Message from the Chairman

2009 indisputably proved to be a turning point for Stallergenes and allergen immunotherapy

• The European registration of our grass pollen immunotherapy tablet Oralair^®, achieved in November, demonstrated our ability to meet today’s pharmaceutical regulatory requirements. 
• The clinical trial (phase IIb/III) on the Actair^® dust mite immunotherapy tablet provided unambiguous evidence of its efficiency and safety against dust mite allergic rhinitis, the most prevailing allergic disease in the world.
• The positive results of the clinical trial (phase IIb/III) on the birch pollen immunotherapy tablet (Bet v 1 recombinant) will enable us to launch the phase III trial at the end of 2010, which will lead to the European registration of the first recombinant allergen.

• The Oralair^® phase III clinical trial carried out in the US fully confirmed the results obtained in Europe.

Lastly, the results of the 3-year long-term trial on Oralair^® have demonstrated a continuing improvement in treatment efficiency.  The trial is continuing into 2010 in order to show that this effect persists after the end of the treatment.

The convergence of clinical evidence and the recognition of a European registration have established tablets as the future of allergen immunotherapy, as testified by the World Allergy Organization’s “position paper” of December 2009.  The guidelines of the European Agency, EMA, obviously substantially inspired by the development of immunotherapy tablets, were published for the first time in July 2009.  They definitely conferred the status of new therapeutic class to allergens

The company’s sales and financial results exceeded expectations in spite of unfavourable macro-economic conditions.  For the ninth year running, Stallergenes enjoyed double-digit sales (up 13%) and net profit growth (up 19%), in spite of a further significant increase in Research and Development expenditure (up 20%).  For the first time in 6 years and at the end of an unprecedented capital expenditure cycle in the Company’s history, Stallergenes posted a positive net cash position, thus further enhancing its expansion capacities.

Even though growth is expected to continue at a less buoyant pace in 2010, we expect nonetheless a further increase in our results, due to stabilised R&D expenditure.  Following the successful launch of Oralair^® in Germany in 2008, this product should be introduced to other European markets in 2010, once pricing and refund assessment procedures have been conducted.

Beyond the short-term outlook, the clinical results obtained as a whole, the European registration of Oralair^® and the Company’s sound financial position now open the way for more ambitious international expansion:

• by actively seeking a partner to make the best possible use of allergen tablets in the strategic US and Japanese markets;
• by contributing to the development of emerging markets, such as China, Korea, Russia and Latin America;
• by participating in the consolidation of the market, made inescapable by ever more stringent regulatory constraints

Based on soundly established foundations, our Company, aware of its corporate responsibilities, is turning confidently, with composure and enthusiastically to the future.

Albert Saporta
Chairman & CEO