Axentis gains ODD for cystic fibrosis related infection treatment
The ODD has been granted for the treatment of pulmonary infections caused by Pseudomonas aeruginosa, which affects about 60 per cent of people with cystic fibrosis (CF) and can result in death.
Owing to the rarity of cystic fibrosis, which affects around 30,000 people in the US, and the lack of treatments Axentis has now gained ODD status in two key markets, which confers numerous benefits to the company.
Helmut Brunar, CEO of Axentis, said: "Together with the orphan drug designation that was already achieved last year in Europe, the US designation puts Axentis Pharma in a favourable position to register Fluidosomes-tobramycin in two major world markets with substantial support of the relevant authorities and at a cost advantage for the company.
“As a result, we will be able to deliver the product at competitive prices to patients once it has passed the final clinical test phase. In addition to this, the orphan drug designation grants Axentis several years of exclusive marketing rights once the product has been launched."
The formulation
Axentis’ treatment is a liposomal formulation of tobramycin that is delivered using a standard nebulizer. By delivering tobramycin within synthetic liposomes Axentis believes it can deliver the therapeutic directly to the endobronchial sites of infection.
In preclinical and Phase I studies Axentis claims to have demonstrated superior efficacy and safety profiles than currently available treatments. Axentis is now initiating Phase II trials, with results expected in 2010.
