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Novartis' COPD drug Seebri cleared in EU and Japan

Used with Breezhaler device in Europe and inhalation capsule in Japan

Novartis has taken a leap forward in rolling out its new chronic obstructive pulmonary disease (COPD) franchise with approvals for long-acting muscarinic antagonist (LAMA) Seebri in the EU and Japan.

Seebri (glycopyrronium bromide) has been approved as a once-daily inhaled treatment for adults with COPD, and will join Novartis' long-acting beta agonist Onbrez/Arcapta (indacaterol maleate) which is already available in the US, Europe and Japan.

Seebri has been cleared for use in Novartis' Breezhaler device in Europe, while in Japan the company received the go-ahead for an inhalation capsule formulation of the drug.

The approvals are based on the year-long GLOW trial, which showed that Seebri improved lung function, reduced shortness of breath, cut COPD exacerbations, and improved quality of life versus placebo.

In addition, the GLOW 2 study which indicated Seebri was superior to placebo and similar to Boehringer Ingelheim's LAMA Spiriva (tiotropium) in improving lung function, as measured by the forced expiration (FEV) test.

The new product is expected to reach the market in both regions later this year, while a filing for the drug in the US is expected to take place in 2014.

Both Seebri and Onbrez are expected to become useful earners for Novartis with sales up to $500m per year for each product, but the big payoff for the pharma company could come if it successfully brings a combination product based on both active ingredients - QVA149 - to the market.

QVA149 is expected to be filed in the EU and Japan by the end of the year, and analysts have suggested the product could make peak sales of $3bn to $5bn a year, potentially supplanting the current COPD market leader Seretide/Advair (salmeterol plus fluticasone propionate) from GlaxoSmithKline.

Advair is an $8bn-a-year product in asthma and COPD but is coming to the end of its patent life in Europe. QVA149 will jostle for market share with Advair generics as well as GSK's already-filed COPD follow-up Relvar/Breo (vilanterol plus fluticasone furoate) and Boehringer's olodaterol/tiotropium LABA/LAMA combination, which is expected to reach the market in 2013.

Meanwhile, the first approvals of Seebri are a major boost for Vectura, which developed glycopyrronium alongside partner Sosei and licensed the drug to Novartis in 2005.

The EU and Japanese approvals of Seebri have respectively triggered $10m and $2.5m milestone payments for the company, which will also receive royalties on sales.

3rd October 2012

From: Marketing, Regulatory

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