COPD Drug Seebri(R) Breezhaler(R) Receives Positive CHMP Opinion

Date: Jun-28-2012COPD patients in Phase III GLOW trials experienced improved lung reduced shortness of breath, reduced exacerbations, and improved quality of life[1,2,3,4]

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) 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(R) Breezhaler(R)
(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 treatments[5].

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 countries[1,2,3,4,6].

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

Seebri(R) Breezhaler(R) (glycopyrronium bromide/NVA237) is an investigational LAMA
developed as a once-daily inhaled maintenance therapy for the treatment of COPD.
Glycopyrronium bromide was licensed to Novartis in April 2005 by Sosei and its
co-development partner Vectura. It was submitted for regulatory approval in Europe in Q3
2011 and Japan in Q4 2011.

In addition to Seebri Breezhaler, also under development is QVA149 (indacaterol
maleate 110 mcg/glycopyrronium bromide 50 mcg), an investigational inhaled, once-daily,
fixed dose combination of glycopyrronium bromide and the LABA indacaterol maleate.

The first four Novartis QVA149 Phase III studies in the treatment of COPD all met
their primary endpoints[7,8,9,10]. 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[7,8,9,10].

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
worldwide[11] and is predicted to be the third leading cause of death by 2020[5]. 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 responsibilities[12].

Forward-looking statements
This press release contains forward-looking statements, including statements about the
discovery, development and commercialisation of products. Various risks may cause Sosei'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.

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.