Navigation Links
STALLERGENES is Granted a Marketing Authorization for Oralair(R) in Europe
Date:11/27/2009

PARIS, November 27 /PRNewswire-FirstCall/ -- Stallergenes has been granted European approval to market Oralair(R) in both adults and children through a Mutual Recognition Procedure. Germany, the first country where Oralair(R) has been marketed, was the reference Member state.

Oralair(R) is now registered in Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, and Spain. All the countries in which Stallergenes filed its application have approved it.

Oralair(R) is an immunotherapy tablet aimed at patients suffering from severe rhinoconjunctivitis caused by grass pollens, inadequately controlled using symptomatic treatments (antihistamines, corticosteroids).

"The European registration of Oralair(R) is a major milestone for Stallergenes. It confirms the evolution of immunotherapy towards EBM-documented, well-tolerated treatments, effective from the very first season. Immunotherapy tablets now share the same level of recognition as conventional pharmaceuticals and form a new therapeutic class: allergens. The next step is to implement the price and reimbursement assessment procedures prior to the launch country by country," says Albert Saporta, Chairman and CEO of Stallergenes.

About Oralair(R)

The Oralair(R) active substance consists of a set of pollens corresponding to the epidemiological characteristics of patient exposure in Europe: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum).

From the outset, its clinical development has taken into account the benefit to patients: proven efficacy, safety, ease of use, compliance, and cost-containment through a pre- and coseasonal protocol (the treatment is taken for four months prior to the pollen season and then throughout it, for three consecutive seasons) rather than a perennial protocol (when the treatment is taken all year round). A pharmacodynamic study has demonstrated that Oralair(R) is effective from the first month of treatment.

The clinical development program for Oralair(R) is continuing. The results of three phase III clinical studies are expected by the end the year: the US study in adults, the third year of a long-term study, and the protocol optimization study. The long-term results will be available in a year.

About The Stalair(R) Program

Stalair(R) is the pharmaceutical and clinical development program for immunotherapy tablets being implemented by Stallergenes with a view to obtaining marketing registrations for pharmaceutical products in Europe and in other strategic markets.

Oralair(R) is the first project resulting from this program. A Mutual Recognition Procedure has been completed.

A positive phase IIb/III study was completed for the dust mite immunotherapy tablet, Actair(R) in allergic rhinitis in adults during the first half of 2009. A pediatric phase III study has been launched.

The Bet v 1 tablet (birch pollen recombinant) has been the subject of a positive phase IIb/III clinical trial conducted in allergic rhinitis caused by birch pollen. A confirmatory phase III study is currently being prepared with a view to EMEA registration.

The other allergens concerned by the program are ragweed for the North American market and Japanese cedar pollen for the Japanese market. Altogether, the program covers 80% of the epidemiology for all markets.

About Stallergenes

Stallergenes is a European biopharmaceutical company dedicated to immunotherapy treatments for the prevention and treatment of allergy-related respiratory diseases, such as allergic rhinoconjunctivitis, rhinitis and asthma. As of today, Stallergenes is the seventh-ranked French pharmaceutical company. A pioneer and leader in sublingual immunotherapy treatments, Stallergenes devotes 21% of its turnover, in gross terms, to Research and Development and is actively involved in the development of a new therapeutic class: sublingual immunotherapy tablets.

In 2008, Stallergenes had a turnover of 171 million euros and more than 500,000 patients were treated with Stallergenes immunotherapy products.

    Euronext Paris (Compartment B)
    SBF 120.
    ISIN code: FR0000065674
    Reuters code: GEN.PA
    Bloomberg code: GEN.FP

    Additional information is available at http://www.stallergenes.com

SOURCE Stallergenes


'/>"/>
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. STALLERGENES : Strong Business Growth: +17% and Earnings Per Share up 30%
2. Stallergenes : 3rd Quarter Sales Up 17%: 9- Month Cumulative Sales Up 17%
3. STALLERGENES: ORALAIR Grasses: Positive Results of VO52.06 Paediatric Study
4. STALLERGENES and Protein eXpert Enter Into a Partnership for Producing Mites Recombinant Allergens
5. STALLERGENES: 2007: A Further Year of Strong Growth: Up 16%
6. STALLERGENES : Further Profit Growth Acceleration of R&D Expenditure
7. Stallergenes : Sublingual Desensitisation Tablets Oralair Grasses Approved in Germany
8. Stallergenes: Q2 2008 Sales up 18% Revision Upwards of 2008 Sales Growth
9. Stallergenes: First Half Year 2008: A 19% Increase in Operating Profit and Net Profit
10. Stallergenes Inaugurates the Biggest Pharmaceutical Allergen Production Unit in the World
11. Stallergenes: Sales at end September 2008: + 17% - 2008 Sales Guidance Revised Upwards: + 14%
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 2016 , ... Researchers at the Universita Politecnica delle Marche in Ancona combed ... pleural mesothelioma. Their findings are the subject of a new article on the Surviving ... signposts in the blood, lung fluid or tissue of mesothelioma patients that can help ...
(Date:6/23/2016)... June 23, 2016   Boston Biomedical , ... compounds designed to target cancer stemness pathways, announced ... granted Orphan Drug Designation from the U.S. Food ... gastric cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin ... to inhibit cancer stemness pathways by targeting STAT3, ...
(Date:6/23/2016)... , June 23, 2016 Houston ... with the Cy-Fair Sports Association to serve as ... the agreement, Houston Methodist Willowbrook will provide sponsorship ... and connectivity with association coaches, volunteers, athletes and ... with the Cy-Fair Sports Association and to bring ...
(Date:6/23/2016)... YORK , June, 23, 2016  The Biodesign ... to envision new ways to harness living systems and ... Modern Art (MoMA) in New York City ... than 130 participating students, showcased projects at MoMA,s Celeste ... Paola Antonelli , MoMA,s senior curator of architecture ...
Breaking Biology Technology:
(Date:3/31/2016)... 2016   LegacyXChange, ... "Company") LegacyXChange is excited to release its ... to be launched online site for trading 100% guaranteed ... will also provide potential shareholders a sense of the ... an industry that is notorious for fraud. The video ...
(Date:3/29/2016)... RATON, Florida , March 29, 2016 ... or the "Company") LegacyXChange "LEGX" and SelectaDNA/CSI Protect are ... DNA in ink used in a variety of writing ... theft. Buyers of originally created collectibles from athletes on ... through forensic analysis of the DNA. ...
(Date:3/22/2016)... India , March 22, 2016 /PRNewswire/ ... market research report "Electronic Sensors Market for Consumer ... Proximity, & Others), Application (Communication & IT, ... Geography - Global Forecast to 2022", published ... industry is expected to reach USD 26.76 ...
Breaking Biology News(10 mins):