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Sosei Confirms the Submission of Regulatory Applications to US FDA and Robust Phase III Results for QVA149 and NVA237

2015年01月08日 PM04:49
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TOKYO

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 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients1,2,9. 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 121,2. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies1, 2.

In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo, meeting its primary objective4,5,9. 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 studies4,5.

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 life6,7. 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 AUC0-12h) at Week 121,2.

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 AUC0-12h) after 12 weeks of treatment4,5. 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 disease7,12. 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 life7,14. 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 participation16,17.

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.

 

References

1.  

Clinicaltrials.gov. A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation. (FLIGHT 1). CQVA149A2336. http://clinicaltrials.gov/ct2/show/NCT01727141?term=CQVA149A2336&rank=1 [Accessed 17 November 2014].

2.

Clinicaltrials.gov. A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation. (FLIGHT 2). CQVA149A2337. http://clinicaltrials.gov/ct2/show/NCT01712516?term=CQVA149A2337&rank=1 [Accessed 17 November 2014].

3.

Clinicaltrials.gov. A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation. (FLIGHT 3). QVA149A2340. http://clinicaltrials.gov/ct2/show/NCT01682863?term=QVA149A2340&rank=1 [Accessed 17 November 2014].

4.

Clinicaltrials.gov. NVA237 BID Versus Placebo Twelve-week Efficacy Study. (GEM 1). NVA237A2317. http://clinicaltrials.gov/ct2/show/NCT01709864?term=NVA237A2317&rank=1 [Accessed 17 November 2014].

5.

Clinicaltrials.gov. NVA237 BID Versus Placebo Twelve-week Efficacy Study. (GEM 2). NVA237A2318. http://clinicaltrials.gov/ct2/show/NCT01715298?term=NVA237A2318&rank=1 [Accessed 17 November 2014].

6.

World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs315/en/. [Accessed 09 December 2014].

7. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.
8. Price D, West D, Brusselle G, et al. Management of COPD in the UK Primary-Care Setting: An Analysis of Real-Life Prescribing Patterns. International Journal of COPD. 2014;9:889-905.
9. Donohue JF. Minimal clinically important differences in COPD lung function. COPD. 2005 Mar;2(1):111-24.
10.

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].

11.

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+44mcg/ [Accessed 1 August 2014].

12.

Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed on 17 November 2014].

13.

World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/respiratory/copd/en/ [Accessed 12 December 2014]

14.

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].

15.

World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs310/en/. [Accessed 09 December 2014].

16.

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].

17. 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.

CONTACT

Sosei Group Corporation
Tokyo Office
Milica STOJKOVIC,
+81-(0)3-5210-3399
Investor Relations
mstojkovic@sosei.com
London
Office
Kathryn LYDON, +44-(0)20-7691-0983
PA to CEO &
Corporate Communication
klydon@sosei.com

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