The two companies have agreed to amend their previous agreement, signed in 2004, covering an improved version of the asthma drug budesonide, delivered via a nebulisers, that makes use of Elan's NanoCyrystal technology.The new deal provides additional rights to MAP for the use of NanoCrystal technology for the treatment of multiple respiratory diseases.
The NanoCrystal technology is designed to improve the solubility and therefore the absorption of drugs by processing them into tiny nanoparticles - typically less than 1000 nanometers (nm) in diameter, which are produced by milling the drug substance using a proprietary wet milling technique. These are stabilised against agglomeration by surface adsorption of selected GRAS (Generally Regarded As Safe) stabilisers - with the result that the drug present a much greater surface area for dissolution.
The result is an aqueous dispersion of the drug substance that behaves like a solution - a NanoCrystal colloidal dispersion which can be processed into finished dosage forms for all routes of administration. The hope is that the budesonide formulation utilising this technology may result in a product that will have a superior pharmaceutical delivery and clinical profile when administered via nebuliser.
Combination therapy
Specifically, MAP and Elan's agreement now covers nebulised delivery of budesonide and combinations of budesonide with beta agonists, currently the mainstay of asthma treatment with two major products, GlaxoSmithKline's Seretide (salmeterol and fluticasone propionate) and AstraZeneca's Symbicort (budesonide and formoterol), dominating the market. The overall market for combination asthma drugs is around $5 billion a year, forecast to exceed $6 billion in 2006.
Budesonide is an anti-inflammatory corticosteroid indicated for the maintenance treatment of asthma as well as prophylactic therapy for this condition. In all delivery forms, including nebulised delivery, budesonide sales exceeded $1billion worldwide in 2004. The nebulised portion of the asthma market is the fastest growing segment, largely due to the increasingly high diagnosis rates for asthma in the paediatric population.
Timothy Nelson, CEO of MAP Pharmaceuticals said: "The growth of nebulised steroids over the past few years has demonstrated a need among physicians and patients for this type of therapy for the treatment of asthma."
Asthma is a highly prevalent chronic disease estimated to cost at least $13 billion (€10 billion) in the US alone each year. In the UK, there are four times as many people with asthma than with diabetes. The number of patients with asthma in the seven largest pharmaceutical markets is set to rise from 51.4 million in 2003 to 62.4 million in 2013, stimulating greater demand for cost-effective asthma therapies.