Altana AG has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Omnaris (Ciclesonide nasal spray), 200?g once daily.
Omnaris is an intranasal corticosteroid containing Ciclesonide as active substance. It is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older. In addition, the FDA determined Omnaris approvable for the indication in children ages 2 to 11 years of age.
"With the approval of Omnaris we offer patients with allergic rhinitis an innovative treatment option," said Dr Hans-Joachim Lohrisch, Member of the Board of Altana AG and CEO of Altana Pharma. "Omnaris will extend our Ciclesonide product platform by an important new therapeutic from Altana Pharma's own research."
Omnaris is Altana Pharma's first product, which is subject to the new out-licensing strategy regarding commercialisation in the US. The market introduction of Omnaris in the US is being planned for 2007 depending on negotiations with external partners.
Intranasal corticosteroids are considered to be the gold standard for the treatment of allergic rhinitis, and they work by reducing inflammation - the major underlying cause of nasal symptoms.
Ciclesonide, Altana Pharma is developing a broader product platform. Besides the nasal spray, Ciclesonide is also the active substance of an inhaled corticosteroid that is already approved in 39 countries worldwide for the treatment of persistent asthma. A new drug application for this inhaled corticosteroid has also been filed with the US FDA. A new drug submission (NDS) for Ciclesonide nasal spray was submitted to the Canadian regulatory authority Health Canada in January 2006. In addition, the Ciclesonide platform will also include a fixed combination product with a long-acting beta-agonist, currently in phase II of clinical development. Altana Pharma partners with Sanofi-Aventis in the US and with Teijin in Japan on various Ciclesonide based products.