8/13/2013 8:30:24 AM
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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 with two partners. Kinnovata will develop, manufacture and commercialise respiratory products for the rapidly growing Chinese and other regional markets in Asia.
Completion of acquisition of ProFibrix B.V. by The Medicines Company
Following the announcement on 4 June 2013 of its intention to purchase all of the outstanding share capital of ProFibrix B.V. subject to satisfactory review of the pending Phase III clinical trial results of ProFibrix's lead biologic, Fibrocaps™, The Medicines Company announced completion of the acquisition on 5 August 2013.
In accordance with the terms of a licensing agreement between Vectura and ProFibrix B.V., Vectura will receive a £2m change of control payment and it will also earn a low single digit royalty for sale of Fibrocaps™ in the major territories. As a shareholder of ProFibrix B.V., Vectura will receive a $1.5m milestone related to the successful outcome of the phase III study and Vectura will potentially receive further payments based on certain approval and sales milestones.
On 21 May 2013, Vectura announced its full year results for the year ended 31 March 2013, reporting a strong balance sheet with cash of £70.1m and an improvement in EBITDA loss to £3.4m (FY 2011/12 – loss of £4.2m).
Vectura’s financial performance from 1 April 2013 to date has been in line with the Board’s expectations.
Vectura’s interim results for the six month period to 30 September 2013 will be announced on 19 November 2013.
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. Recently, we noted that Novartis had received a positive CHMP opinion for Ultibro® Breezhaler®, which represents a very important step towards its approval in Europe. We are excited about the continued exploitation of the Group’s IP via a number of transactions and approvals including the China JV, Profibrix and the US approval of GSK’s BREO, all of which are associated with potential future royalty payments to Vectura.
“We anticipate a number of major catalysts in the second half of our financial year, including the launch of Ultibro® Breezhaler® in Europe. Worldwide submissions and reviews of QVA149 are on-going, with US filing expected at the end of 2014. We also expect the US filing of NVA237 in early 2014 and the launch of BREO™ ELLIPTA™ in the US. As these programmes mature, we expect the resultant milestones and royalties to transform our revenue streams and financial profile.
“Value growth is central to our strategy, and in order to maximise this, our intention is to shift gradually towards retaining increased economics; to this end we are evaluating suitable opportunities whilst continuing to carefully prioritise development of our existing portfolio and exercise tight control over expenses in order to manage our cash resources prudently. The Board remains confident in this strategy and in the Group’s prospects moving forward.”
Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive
Paul Oliver, Chief Financial Officer
Karl Keegan, Corporate Development Director
FTI Consulting +44 (0)20 7831 3113
John Dineen / Ben Atwell
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