Vectura Announces that QVA149 Clinical Development starts in 2007 and Updates the Status of NVA237
29 Nov 2006
Vectura announces that QVA149 clinical development starts in 2007 and updates the status of NVA237
Chippenham, UK – 29 November 2006: Vectura Group plc ("Vectura"; LSE: VEC), the pulmonary product development company, today announces that at a Pharmaceutical Pipeline Update presentation yesterday in London, Novartis, highlighting the importance of its respiratory franchise, stated that initial formulation work on QVA149 had been successfully concluded and that clinical development starts in 2007.
QVA149 is a fixed dose combination product for the treatment of COPD, an irreversible and chronic obstruction of the airways. The product combines NVA237, the once daily long acting muscarinic antagonist licensed to Novartis by Vectura in 2005, together with Novartis' once daily long acting beta2 agonist, indacaterol.
Novartis also indicated at its presentation that it expected to file NDA submissions for both NVA237 and QVA149 in 2010.
Dr. Chris Blackwell, Chief Executive of Vectura, said: "Novartis' commitment to the NVA237 and QVA149 products reflects our own continued belief that these products will provide benefit for COPD patients in the future."
Enquiries
Vectura Group plc +44 (0) 1249 667 700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Financial Dynamics +44 (0) 207 831 3113
David Yates / Anna Keeble
Notes for Editors
About the NVA237 licence agreement with Novartis
Vectura and its co-development partner Sosei Group Corporation (‘Sosei") concluded a global development and commercialisation agreement with Novartis in April 2005 for their collaborative product NVA237. Novartis is responsible for developing and commercializing NVA237 both as a monotherapy and in combination with indacaterol, its once daily, long acting beta2 agonist.
Under the terms of the agreement, Vectura and Sosei have already received $15 million each and will receive up to $172.5 million each for achieving pre-agreed clinical, regulatory and commercialisation targets for both the monotherapy and combination product. These potential milestones thus total up to $375 million. In addition, royalties on product sales will be paid for the monotherapy and the combination product. If a third combination product is developed by Novartis, using NVA237, further milestones and royalties may be payable.
About Vectura
Vectura's principal focus is the development of a range of inhaled drugs for the treatment both of lung diseases and other conditions where optimised delivery via the lungs can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
Vectura's products combine its proprietary, innovative, pulmonary formulation and device technologies (Aspirair® , GyroHaler® and PowderHale®) with existing, off-patent drugs either for use in new indications or to provide inhalation as an improved route of administration. Using drugs that have already been approved in some form in at least one major pharmaceutical market lowers the risk of product development failure compared to new chemical entities. Vectura is able to secure patent protection for its portfolio by identifying new indications for off-patent compounds and applying the Company's proprietary delivery technologies to create new methods of administration. The Company has development collaborations with a number of companies, including Boehringer Ingelheim, Novartis, GSK and Chiesi and an un-named leading international pharmaceutical company.
For further information, please visit Vectura's website at www.vectura.com
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 programs; failure to obtain patent protection for discoveries; 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 statement. 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.
