13 Aug 2013
Chippenham, UK – 13 August 2013: Vectura Group plc (LSE: VEC) (“Vectura”), today publishes its Interim Management Statement for the period 1 April 2013 to 13 August 2013.
On 26 July 2013, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for approval of once-daily Ultibro® Breezhaler® (indacaterol maleate 85 mcg/glycopyrronium bromide 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation.
• QVA149 was filed with the Japanese Ministry of Health, Labour and Welfare in November 2012
• The US New Drug Application (NDA) is expected to be filed at the end of 2014
• Additional worldwide submissions and reviews are on-going
Following European and Japanese approvals on 28 September 2012 for marketing as maintenance bronchodilator therapy in adult patients with COPD, Seebri® Breezhaler® has been launched in the UK, Germany, and is currently being rolled out across other countries. Seebri® Inhalation Capsules were launched in Japan in Q4 2012.
• The US New Drug Application (NDA) is expected to be filed in early 2014
VR315 (asthma/COPD), VR632 (asthma/COPD) and VR506 (asthma)
• Development progress on all products
• The two VR506 multi-centre international clinical trials are expected to report in Q4 2013 and Q1 2014
Establishment of new respiratory business (Kinnovata) in China
• In May, we announced the establishment of Tianjin Kinnovata Pharmaceutical Company Limited (“Kinnovata”) in China…Read more