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Altana: Allergy Drug Faces Obstacles Despite Approval

Posted on: Wednesday, 25 October 2006, 12:00 CDT

Altana's Omnaris, an intranasal corticosteroid based on ciclesonide, has been approved in the US for the treatment of seasonal and perennial allergic rhinitis in patients 12 years of age and older. However, given the major products already on the market and the recent patent expiry of Flonase, Omnaris is likely to have a limited impact on the field of allergic rhinitis treatment.

Allergic rhinitis (AR) is a chronic inflammatory disease of the nasal mucosa causing sneezing, itching, nasal congestion, and discharge. Seasonal allergic rhinitis is better known as hay fever, while perennial allergic rhinitis is a chronic condition caused by triggers such as pet dander and dust. According to the American Academy of Allergy, Asthma, and Immunology, more than 40 million Americans are currently estimated to suffer with allergic diseases.

Omnaris is an intranasal corticosteroid containing ciclesonide as active substance. Steroids are the first-line therapy for perennial AR and for moderate to severe seasonal AR. The effect of intranasal corticosteroids on nasal blockage and their anti-inflammatory properties give them an advantage over other treatments. Ciclesonide is also the active compound in Alvesco, an inhaled product approved in Europe for the treatment of persistent asthma.

Until recently, three intranasal steroid brands had a firm hold on the market: GSK's Flonase/Flixonase, Schering-Plough's Nasonex and AstraZeneca's Rhinocort. With the exception of GSK's Flonase (fluticasone), these products are protected from generic entry in the US market until at least 2014 by patents covering formulations and delivery mechanisms. Earlier this year, GSK failed in its challenge to the FDA's decision to approve Roxane Laboratories' generic fluticasone. Since Roxane's launch in March 2006, sales of Flonase have fallen 53%, with the other brands also suffering from this generic competition.

Altana - which is in the process of being acquired by Denmark's Nycomed is likely to have difficulties in positioning Omnaris successfully in the US allergic rhinitis market. The recent price erosion caused by the Flonase generics will make it hard for the new drug to gain market share.

AR is also a disease treated mostly by primary care physicians, requiring a large sales force and possibly direct-to-consumer advertising. Altana's limited resources to overcome these obstacles cast a shadow over Omnaris' commercial potential. Without the help of a major pharmaceutical company it is unlikely that Altana will be able to achieve a meaningful market share.

Source: Datamonitor

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