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Sosei Group Corporation (“Sosei”) (TOKYO: 4565) confirms that the New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) was submitted to the US Food and Drug Administration (FDA) by Novartis in Q4 2014. Sosei is eligible to receive milestone payments upon the acceptance of applications by FDA.

In addition, the positive top-line results were announced today by Novartis from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support the application. The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM (including GEM 1, 2 and 3 studies) clinical trial programs met their primary and secondary endpoints.

The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV₁ AUC_0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients^1,2,9. Improvements in overall health status, a secondary endpoint based on the St George’s Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 12^1,2. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies^{1, 2}.

In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV₁ AUC_0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo, meeting its primary objective^4,5,9. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies^4,5.

Data from the EXPEDITION and GEM programs are expected to be presented at major medical congresses later this year.

COPD symptoms can have a major negative impact on a patient’s ability to breathe and perform essential daily activities, thereby reducing their quality of life^6,7. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy⁸.

About EXPEDITION

The EXPEDITION Program consisted of studies, 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 twice-daily QVA149 27.5/12.5 mcg to its monotherapy components in terms of lung function (FEV₁ AUC_0-12h) at Week 12^1,2.

FLIGHT 3 was a 52-week randomized, double blind, parallel-group study to assess the safety and tolerability of twice-daily QVA149 27.5/12.5 mcg 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 study³.

About GEM

GEM 1 and 2 were 12-week multi-center, randomized, double-blind, placebo controlled studies to assess the efficacy and safety of twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg in moderate to severe COPD patients. The primary objective was to compare twice-daily NVA237 to placebo in terms of lung function (FEV₁ AUC_0-12h) after 12 weeks of treatment^4,5. The objective of GEM 3 was to determine safety and tolerability of twice-daily NVA237 12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.

About QVA149

Twice-daily QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, as used in the EXPEDITION program, is being 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 COPD¹⁰. 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, as used in the GEM trials, is being 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 Australia¹¹.
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) estimates that 210 million people worldwide have COPD¹². Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed¹³. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 2010¹⁴ and is now also the third leading cause of death worldwide¹⁵.

COPD is progressive (usually gets worse over time), and can be a life-threatening disease^7,12. 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 life^7,14. 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 participation^16,17.

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.