rns21 Oct 2010 09:02
Update on NVA237 and QVA149
&
Achievement of a development milestone for VR632
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."