Significant recent transactions and events
The mutual recognition procedure for Oralair(R) (grass pollen desensitization tablet) started at an operational level in the second quarter and should lead to registration in most European countries by the end of 2009.
The phase IIb/III clinical study on the dust mite desensitization tablet for adult rhinitis proved positive and will support a European registration process. This study is a world first in dust mite immunotherapy, both in terms of its scale and the quality of its results.
Outlook for 2009
The 2009 sales growth guidance remains set at 10%. This level of growth should ensure operating profit remains at a level equivalent to 2008, against a background of increased R&D investments. Investments will remain at a high level, without calling into question the target of maintaining operating profitability above 15% and a positive free cash flow.
Lastly, the second half-year will be marked by a number of significant announcements. Five major phase II/III clinical study results are expected, of which three, if proving positive, will allow for registration into Oralair(R) phase III in the US, 3rd year of Oralair(R) long-term study in Europe and phase III Staloral(R) study on asthma in China.
Stallergenes is a European biopharmaceutical company dedicated to desensitization therapies for the prevention and treatment of allergy-related respiratory diseases, e.g. rhinoconjunctivitis and allergic asthma. A pioneer and leader in sublingual desensitization treatments, Stallergenes devotes 21% (gross) of its sales to Research and Development and is actively involved in the development of a new therapeutic class: sublingual desensitization tablets.
In 2008, Stallergenes had sales of EUR 171 million and provided
desensitization treatments to more than 50
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