TIDMVEC
RNS Number : 1912B
Vectura Group plc
22 October 2009
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Update on NVA237 and QVA149 for Chronic Obstructive Pulmonary Disease
Chippenham, UK - 22 October 2009: Vectura Group plc ("Vectura"; LSE: VEC),
announces that the Phase III trials with NVA237, which commenced in June 2009,
are proceeding to plan. Initiation of Phase III studies with QVA149 is now
expected to occur during 2010. Receipt of the associated milestone payment of
$7.5m is therefore expected during the financial year to 31 March 2011.
QVA149 is a novel once-daily, dry powder, fixed dose, bronchodilator combination
of the once-daily beta2-agonist indacaterol and the long-acting muscarinic
antagonist NVA237 (glycopyrronium bromide), in development for the treatment of
chronic obstructive pulmonary disease (COPD). Novartis announced on 25 September
2009 that indacaterol was recommended for approval in European Union to treat
patients with COPD following its regulatory submission in late 2008.
Furthermore, Novartis received a Complete Response letter from the FDA on 16th
October requesting additional information on the dosing proposed for
indacaterol.
Dr Chris Blackwell, Chief Executive of Vectura: "Progress with Phase III studies
evaluating NVA237, and the rapid review and recommendation for approval of
indacaterol in Europe, are both encouraging with regard to the development of
QVA149. We were impressed with the positive data at the European Respiratory
Society meeting, and it continues to be our belief that QVA149 has the potential
to be the first once-daily LAMA/LABA combination available to patients."
- Ends -
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 | |
+-------------------------------------------------------+-------------------+------+
Notes for Editors:
About the NVA237 Licence Agreement with Novartis
NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development
partner Sosei. Novartis intends to launch NVA237 as a once-daily, long-acting
muscarinic antagonist (LAMA) monotherapy for COPD and also in combination with
their once-daily, long-acting beta2-agonist (LABA) indacaterol (QAB149). The
combination of NVA237 and indacaterol is known as QVA149.
NVA237 entered Phase III trials in June 2009 which triggered a $7.5million
milestone payment to both Vectura and Sosei. Under the terms of the agreement,
Vectura and Sosei will each receive up to $172.5 million for achieving
pre-agreed clinical, regulatory and commercialisation targets for both the
monotherapy and combination product. These milestones total up to $375 million.
In addition, royalties on product sales will be paid for the monotherapy and the
combination product. If additional combination products are developed by
Novartis using NVA237, further milestones and royalties will be payable
About COPD
COPD is a chronic obstruction of the airways which affects 210 million people
worldwide and is projected to be the third leading cause of death by 2030.
Commonly caused by cigarette smoke and other harmful fumes COPD is a progressive
lung disease with symptoms including chronic bronchitis and/or emphysema, which
slowly progresses and eventually leads to a largely irreversible loss of lung
function. While there is no cure, bronchodilators such as LABAs and LAMAs make
breathing easier by enlarging the patient's airways, and are recognised in
international guidelines as an integral part of the treatment for COPD.
About Vectura
Vectura Group plc is a product-focused Group 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 $20 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 with several pharmaceutical companies,
including Boehringer Ingelheim, Novartis, Sandoz (the generics arm of Novartis),
Baxter, GlaxoSmithKline (GSK), Mylan, UCB and Otsuka. Vectura has been included
in the FTSE 250 index since 23 March 2009. 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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