Sandoz receives Danish approval for AirFluSal Forspiro inhaler

Swiss drug major Novartis' (NOVN: VX) generics unit Sandoz has received Danish marketing authorization for AirFluSal Forspiro inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). Sandoz collaborated on the inhaler with UK-based inhalation product developer Vectura (LSE: VEC), which saw its shares leap 13.5% to 137.50 pence on the news.

The Danish approval follows the completion of European Union decentralized procedures (DCP) for eight EU countries, including Denmark. AirFluSal Forspiro offers the combination of salmeterol (a long-acting inhaled beta2-agonist) and fluticasone (an inhaled corticosteroid) in an inhaler. The product's safety, efficacy and equivalence have been proven in multiple clinical trials. Denmark has approved both mid and high-strength dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group.

Jeff George, global head of Sandoz, said: “The first approval of AirFluSalForspirois a key element of our strategy to introduce differentiated generic medicines. This innovative new respiratory device underscores Novartis' commitment to asthma and COPD patients and further strengthens Sandoz' global leadership in differentiated products, which comprised 43% of our sales in 2012.”