ANTONY, France, September 10 /PRNewswire-FirstCall/ -- Stallergenes S.A. officially inaugurates its new pharmaceutical production unit, located in the Paris area.
Designed to comply with the most stringent EMEA (European Medicines Agency) and FDA (US Food and Drug Administration) standards, this unit will produce desensitisation treatments for all markets, primarily in Europe and North America.
This investment worth more than 20 million euros will incorporate the production of the active substance for the Oralair(R) Grasses tablet and increase the production capacity for Staloral(R), to meet the needs of an expanding international marketplace.
"For Stallergenes, this investment marks a major step forward. This new production unit will help the company break into the tough U.S market and increase its production capacity tenfold," states Albert Saporta, Chairman and CEO of Stallergenes.
ABOUT ORALAIR(R) GRASSES
Oralair(R) Grasses is a fast-dissolving sublingual desensitisation tablet indicated in allergic rhino-conjunctivitis caused by grass pollen for patients with moderate to severe symptoms unsatisfied with or inadequately controlled by symptomatic treatments. Oralair(R) Grasses contains a mix of five standardised grass allergens, mimicking patients' natural exposure: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum). In June 2008, Oralair(R) Grasses was granted a marketing authorisation in adults in Germany and a paediatric extension of its indications is expected by the end of the year. Stallergenes then plans to launch a mutual recognition procedure in the near future, with a view to marketing Oralair(R) Grasses in other European countries in both indications.
Staloral(R) is an NPP (named patient product) sublingual solution
(drops to be placed under the tongue)
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