Seebri Inhalation Capsules 50 mcg, a new once-daily treatment for the symptoms of COPD, launched in Japan by licensing partner

1   Seebri® Inhalation Capsules 50 mcg, a new once-daily treatment for the symptoms of COPD, launched in Japan by licensing partner Tokyo, Japan – 22 November 2012 : Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that Novartis Pharma K.K. launched Seebri ® Inhalation Capsules 50 mcg (“Seebri ®”; glycopyrronium bromide), a new maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD, emphysema), in Japan today. Seebri ® is a once–daily long-acting muscarinic antagonist (LAMA) therapy based on delivery with the Breezhaler ® device. Seebri ® provides 24-hour bronchodilation and has shown to improve respir atory function in COPD patients rapidly after the first inhalation. - 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] Notes for Editors About Seebri® Inhalation Capsules 50mcg Seebri® Inhalation Capsules (glycopyrronium brom ide) is an effective and generally well- tolerated once-daily long-acting muscarinic antagonist (LAMA) maintenance therapy for the treatment of the symptoms of chronic obstructive pulmonary disease (COPD). Glycopyrronium bromide was licensed to Novartis in April 2005 by Sosei and its co- development partner Vectura. The Phase III GLOW1 and 2 trials of Seebri ® demonstrated significant improvement of respiratory function within five minutes after the first dose in the morning compared with placebo and this benefit was sustained for 24 hours daily over a 52-week period 1,2. GLOW 1, 2 and 3 trials showed that patients using Seebri ® demonstrated improved lung function, reduced shortness of breath, reduced exacerbations, reduced use of rescue medication, and improved quality of life and increased exercise endurance compared with placebo 1-3. Furthermore, the randomized, GLOW2 study which evaluated the efficacy and safety of once-daily Seebri ® compared with placebo in patients with moderate-to-severe COPD also compared as an exploratory analysis, open-label (OL) tiotropium 18 mcg to Seebri ® and placebo for all study objectives and showed that in the first four hours following administration Seebri ® provided statistically significant improvements in FEV 1, compared with OL tiotropium 18 mcg at day 1 ( P<0.001) and week 26 ( p=0.01) and numerically greater bronchodilation (FEV 1) compared with OL tiotropium 18 mcg at week 12 and week 521. In all studies, Seebri ® was shown to have an overall safety profile similar to that of placebo1-3. In a long-term study conducted in Japanese patients (GLOW4), Seebri ® was administered for 52 weeks, only 14 out of 123 patients (11.4%) experienced side effects. The main side effects included dry mouth in 2 patients (1.6%) and difficulty with urination in 2 patients (1.6%), which are common side effects of anticholinergic agents4. 2 Novartis received approval for glycopyrroni um bromide as a once-daily maintenance COPD treatment in the EU in September 2012 under the brand name Seebri ® Breezhaler®, and the product has since been launched in Germany and the UK. It has also been approved in Canada and Australia. About COPD COPD is a chronic, progressive lung dis ease that is caused by inhaling harmful substances such as tobacco smoke over a long period. Its major symptoms include cough, sputum, and exertional dyspnea, and most patients suffer from symptoms in the morning5. It is a life-threatening disease that not only significantly reduces the QOL of patients, but also gradually progresses and eventually leads to respiratory failure. According to data from epidemiological studies, the number of potential COPD patients in Japan is estimated to be 5.3 million 7, while the number of patients who have actually been diagnosed with COPD at medical institutions is approximately 173,000 6, suggesting that there are still very many patients with untreated COPD. 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. 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. Reference： 1. Kerwin E, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with moderate-to-severe COPD over 52 weeks: The GLOW2 study. Eur Resp J. 2012, 40: 1106-14. 2. D'Urzo A, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011, 12:156. 3. Beeh K, Drollmann A, Di Scala L, Smith R. Once-daily NVA237 improves exercise endurance from first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012; 7:503-513. 4. Sekiya M, et al. Safety and efficacy of NVA237 once daily in Japanese patients: the GLOW4 trial. [ERS abstract 853970; Session 245; Hall A-7; Date: Mon 3 Sep 2012, Time: 12:50-14:40.] 5. Kuyucu T, et al. A cross-sectional observational st udy to investigate daily symptom variability, effects of symptom on morning activities and therapeutic expectations of patients and physicians in COPD- SUNRISE study Tuberk Toraks. 2011: 59: 328-339 6. 厚生労働省「2008年 患者調査」 7. The Nippon COPD Epidemiology (NICE) Study – 福地ら, Respirology, 2004

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