (1.9%); urinary tract infection, 1.4% (1.3%); sinusitis, 1.4% (0.7%); oropharyngeal pain, 1.8% (1.2%). Glycopyrronium and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura. 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 GPCR structure-based drug design platform technology, Sosei has established a product pipeline with first/best in class potential. Through development and commercialization partnerships, Sosei has already delivered two 3/3 bronchodilators for COPD which generate significant and stable revenue streams that enable further growth. Sosei partners include Novartis, Allergan, AstraZeneca, MedImmune, MorphoSys, Teva, and Pfizer 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 http://www.sosei.com/en/. Contacts for Sosei Group Corporation Chris Cargill, Head of Investor Relations and Corporate Communications +44 (0)7912 892 199 [email protected] Harumi Banse, Investor Relations and Corporate Communications (Japan) +81-(0)3-5210-3399 [email protected] References 1 L Force, C, Feldman G, Spangenthal, et. al. Efficacy and safety of twice-daily glycopyrrolate in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation: the GEM1 study. International Journal of COPD. 2016:11: 1233-1243. 2 Kerwin E, Siler TM, Korenblat P, et al. Efficacy and safety of twice-daily glycopyrrolate versus placebo in patients with COPD: the GEM2 study. Chronic Obstr Pulm Dis (Miami). 2016; 3(2): In press. doi: http://dx.doi.org/10.15326/jcopdf/3.2.2015.0157 3 GOLD Guidelines 2017. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed: March 16, 2017. 4 MMWR: Morbidity and Mortality Weekly Report. Employment and Activity Limitations Among Adults with Chronic Obstructive Pulmonary Disease — United States, 2013. March 27, 2015; 64(11). Available at http://www.cdc.gov/mmwr/ 5 National Heart, Lung, and Blood Institute. “What is COPD?” Available at: http://www.nhlbi.nih.gov/health/educational/copd/what-is- copd/index.htm. Accessed: March 2, 2016 6 National Heart, Lung and Blood Institute. (2013). What Are the Signs and Symptoms of COPD? Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/copd/signs. 7 Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin. 2009;25:2043–8. 8 Roche N, Small M, Broomfield S, Higgins V, Pollard R. Real world COPD: association of morning symptoms with clinical and patient reported outcomes. COPD. 2013;10:679–86. 9 Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night -time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183–94. # # # 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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