Stallergenes inaugurates its new plant for production of grass pollen.

-The launch of these new facilities Stallergenes becomes the world’s largest producer of grass pollen and dust mites

Madrid, 2011-February Stallergenes has opened its new production unit of raw material in Amilly (Loiret, France Department). These facilities will be dedicated to the collection and processing of pollens of grass, used for the manufacture of allergen immunotherapy and, in particular, tablets of sublingual immunotherapy treatments.

Designed according to the strictest standards of pharmaceutical production, this new plant ensures the optimal control of raw premiums that they are used in the production of pollen of grasses. Stallergenes has developed a unique production process and conversion of material raw material in active pharmaceutical ingredients to achieve the highest quality and meet the high requirements of health regulatory agencies.

At the opening, Stallergenes officials explained that this collection and production process will be fully automated.

The plant currently comprises 45 hectares of fields of grass, they will be extended to 150 in the coming years, allowing cover half of the overall requirements of production of pollen from the company for five years.

In addition, the biopharmaceutical company plans to extend the functionality of this new plant for the production of dust mites, activity today in day is on the premises of Antony.

Stallergenes, which is already a world leader in the production of mites in house dust in the pharmaceutical industry, becomes, thanks to the strong investment made in this new production plant of Amilly leader in production of pollen of grasses. This investment, together with the considerable effort that we are conducting r & d, has been carried out in France in partnership with public scientific organizations involved in the study of allergy ”, stated at the inaugural Albert Saporta, President of Stallergenes.

About Stallergenes

Stallergenes S.A. is a biopharmaceutical company international, a leader in the manufacture and innovation of allergen immunotherapy treatments. Stallergenes sells its products to prevent and control the allergic disease in 50 countries by more than 10 subsidiaries in Europe and 40 agreements of distribution and collaboration around the world.

Stallergenes in Antony (Íle-de-France) factory is the major centre of production of allergens prepared specially for a patient (APEP) in the world, making it more than 150 different allergens to treat some 500,000 patients annually.

More than 20% of the annual turnover of the pharmaceutical company is aimed at research and development. 2010 Stallergenes turnover volume of 216 million euros and more than 500,000 patients were treated with products of the company.

Stallergenes Ibérica S.A. is the subsidiary of Stallergenes S.A. in our country Stallergenes Ibérica S.A. owns one portfolio of products for the treatment of 95% of patients with allergic diseases and it has been, since its implementation in Spanish territory for 11 years, by a strong work of research into new products.

on the Stalair ® program

Stalair ® is the program for pharmaceutical and clinical development of sublingual immunotherapy tablets developed by Stallergenes to obtain marketing authorization as pharmaceutical products in Europe and in the other markets strategic

Launched in 2003 in line with the directives issued in 2009 by the European Medicines Agency (EMA), the program offers the same level of recognition that standard pharmaceutical products for immunotherapy tablets.

Oralair ® is the first capsule for the program. Marketed since 2008 in Germany, was recently launched in the Netherlands, Czech Republic, Slovakia, Austria and Italy. It is in the process of being authorized and marketed in other countries.

The second project in the program are Actair ® tablets of immunotherapy against dust mites. Recently, its effectiveness has been demonstrated after four months of treatment and the permanence of its effect after only a year of treatment (study VO57.07 in Europe). Stallegernes is currently preparing documentation for registration to obtain the approval in Germany and has begun a phase III study with children. After consultations with the German governing biological products Agency (PEI), Stallergenes shall submit to the German authorities the documentation necessary for your registration authorization during the present year. Stallergenes planned marketing Actair ® in Germany at the end of 2012, and in Europe in 2013 through the mutual recognition procedure.

The compressed with rBet v 1 (recombinant of birch pollen allergen) has been tested in a study of Phase IIb/III, with positive results in to Birch pollen allergic rhinitis. Additional studies are currently being developed.

The tablets for ragweed pollen and Japanese cedar pollen are in the early stages of development.

In its entirety, the program covers 80% of the respiratory Allergy immunotherapy markets.