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Sosei Group Corporation (“Sosei”)(TOKYO:4565) confirms the positive first results announced today by Novartis from the Phase III head-to-head LANTERN study which showed the superiority of once-daily Ultibro^® Breezhaler^® (indacaterol/glycopyrronium) 110/50 mcg in improving lung function compared to twice-daily Seretide^® Accuhaler^®* (salmeterol/fluticasone (SFC)) 50/500 mcg in COPD patients with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler met both the primary and key secondary objectives.

The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro Breezhaler to SFC in terms of lung function (trough FEV₁) after 26 weeks of treatment in patients with moderate-to-severe COPD, with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. These results will be part of the regulatory submission of Ultibro Breezhaler in China later this year.

The LANTERN study also showed superiority of Ultibro Breezhaler compared to SFC for the key secondary objective of lung function (FEV₁ AUC_0-4h) over the first four hours post dose at week 26. The safety and tolerability profile of Ultibro Breezhaler was comparable to SFC.

COPD is a major public health concern in China, ranking first in terms of the country’s disease burden¹. Recent estimates suggest that in China over 40 million people have COPD² and the overall prevalence in people aged 40 years or older is 8%¹.

COPD symptoms can have a major, negative impact on a patient’s ability to breathe and function and they reduce their quality of life³. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens⁴. There is a need for new treatment options in COPD because many patients remain symptomatic despite medical therapy⁵.

About LANTERN and ILLUMINATE studies
LANTERN was a randomized, double-blind, parallel-group, 26-week study conducted at 56 sites across China, Argentina, Chile and Taiwan⁶. The study randomized 741 patients to assess the efficacy and safety of Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg compared to SFC 50/500 mcg in patients with moderate-to-severe COPD⁶, with or without exacerbations in the previous year.

ILLUMINATE was the first study to demonstrate that Ultibro Breezhaler achieved superior lung function in patients with moderate-to-severe COPD and no history of exacerbations in the previous year, compared with twice-daily SFC 50/500 mcg⁷ administered with the Accuhaler^®* dry powder inhaler.

About Ultibro^® Breezhaler^®
Once-daily Ultibro^® Breezhaler^® (EU)/ Ultibro^® Inhalation Capsules (Japan) is an inhaled, fixed-dose combination of the long acting muscarinic antagonist (LAMA), glycopyrronium bromide (brand name: Seebri^® Breezhaler^®) and the long acting beta₂-agonist (LABA), indacaterol maleate, and was developed by Novartis under development code QVA149. Clinical trials have shown that Ultibro Breezhaler offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg and open-label tiotropium 18 mcg (Spiriva^® Handihaler^{® **})^8-11. Ultibro Breezhaler is currently approved for use in over 30 countries, including the EU, Japan, Canada and Australia, and has been launched in 7 countries including Germany and Japan.

About Seebri Breezhaler^®
Once-daily Seebri^® Breezhaler^® (EU)/ Seebri^® Inhalation Capsules 50 mcg (Japan), (NVA237, glycopyrronium bromide), is a novel inhaled long-acting muscarinic antagonist (LAMA) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Seebri has been approved as a maintenance bronchodilator treatment for COPD in over 60 countries across Europe, Japan, Canada, Australia, South America, Middle East and Asia. In addition, Novartis is conducting Phase III trial for Seebri in asthma patients.
Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura.

Ultibro^®, Seebri^®, Onbrez^® and Breezhaler^® are registered trademarks of Novartis AG.

About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients function and quality of life^3,12. It affects an estimated 210 million people worldwide¹³ and is projected to be the third leading cause of death by 2020¹². COPD 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 participation^14,15.

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. Zhong N et al. Prevalence of Chronic Obstructive Pulmonary Disease in China. A Large, Population-based Survey. Am J Respir Crit Care Med. 2007;176:753–760 (4).
2. Zhang et al. Impact of risk factors, activities and psychological disorders on the health of patients with chronic obstructive pulmonary disease in China: a cross-sectional study. BMC Public Health. 2013;13:627.
3. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97–103.
4. World Health Organization. Chronic Obstructive Pulmonary Disease Factsheet No. 315, Available at: http://www.who.int/mediacentre/factsheets/fs315/en/. [Accessed 17 April 2014].
5. Hersh CP. Pharmacogenetics of chronic obstructive pulmonary disease: challenges and opportunities. Pharmacogenomics 2010;11(2):237–247.
6. Clinicaltrials.gov. A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149 (LANTERN). NCT01709903. http://clinicaltrials.gov/ct2/show/NCT01709903 [Accessed 17 April2014].
7. Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1):51-60.
8. EMA. 2012. 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 17 April 2014].
9. 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].
10. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].
11. 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 abstract 851388; Session 346; Date: September 10 2013 Time: 8:30-10:30].
12. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf [Accessed 17 April 2014].
13. 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 17 April 2014].
14. 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.
15. 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 April 2014].
16. Seretide^® Summary of Product Characteristics [Online] Available at: https://www.medicines.org.uk/emc/medicine/2317/SPC/Seretide+100,+250,+500+Accuhaler [Accessed 24 April 2014]

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.