Stallergenes Launches Oralair® in France, the Only Immunotherapy Tablet with 5 Grass Pollen Tailored to the Epidemiology and Patients’ Expectations

Regulatory News:

Stallergenes S.A. (Paris:GENP) (Euronext Paris CAC small) announces the launch in France of Oralair^®, its grass pollen sublingual immunotherapy tablet, further to the publication of a Decree in the Official Journal dated 22 November 2012.

The launch, which has taken place ahead of the 2013 pollen season, means that allergy specialists can avail of this medication which is indicated to treat allergic rhinitis to grass pollen, with or without conjunctivitis.

Oralair^® is the only tablet composed of five grass pollen extracts that correspond to the epidemiological exposure of patients and is administered under discontinuous protocol. After a 3-day titration phase, Oralair^® is administered for approximately 4 months before the pollen season and until the end of the latter. The treatment resumes the following year, adhering to the same schedule. Oralair^® has been granted a social security refund rate of 15%, acknowledging the fact that it provides an improvement in actual medical benefits (ASMR IV).

"Following its launch in Australia, Canada and many European countries, we are delighted that Oralair^® is now available in France, Stallergenes’ country of origin. This is consistent with our drive for innovation and helps to strengthen our leadership in sublingual immunotherapy”, said Roberto Gradnik, Chief Executive Officer of Stallergenes.

In addition to France, Stallergenes’ grass pollen immunotherapy tablet is now available in 14 European countries¹. Oralair^® also continues to expand beyond Europe: following a positive start in Australia/New Zealand and Russia, the product has recently been launched in Canada, which makes it the first allergen immunotherapy tablet to be registered and marketed in North America.

ABOUT ORALAIR^®

With a unique galenic form and tailored to the sublingual route, Oralair® is a sublingual immunotherapy tablet consisting of five purified and calibrated pollen extracts corresponding to the epidemiological characteristics of patient exposure: rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum).

Oralair® is indicated for the treatment of grass pollen allergic rhinitis with or without conjunctivitis in adults, adolescents, children (from 5 years of age), confirmed by clinically relevant symptoms, a positive cutaneous test for grass pollen allergies and/or a positive test for the specific IgE to grass pollen. Oralair^® may be prescribed as a secondary treatment where symptomatic treatment with antihistamines or steroids has proven inadequate.

The subject of five clinical phase III studies involving over 1,800 patients in Europe, Oralair® offers an indisputable level of proof. It has also been the subject of a clinical phase III study on adults in the United States, the results of which were consistent with those achieved in Europe.

ABOUT STALLERGENES

Stallergenes is an international biopharmaceutical company specialised in the treatment by allergen immunotherapy of allergy related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma. The seventh largest pharmaceutical company in France and the leader in sublingual immunotherapy treatment, Stallergenes devotes around 20% of its gross turnover to Research & Development and is actively involved in the development of a new therapeutic class, sublingual immunotherapy tablets. In 2011, the company had sales of € 235 million and more than 500,000 patients were treated with Stallergenes products.

For further information, please visit our website: http://www.stallergenes.com

Forward-looking statements related to Stallergenes

This press release may contain forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. Such statements are based upon the current beliefs and expectations of Stallergenes’ management and are subject to risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, changes in competitive factors and reliance on suppliers. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law.

¹ Germany, Austria, Belgium, Bulgaria, Spain, Ireland, Italy, the Netherlands, Poland, Czech Republic, Romania, Slovakia, Slovenia and Switzerland