COPD Treatment Seebri® Breezhaler® Receives Positive CHMP Opinion

Date: Jun-30-2012Vectura Group plc ("Vectura"; LSE: VEC) confirms the
information released last week by Novartis, that the European Medicines Agency's Committee
for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri®
Breezhaler® (glycopyrronium /NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per
capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms
in adult patients with chronic obstructive pulmonary disease (COPD). Seebri Breezhaler is a
long-acting muscarinic antagonist (LAMA), a type of bronchodilator that is recommended in
COPD global treatment strategies as maintenance therapy administered either alone or in
combination with other treatmentsv.

Data from three of the Novartis Phase III GLOW trials informed the CHMP's positive opinion
for Seebri Breezhaler and included 1,996 COPD patients from around the world with many in
EU countriesi,ii,iii,iv,vi.

Dr Chris Blackwell, Chief Executive of Vectura, commented:

"This positive opinion for Seebri Breezhaler is a significant value enhancing event for both
Vectura and its co-development partner, Sosei. The drug was developed to a Phase II
proof-of-concept by the two companies before being licensed to Novartis and, when
approved, will offer COPD patients an alternative once-daily inhaled treatment. This
innovative, once-daily therapy in the LAMA class has the potential to reduce breathlessness,
increase the capacity to exercise and help improve quality of life. We look forward next to
key data from Phase III studies of QVA149, the combination product of the long-acting betaagonist
Indacaterol and NVA237, with filing in Europe expected in 2012."

GLOW1 demonstrated the clinically significant superiority of Seebri versus placebo for lung
function improvements at 12 weeks measured by trough FEV1 (p





About Seebri Breezhaler

Seebri® Breezhaler® (glycopyrronium bromide/NVA237) is an investigational long-acting
muscarinic antagonist (LAMA) being developed as a once-daily inhaled maintenance
therapy for the treatment of COPD. It is expected to be one of three innovative medicines in
the Novartis COPD portfolio to be delivered using the Breezhaler® Single Dose Dry Powder
Inhaler, along with Onbrez® Breezhaler® (indacaterol) and investigational QVA149
(indacaterol 110 mcg/glycopyrronium bromide 50 mcg).
Phase III data from the GLOW 1, 2 and 3 studies demonstrated that NVA237 increased
patients' lung function over a 24-hour period compared to placebo, with a fast onset of action
at first dose, as well as improving exercise endurancei,ii,iii,vii,viii. Glycopyrronium bromide was
licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. It was
submitted for regulatory approval in Europe in Q3 2011 and Japan in Q4 2011, and
expected US filing is the beginning of 2014.

About the NVA237/QVA149 Licence Agreement with Novartis

NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner,
Sosei. Novartis expects to launch NVA237 outside the US as a once-daily monotherapy for
COPD in 2012 and as a fixed-dose combination with indacaterol, its once-daily, long-acting
beta-agonist (LABA), known as QVA149 (indacaterol maleate 110 mcg/glycopyrronium
bromide 50 mcg), in 2013. Vectura believes that QVA149 could be the first once-daily
LAMA/LABA combination to come to market for COPD. The dual activity of a muscarinic
antagonist and a beta-adrenergic agonist promises to be a potent bronchodilator and, with
convenient once-daily dosing as a fixed-dose combination, has the potential to improve
compliance and address a large and unmet need for COPD sufferers.

The first four Novartis QVA149 Phase III studies in the treatment of COPD all met their
primary endpointsvii,viii,ix,x. The results of the SHINE, BRIGHT, ENLIGHTEN and ILLUMINATE
studies, which are key components of the IGNITE program, demonstrate the potential of
QVA149 in the treatment of COPD.

Onbrez® Breezhaler® (indacaterol maleate) is a long-acting beta-agonist (LABA) that is the
only COPD treatment to offer clinically relevant 24-hour bronchodilation combined with a
rapid onset of action at first dosexi,xii,xiii,xiv. Onbrez Breezhaler has also shown significant
improvement in breathlessness scores compared to placebo and tiotropium. It was first
launched in the EU in 150 mcg and 300 mcg once-daily doses. Most recently, Novartis
launched the 75 mcg once-daily dose in the US under the brand name Arcapta™
Neohaler™. It is also available as a 150 mcg once-daily dose in Japan under the brand
name Onbrez® Inhalation Capsules.

To date, Vectura has received $35m from Novartis and, under the terms of the licence, could
receive up to an additional $152.5m for achievement of regulatory and commercialisation
targets for both the monotherapy and the combination product. In addition, royalties on
product sales will be received in the event of successful product launches. Vectura is due to
receive a milestone payment on approval by the European Medicines Agency of a marketing
authorisation in a major European country.

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or
occupational exposure, which can cause obstruction of airflow in the lungs resulting in
debilitating bouts of breathlessness. It affects an estimated 210 million people worldwidexv
and is predicted to be the third leading cause of death by 2020v. Although COPD is often
thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of
50 and 65, which means that half of the COPD population are likely to be impacted at the
peak of their earning power and family responsibilitiesxvi.

View drug information on Arcapta.
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.