A new generation of methods for th allergen immuno ration of

PRESS RELEASE
Paris, 14 June 2013
A new generation of methods for the use of grass pollen, a raw material in
allergen immunotherapy treatments
Stallergenes, a pharmaceutical company specialising in the treatment of allergies by allergen
immunotherapy (ITA), has developed a new generation harvesting machine intended for the extraction
of grass pollen used in the manufacture of its medication. Both the procedure and the technique behind
processing pollen – carefully designed and tested by Stallergenes on their production site located in
Amilly (Loiret district) – have proven effective in the production of high quality raw materials.
Since the opening of the Amilly site in 2011, Stallergenes has proven its expertise in terms of pollen
production and processing, and through continued investment, it now has developed a new generation of
harvesting methods. Stallergenes’ innovation lies in the sophisticated techniques used in the harvesting
and conversion of pollen into raw material for biological medicine. The very complex process requires real
know-how, as the quality of the pollen extracts depends greatly on its purity, the processing it has
undergone and the method of extraction used.
Since 2011, the Amilly production site has been dedicated to the production and treatment of grass
pollen and has ensured optimum control of the entire production chain for the medication. Today on the
site, Stallergenes operates on nearly 100 hectares of fields to produce its pollen, with the aim of
eventually supplying 50% of its grass pollen needs.
Objective: greater harvesting capacity and better quality of raw materials
With this 8m wide machine, Stallergenes experts have
developed a unique procedure for collecting and
storing pollen. This machine specifically harvests the
pollen grains and preserves them without altering
their allergenic properties. This new generation
machine, designed and manufactured in France and
the subject of several patents, allows an increase in
immediate harvesting capacity.
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"With this new investment, we can increase our production by 30%. The majority of pollen emission takes
place during the first hour of harvest. Increasing immediate harvesting capacity was a priority to allow the
collection of a greater quantity of pollen," explains David Brispot, Head of the production unit at Amilly.
New engines that meet the latest environmental standards are another advantage of the new machine.
When pollens are extracted from fields, they follow different
processing steps before being converted into an active
ingredient. The purification process is the key stage in this, for
it ensures good quality. During these processing stages, the
pollens are crushed, then sieved, dried and finally stored. The
pollen extracts are carefully checked after each stage in line
with Good Manufacturing Practice.
Key Figures
 Nearly 100 hectares of pollen
culture from 5 types of grasses
 1 ha -> 15 kg of raw materials
-> 5 kg of processed pollen
The Amilly site: better control of raw materials to command the entire processing value chain
Working closely with the farmers of Loiret has
meant that in 3 years Stallergenes has increased
the initial surface of cultivated fields by nearly
50% in order to produce the pollen from five
grasses: Rye Grass (Lolium perenne), Meadow
Grass (Poa pratensis), Timothy Grass (Phleum
pratense), Cocksfoot and Sweet vernal grass
(Anthoxanthum odoratum). Achieving this is
subject to very strict specifications that prohibit
the use of pesticides and chemical fertilisers.
Stallergenes chose the historically agricultural region of Amilly (Loiret district) for its new production unit
because it offers favourable climatic conditions for the cultivation of all five grasses.
Innovation for patients allergic to grasses
Its sublingual immunotherapy tablet, Oralair® contains extracts of the five grass pollens, which can be
found throughout Europe.
Oralair® is marketed in 20 countries and has been available in France since the end of 2012. Recently
launched in Canada, this is the first immunotherapy tablet to be registered on the North American
continent. Stallergenes has announced an important milestone in bringing this treatment to market in the
United States – a favourable opinion has been received from the U.S. Food and Drug Administration (FDA)
in the evaluation of its registration request. This means that Stallergenes is the first pharmaceutical
company to see its application for the registration of allergen immunotherapy tablets accepted for review
by the FDA.
Oralair® has been the subject of five phase III clinical studies involving over 1,800 patients in Europe and
these results are consistent with those obtained from a phase III clinical study in adults in the United
States.
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ABOUT STALLERGENES
Stallergenes is an international biopharmaceutical company dedicated to the treatment of allergy-related
respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using
allergen immunotherapy. The leader in sublingual immunotherapy treatment, Stallergenes devotes
around 20% of its annual gross sales to Research & Development and is actively involved in the
development of a new therapeutic class: sublingual immunotherapy tablets. In 2012, the company
generated sales of € 240 million, and more than 500,000 patients were treated with Stallergenes
products.
Additional information is available at http://www.stallergenes.com
For any additional information, contact:
Hélène Rigolet
Chandler Chicco Agency
T: +33 (0)1 41 43 02 27
Caroline Pelicot-Peyronnet
Chandler Chicco Agency
T: +33 (0)1 41 43 02 26
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