Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), today announces that NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA) being investigated as a once-daily treatment for chronic obstructive pulmonary disease (COPD), has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei.
In addition, Novartis has presented new NVA237 Phase III data at the European Respiratory Society (ERS) congress. The GLOW1 and GLOW3 studies in chronic obstructive pulmonary disease (COPD) patients show that NVA237 (glycopyrronium bromide) significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class.
The GLOW1 study met its primary endpoint by showing that NVA237 50 mcg once-daily produced a significant improvement in lung function of 108 mL in trough FEV1 (forced expiratory volume of breath in one second) after 12 weeks in patients with moderate-to-severe COPD compared to placebo (p<0.001). Moreover, NVA237 had a rapid onset of action, with a 93 mL improvement in FEV1 compared to placebo at five minutes post-dose following the first dose on the first day of treatment (p<0.001).
NVA237 also significantly prolonged the time to first moderate/severe COPD exacerbation compared to placebo, and reduced the percentage of associated hospitalizations. Significant improvement in breathlessness was seen at 26 weeks compared to placebo, accompanied by a significant improvement in health-related quality of life and reduction in the use of rescue medication.
The GLOW3 study investigated the effects of NVA237 50 mcg once-daily on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one (both p<0.001).
Both studies showed that NVA237 was well-tolerated, with a similar incidence of adverse events for patients treated with NVA237 and placebo.
Mr Shinichi Tamura, CEO of Sosei, said:"The filing of this product originating from Sosei and Vectura is an important milestone for us and is further endorsement of our capabilities. The NVA237 Phase III data at ERS illustrate the potential benefits of NVA237 for patients with COPD; a multi-billion dollar market that is still growing. Novartis has a rich portfolio of once-daily inhaled therapies to help COPD patients and has stated that it expects to file QVA149, the fixed-dose combination of NVA237 and their once-daily LABA, indacaterol, in 2012. The combination of two bronchodilators with complementary modes of action is designed to give COPD patients access to two leading classes of therapy in a single inhaler for the first time."
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