Schering-Plough/Novartis: a Winning Combination?

Schering-Plough and Novartis have entered into a collaboration to develop and commercialize a new combination drug for asthma and chronic obstructive pulmonary disease. This is a sensible move that will bring a once-daily product to the market, giving the two companies a key competitive advantage. However, GlaxoSmithKline’s once-daily Super Advair will be a tough competitor.

The two companies’ new product will be an inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) that combines Novartis’ indacaterol (also known as QAB-149) and mometasone, the active ingredient in Schering-Plough’s Asmanex.

The fixed dose combination class is the largest drug class in the treatment of asthma and chronic obstructive pulmonary disease (COPD). GlaxoSmithKline’s Seretide/Advair (fluticasone/salmeterol) and the recently US approved Symbicort (budesonide/formoterol, AstraZeneca) are the only combination products currently on the market. Even so, sales for the class reached $5.5 billion across the seven major markets in 2005, and this is set to grow. Indeed, sales for the class are expected to rise to $12.2 billion in 2015, making it an increasingly profitable area.

Novartis has been developing QAB-149 as monotherapy for the treatment of asthma and COPD and is expected to launch this product in 2011. It will be one of the new-generation LABAs, which, thanks to their convenient once-daily dosing, have a major advantage over current LABAs. Schering-Plough’s ICS Asmanex, meanwhile, was launched in the US in 2005 and is the only inhaled asthma controller therapy approved for once-daily initiation and management of asthma patients in that market.

Building upon the successes of these two drugs individually, the once-daily dosing regime of Schering-Plough and Novartis’ indacaterol/mometasone product will be key to its future success. This should give it an important competitive edge over the majority of its rivals as many current combination products and most drugs in development are twice-daily products.

However, GlaxoSmithKline’s once-daily combination drug Super Advair, a reformulation of its Seretide/Advair product, is expected to hit the market in 2010. Not only will Super Advair compete directly with the indacaterol/mometasone product, but GlaxoSmithKline’s offering will benefit from being the first once-daily combination product to market.

Schering-Plough/Novartis’ combination product will struggle to gain market share from Super Advair, unless it can differentiate itself in terms of efficacy, safety or pricing. However, its once-daily dosing regime will continue to be a key advantage over other combination products, which should still allow for encouraging uptake and sales.