Shares in Germany’s Altana sneaked up yesterday on the news that the firm has begun selling its asthma treatment, Alvesco (ciclesonide), in the UK – the reference member state for pan-European approval. It was also good news from home, as the company announced that it has received the national marketing licence to sell the novel inhaled corticosteroid in Germany, starting next month, with further launches to follow in Europe and worldwide.
Alvesco has already been approved in Australia, where it received its first regulatory nod last year [[01/03/04h]], followed by Mexico, Brazil, Chile and Colombia. Chief executive, Hans-Joachim Lohrisch, said that the Alvesco launch marks an important step forward for Altana, noting that of the 300 million people worldwide who suffer from asthma, 10 million are to be found in the UK – the largest market in Europe.
Altana believes it has got a potential blockbuster on its hands, and analysts predict the product could achieve peak sales of over one billion euros. However, it will face stiff competition from GlaxoSmithKline’s Flovent (fluticasone) and AstraZeneca’s Pulmicort (budesonide).
Alvesco was filed in the USA by Altana’s partner, Sanofi-Aventis, at the end of last year – though the Food and Drug Administration only gave it an approvable letter saying it required additional data [[27/10/04a]]. At the time, Altana told PharmaTimes News Online that news of a delay had been misinterpreted as, upon filing at the end of 2003, and the former Aventis had pointed out that it would take between 18 and 24 months to win final approval [[05/01/04]].