Sosei, Novartis sales and marketing update

Sosei said Novartis launched once-daily Ultibro indacaterol/glycopyrronium bromide inhalation capsules delivered via the Breezhaler device in Japan to treat symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD). The product is priced at ¥271 per daily dose, or about ¥8,130 ($81.30) per month. The product is a fixed-dose combination of glycopyrronium bromide ( NVA237), an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA).

The European Commission approved the product as Ultibro Breezhaler in September as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Novartis has launched the product in Germany and the Netherlands. Novartis plans to submit a regulatory application to FDA by the end of 2014. Novartis already markets the individual components of Ultibro Breezhaler in the EU. The pharma markets glycopyrronium bromide for COPD in Europe as Seebri Breezhaler, and in Japan, Canada and Australia. Novartis also markets indacaterol for COPD in about 100 countries, including the U.S. and in those of the EU under the name Onbrez Breezhaler. ...