German chemical and pharmaceutical group Altana has made a foray into the North American market for intranasal allergy treatments, filing for approval of a nasal spray formulation of its corticosteroid drug ciclesonide in the USA and Canada.
If approved, ciclesonide nasal spray will enter a US market for intranasal steroids valued at some $2.6 billion and in the throes of a major upheaval, with GlaxoSmithKline battling to defend its blockbuster product Flonase (fluticasone propionate) from generic competition but just facing a setback in the courts (see related article here.).
The total market for corticosteroids used to treat allergic rhinitis in the USA is even bigger, at around $6.7 billion.
A spokesman for Altana told Pharma Times News Online that the company believes ciclesonide’s local action, with minimal systemic absorption of the active agent, will make it an appealing option for patients and doctors.
There is always a degree of caution when prescribing corticosteroids because of their potential for side effects, such as cataracts, bone weakening and growth retardation in children.
The lack of systemic absorption is one reason Altana has such high hopes for ciclesonide, which is already sold as Alvesco in an inhaled formulation for asthma. Alvesco, partnered with Sanofi-Aventis in the USA, has been delayed coming to market in the USA by a Food and Drug Administration (FDA) request for more data, but is already approved in 35 countries and on the market in Europe.
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, said the spokesman.
Altana is also developing a fixed-dose combination of ciclesonide and the beta agonist formoterol, also alongside Sanofi-Aventis. This new product will tap into the shift towards dual treatment for asthma that has made blockbuster brands out of GlaxoSmithKline’s Seretide/Advair (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide and formoterol).
The agreement with Sanofi-Aventis does not include rights to the nasal spray formulation of ciclesonide.