A new development and marketing alliance between Swiss drugmaker Novartis and Schering-Plough of the USA is aiming to deliver a once-daily, fixed-dose treatment for asthma and chronic obstructive pulmonary disease (COPD).
The inhaled product would combine Schering-Plough’s inhaled steroid Asmanex (mometasone furoate) with a novel beta agonist, indacaterol (QAB149), developed by Novartis.
This is not the first time that the two companies have agreed to work on a combination drug for asthma and COPD. Back in 2003, they formed an alliance to develop a treatment based on Asmanex with Novartis’ established beta agonist formoterol, and this recently entered Phase III development.
Combination products containing inhaled corticosteroids and long-acting beta-agonists are the fastest-growing segment of the worldwide asthma market, but there are still only two major players – GlaxoSmithKline with its Advair/Seretide (salmeterol and fluticasone propionate – the fourth-largest drug in the world in 2005) and AstraZeneca with Symbicort (formoterol and budesonide).
Novartis and Schering-Plough maintain that the new combination will have a great profile, mainly because it will require only one dose a day. Current combination products require dosing more than once a day because the half lives of the beta agonists they include are relatively short. Formoterol and salmeterol both have to be taken twice daily to be effective.
Asmanex is the only inhaled asthma controller therapy approved in the USA for once-daily initiation and management of asthma in patients previously treated with bronchodilators alone or inhaled corticosteroids. Meanwhile, indacaterol delivers full 24-hour bronchodilation from a single dose.
Apart Novartis and Schering-Plough’s Asmanex/formoterol combination, another near-term entrant could be SkyePharma's Flutiform (formoterol and fluticasone), which is in Phase III testing and could reach the market in 2009. SkyePharma recently signed a US licensing deal with Kos Pharmaceuticals for this product.
The worldwide respiratory market for therapies to treat asthma and COPD was estimated at approximately $15 billion in 2005 and is expected to grow to $22 billion by 2015, according to Schering-Plough, citing figures supplied by IMS.