Vectura Group plc: Interim Management Statement
Published: Jul 22, 2011
On 23 May 2011, Vectura reported its Final Results for the year ended 31 March 2011. Revenues increased by 7% to £42.9m and loss after tax fell by 14% to £8.8m. The Group ended the year with a strong cash position of £74.4m and trading since 1 April 2011 has been in line with the Board’s expectations.
Vectura and its licensees have made good progress since the start of the financial year with the key events highlighted below:
- NVA237 (COPD)
- Data from Novartis’ pivotal Phase III GLOW1 study announced in April 2011 demonstrated that NVA237 significantly improved lung function while demonstrating a good safety profile in patients with moderate-to-severe COPD
- NVA237 met its primary endpoint, demonstrating superior bronchodilation (trough FEV1) relative to placebo (p<0.001) at 12 weeks
- Data from Novartis’ pivotal Phase III GLOW2 study announced in June 2011 demonstrated that NVA237 is superior to placebo and similar to tiotropium in improving lung function in chronic obstructive pulmonary disease (COPD)
- NVA237 provided superior 24-hour bronchodilation to placebo (p<0.001) with comparable efficacy to open-label tiotropium at 12 weeks
- Additional data from the GLOW1 study is expected at the European Respiratory Society (ERS) meeting in September 2011
- Novartis expects the first NVA237 regulatory submission by the end of 2011 and to launch the product in 2012
- QVA149 (COPD)
- In July 2011 the US Food and Drug Administration (FDA) approved Novartis’ once-daily LABA, indacaterol, at 75 mcg, for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD
- Novartis expect to commence the regulatory submissions of QVA149, the fixed-dose combination of NVA237 with indacaterol, in 2012, with the first product launches expected in 2013
- VR315 (asthma/COPD), VR632 (asthma/COPD) and VR506 (asthma)
- Continued development progress
Dr Chris Blackwell, Chief Executive of Vectura:
“We have seen some significant pipeline developments since the start of this financial year. Novartis announced further positive NVA237 Phase III data and confirmed that they will file the product by the end of 2011, with an expectation of launch in 2012. In addition, we believe that FDA approval of Novartis’ indacaterol, part of the fixed-dose combination that forms QVA149, is a positive development for the prospects of the product. Novartis expects the first product launches of QVA149 in 2013. With multiple short-term catalysts ahead from the clinical programmes, as well as potential licensing opportunities, Vectura looks forward to continued good progress in the second half of 2011.”
Vectura Group plc
+44 (0)1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Julia Wilson, Director of Investor Relations
+44 (0)20 7831 3113
Vectura Group plc develops inhaled therapies principally for the treatment of respiratory diseases. Vectura’s main products target diseases such as asthma and chronic obstructive pulmonary disease (COPD), a growing market that is currently estimated to be worth in excess of $25 billion.
Vectura has six products marketed by its partners and a portfolio of drugs in clinical and pre-clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter and GlaxoSmithKline (GSK).
Vectura seeks to develop certain programmes itself where this will optimise value. Vectura’s formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura’s business strategy.
For further information, please visit Vectura’s website at www.vectura.com