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[DewDiligence]

NVA237 Succeeds in ‘GLOW1’ Phase-3 Study in COPD

[NVA237 is a long-acting muscarinic antagonist (LAMA) that NVS is developing as a monotherapy for COPD and as a combination therapy with QAB149 for asthma and COPD. Please see #msg-60523825 and #msg-60733567 for background.]

http://finance.yahoo.com/news/Phase-III-Data-Show-NVA237-prnews-3721282702.html?x=0&.v=1

›Source: Sosei Group
Tuesday April 19, 2011, 2:00 am EDT

TOKYO, April 19, 2011 /PRNewswire-FirstCall/ --

- Data From the Novartis Pivotal GLOW1 Study Show Once-Daily NVA237 met its Primary Endpoint, Demonstrating Superior Bronchodilation (Trough FEV1) Relative to Placebo (p<0.001) at 12 Weeks

- NVA237 Significantly Improved Lung Function While Demonstrating a Good Safety Profile in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

- Detailed Results to be Presented at a Scientific Congress in H2 2011

Sosei Group Corporation announces that NVA237, a long-acting muscarinic antagonist (LAMA) being investigated as a once daily treatment for chronic obstructive pulmonary disease (COPD), achieved its primary endpoint in a Phase III study. As part of its first quarter earnings release today, Novartis confirmed results from the first Phase III clinical trial with once-daily NVA237 (glycopyrronium bromide) show that it significantly improved lung function while demonstrating a good safety profile in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

The pivotal double-blind 26-week GLOW1 study met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function (p<0.001).

The incidence of adverse events was similar in the NVA237 treated patients and in those receiving placebo. Detailed data will be presented at a scientific congress in H2 2011.

Mr Shinichi Tamura, CEO of Sosei, said:

"We are very encouraged that results from the initial pivotal GLOW1 trial, showing significantly increased lung function with a positive safety profile, have provided further confirmation of the clinical potential of NVA237 as a novel once-daily LAMA therapy for COPD patients."

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD. The first launch for QVA149; the combination of NVA237 with Novartis' once-daily, long-acting beta2-agonist (LABA), indacaterol, is planned for 2013. Indacaterol is now approved in more than 50 countries and available in more than 20, with US approval dependent on an FDA decision expected in July 2011.

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.‹