Altana of Germany has won an important new drug approval in the USA for Omnaris, a new corticosteroid nasal spray for seasonal and perennial allergic rhinitis that is tipped as a major new product for the company.
A green light has been given for Omnaris use in patients aged over 12, although the Food and Drug Administration has asked for additional information before it will approve the product for younger patients aged two to 11.
The total US market for intranasal corticosteroids used in allergic rhinitis is valued at around $2.6 billion, and has undergone a sea change this year with the start of generic competition to current market leader Flonase (fluticasone propionate) from GlaxoSmithKline, which had sales of close to $900 million in 2005.
Altana believes ciclesonide's local action, with minimal systemic absorption of the active agent, will make it an appealing option for patients and doctors as it reduces systemic exposure to corticosteroids, which have potential side effects such as cataracts, bone weakening and growth retardation in children.
Omnaris should be launched onto the US market next year, said Altana, which recently agreed to sell its pharmaceuticals business to Denmark’s Nycomed in a deal valued at 4.5 billion euros ($5.7bn).
An inhaled formulation of ciclesonide for asthma, called Alvesco, achieved sales of 8 million euros ($10m) last year, at the bottom end of Altana's expectations, but the company still insists that peak sales of a billion euros or more are possible for the franchise as a whole. Altana is also developing a fixed-dose combination of ciclesonide and the beta agonist formoterol, in partnership with Sanofi-Aventis.