15th Aug 2012 07:00
Vectura Group plc
Interim Management Statement
VR315 US development milestone
Chippenham, UK - 15 August 2012: Vectura Group plc (LSE: VEC) ("Vectura or Company") today publishes an Interim Management Statement for the period from 1 April 2012 to 15 August 2012, and announces that it has achieved a milestone relating to continued US development progress on its lead asthma/COPD generic programme VR315.
VR315 (asthma/COPD) US development milestone
In August 2011, Vectura signed a licence agreement for the development, manufacturing and commercialisation of VR315 in the US with the US division of a leading international pharmaceutical company. Vectura today announces that it will be recording its first development milestone under this agreement of $3m in revenues for the period to 30 September 2012. The $3m includes the realisation of $2m of deferred revenue received in March 2012. Vectura is eligible to receive up to a further $32m upon achievement of future pre-determined development milestones. These milestones, together with the initial payment of $10m in August 2011, total $45m. In addition, Vectura will receive a royalty from all VR315 US sales.
Pipeline update
Seebri® Breezhaler® (COPD) first launch anticipated in 2012
·; On 21 June 2012, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Seebri® Breezhaler® (glycopyrronium /NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled 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.
·; The US filing for Seebri® Breezhaler® is expected in early 2014.
·; RoW submissions and reviews of Seebri® Breezhaler® are on-going.
QVA149 (an investigational drug for COPD) on track for European filing in 2012
·; Novartis reported headline Phase III data from the first four IGNITE QVA149 studies in the first half of 2012, which showed that QVA149 met all primary endpoints.
·; Phase III data to be presented at the European Respiratory Society (ERS) Annual Congress in Vienna from 1 - 5 September.
·; The US filing for QVA149 is expected at the end of 2014.
VR315 (asthma/COPD), VR632 (asthma/COPD) and VR506 (asthma)
·; Development progress on all products.
Financial update
On 26 April 2012, Vectura announced its full year results for the year ended 31 March 2012, reporting a strong cash position of £75.5m and a reduced loss after taxation of £4.4m (FY 2010/11 loss of £8.8m).
Vectura's performance from 1 April 2012 to date has been in line with the Board's expectations.
Dr Chris Blackwell, Chief Executive of Vectura commented:
"The new financial year has seen continued strong progress across our key pipeline products and the Company's financial performance has been in line with the Board's expectations. Today we announce the achievement of a US VR315 milestone, which demonstrates progress on our lead generic programme. In June, we announced the positive CHMP opinion for Seebri® Breezhaler® and in April we announced positive headline Phase III data from the investigational fixed-dose combination product, QVA149 - with more detailed results set for presentation at ERS in September.
"We anticipate a number of major catalysts in the second half of 2012, including the EU filing of QVA149 and the launch of NVA237 in Europe. As these programmes mature, we expect the resultant milestones and royalties to transform our revenue streams and financial profile, making Vectura a self-sustainable, cash-generative Company, which will provide a strong platform for the next chapter in the Company's growth."
Enquiries
Vectura Group plc | +44 (0)1249 667700 |
Chris Blackwell, Chief Executive | |
Anne Hyland, Chief Financial Officer | |
FTI Consulting | +44 (0)20 7831 3113 |
Simon Conway | |
Susan Stuart |
Notes for editors
About Vectura
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 $25bn.
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
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura'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.
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