Novartis seeks approval for new smoker's cough drug

Tue Sep 27, 2011 1:15am EDT

* Novartis expects approval for new drug in 2012

* Late stage study shows NVA237 drug improves lung function

* Drug could add $500 mln in sales to Novartis -analyst

By Aaron Gray-Block

AMSTERDAM, Sept 27 (Reuters) - Swiss drugmaker Novartis said it has applied to start selling its experimental drug to treat smoker's cough -- which afflicts 80 million people worldwide -- after tests showed that it helped patients breathe more easily.

Novartis has carried out late-stage trials for the drug, known as NVA237, because it wants to tap into the lucrative market for respiratory drugs at a time when it is facing increasing competition for its top-selling products from generic rivals.

Analysts say Novartis could earn billions of dollars if its treatments for chronic obstructive pulmonary disease (COPD), commonly known as smoker's cough, win regulatory approval. NVA237 alone could potentially add $500 million in annual sales.

On Tuesday Novartis said NVA237, used once a day, significantly increased the functioning of lungs in patients compared with a placebo and that the first dose produced a fast response. NVA237 also enabled patients to exercise longer, it added.

Dave Morris, global development head at the Respiratory unit, said Novartis applied to the European Medicines Agency for approval at the end of August and expects a final decision from authorities some time in 2012. The drug will be marketed in the European Union as Seebri Breezhaler.

In a presentation at the European Respiratory Society annual meeting in Amsterdam, Novartis said NVA237 prolonged the time before patients suffered their first moderate to severe relapse and reduced the number of hospitalisations.

In June a separate study showed NVA237, or glycopyrronium bromide, helps patients with smoker's cough -- which causes breathing trouble and chronic coughing and is sometimes fatal, in a similar way to a rival drug from Pfizer and Boehringer Ingelheim.

Novartis wants to combine NVA237 with an inhalation powder indacaterol to treat the disease as it races British drugmaker GlaxoSmithKline to be the first company to sell a two-in-one medicine. The combined treatment is being developed under the name QVA149.

Data unveiled in Amsterdam also showed a 150 mcg and 300 mcg dose of Novartis' indacaterol drug significantly improved lung function among patients after using it for six months compared with patients who were treated with a placebo.

Earlier this year, U.S. authorities approved a 75 mcg dose, but Novartis failed to win backing for its higher 150 mcg dose, a setback for Novartis in its development of QVA149.

Deutsche Bank analyst Richard Parkes estimates that NVA237 could generate annual sales of $500m by 2018, while the combined treatment could add more than $2 billion to that figure.

NVA237 was licensed to Novartis in 2005 by Vectura and its co-development partner Sosei .

Until recently, Novartis was not on the radar as a major force in lung drugs, which are more difficult to make because of the inhaler devices needed.

The field is now becoming increasingly important to Novartis as it develops new drugs and cheap generic versions of older products such as Glaxo's Advair. (Additional reporting by Katie Reid in Zurich)

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