Chippenham, UK – 21 October 2010: Vectura Group plc (LSE: VEC) (“Vectura”) acknowledges an announcement by Novartis as part of its quarterly earnings update today that Novartis expects the chronic obstructive pulmonary disease (COPD) products, NVA237 and QVA149, to launch in 2012 and 2013 respectively.
Vectura also announces today that it has achieved a milestone in relation to progress made with the inhaled generic combination asthma and COPD product, VR632, from Sandoz AG, the generics division of Novartis.
Update on NVA237 / QVA149 Novartis have today provided an update on NVA237 and QVA149 as part of their Q3, 2010 results presentation. Key points of note from the presentation include:
· NVA237 and QVA149 have expected launch dates of 2012 and 2013 respectively
· An announcement of NVA237 Phase III data in COPD is anticipated in Q2, 2011
NVA237 was licensed to Novartis by Vectura and its co-development partner Sosei in a 2005 deal in which the two companies could receive up to US$375 million in milestones as well as royalties on product sales. QVA149 is a once-daily, dry powder bronchodilator for inhalation combining a fixed dose of the once-daily beta2–agonist QAB149 (indacaterol) and the long-acting muscarinic antagonist NVA237 (glycopyrronium bromide) for the treatment of COPD.
Phase III trials for NVA237 and QVA149 commenced in June 2009 and May 2010 respectively. Novartis received European regulatory approval for indacaterol (Onbrez® Breezhaler® - indacaterol maleate) in November 2009 with the initial launch of the product in Germany in December 2009. US approval is subject to the FDA’s review of additional clinical data that Novartis filed at the end of September 2010.
VR632 milestone achievement VR632 is being developed as a generic combination product using Vectura’s GyroHaler ® dry powder inhaler (DPI) delivery device. It is the second inhaled combination therapy for asthma/COPD being jointly developed with Sandoz in Europe in addition to VR315. As well as today’s VR632 milestone of 0.6m, Vectura expects to receive the final VR632 development milestone in 2011 with approval milestones following thereafter. Vectura has achieved all the development milestones due for VR315 and is currently awaiting approval milestones for that product.
Dr Chris Blackwell, Chief Executive of Vectura:
“Vectura’s franchise in the respiratory sector now has four products with a clear path through to market. Novartis’ publication of its expected launch dates for NVA237 and QVA149 confirms that these two major value drivers are progressing to plan. This, together with progress being made on both VR315 and VR632, demonstrates the near- term value of these products to Vectura’s shareholders.”
Vectura’s interim results announcement date Vectura also confirms that it will be announcing its results for the six months ended 30 September 2010 on Tuesday 16 November 2010. A webcast of the event will be available on the Company’s website at www.vectura.com
Enquiries Vectura Group plc +44 (0)1249 667700 Chris Blackwell, Chief Executive Anne Hyland, Chief Financial Officer Julia Wilson, Director of Investor Relations
Financial Dynamics +44 (0)20 7831 3113 Ben Atwell Susan Quigley
About Vectura
Vectura Group plc is a company that 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 also develops products for other lung pathologies and non-respiratory diseases.
Vectura has eight products marketed by its partners and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. 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.
Vectura has development collaborations and license agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline (GSK) and Otsuka. For further information, please visit Vectura’s website at www.vectura.com
About VR315 VR315 is an inhaled combination therapy for asthma and COPD in development with Sandoz (the generic division of Novartis) in Europe using Vectura’s GyroHaler ® DPI device. Vectura licensed the European rights for VR315 to Sandoz in March 2006, in a deal worth up to 22.5m in milestones and development funding together with royalties on all products sold. The product is in late-stage development for the European market. Vectura currently retains the rights to the product for the US and other territories.
About VR632 VR632 is the second inhaled combination therapy for asthma and COPD being jointly developed with Sandoz in Europe, also using the GyroHaler ® technology. Vectura licensed the European rights for VR632 to Sandoz in December 2007 in a deal worth up to 15.5m in milestones and development funding, together with royalties on all products sold. Vectura will also earn a margin on the commercial manufacture and supply of GyroHaler ® devices and retains rights for the US and other territories.
About GyroHaler ® - “Passive” DPI device GyroHaler ® is a novel, cost-effective, multi-unit dose DPI device designed to deliver locally acting drugs to the lung. It is compact and easy to use with a small number of moulded parts, facilitating short device development times and competitive manufacturing costs. The device contains up to 60 doses and is disposable after use. It is designed to have competitive aerosolisation characteristics and to provide excellent drug protection from moisture and light using sealed foil blisters. GyroHaler ® has the potential to deliver respiratory products in an efficient and patient-friendly manner.
About the NVA237 Licence Agreement with Novartis Vectura and Sosei Group Corporation concluded a global development and commercialisation agreement with Novartis in April 2005 for their collaborative product NVA237. Novartis is responsible for developing and commercialising NVA237 both as a monotherapy and in combination with QAB149 (indacaterol), its once-daily, long-acting beta2-agonist, as QVA149.
Under the terms of the agreement, Sosei and Vectura will receive total milestones of up to $375 million for the achievement of pre-agreed clinical, regulatory and commercialisation targets for both the monotherapy and combination product. In addition, royalties on product sales will be paid for the NVA237 monotherapy and the combination product. If additional combination products are developed by Novartis using NVA237, further milestones and royalties will be payable to Sosei and Vectura.
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.
