ANTONY, France, October 27 /PRNewswire-FirstCall/ -- Stallergenes has just obtained authorization (IND(1)) from the FDA for immediately launching a phase III clinical trial in the United States with Oralair(R) Grasses in the treatment of allergic rhinoconjunctivitis to grass pollens in adults.
The aim of the study, which will be conducted in 450 American patients during the 2009 pollen season, is to confirm the efficacy and good tolerance of the product in adults and to support the application for authorization to market it in the United States.
"This IND application for a phase III study is testimony to our company's capacity to meet the FDA's requirements," states Albert Saporta, President & CEO of Stallergenes. "In order to reinforce our attractiveness as we look forward to the prospect of a US partnership for marketing Oralair(R), we are naturally conducting this development with Quintiles, our longstanding partner for all the post-phase I development of the Oralair program, i.e. seven phase IIb/III or III studies (studies already conducted and those still underway). There is no doubt that this combined cumulative experience gives us real expertise, which is crucial when it comes to setting up studies and interfacing with agencies, particularly the FDA."
"2009 will be an exceptional year, with the results of four major phase IIb/III or III clinical studies: the Oralair(R) Mites pivotal study, the Oralair(R) Birch pollen (rBet v 1) study, the Oralair(R) Grasses long term efficacy and this one about Oralair(R) grasses in the United States."
"All of these elements will enable us, when the time comes, to optimize the terms of a strategic partnership. The planned R&D investment levels are compatible with the operating income in value in 2009 remaining at its 2008 level."
About Oralair(R) Grasses
Oralair(R) Grasses is a fast-dissolving sublingual desensitization tablet indicated in the treatment of allergic rhinoconjunctivitis to grass pollens.
It contains a mix of five standardized grass pollens, 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).
Oralair(R) Grasses has been shown to be effective in rhinoconjunctivitis caused by allergy to grass pollens from the first season, throughout the entire pollen season and during pollen peaks:
- in poly- and mono-sensitized patients and asthmatic patients,
- on every individual symptom, and, in particular, on nasal congestion and watery eyes.
Oralair(R) Grasses is indicated as a pre- and co-seasonal treatment: treatment should be started four months before the pollen season starts and then be maintained throughout the season. Treatment should be repeated, following the same protocol, for 3 consecutive pollen seasons.
Quintiles Transnational Corp. fuels the new generation of medical care by providing a broad range of professional services in drug development, financial partnership, and marketing for the pharmaceuticals, biotechnology, and medical care industries. With over 21,000 employees, and offices in over 50 countries, it is focused on providing customer-centered solutions that constitute the reference standard for the industry.
For further information, please consult the Web Site of the Company at http://www.quintiles.com.
Stallergenes is a European biopharmaceutical company dedicated to desensitization therapies for the prevention and treatment of allergy-related respiratory diseases, e.g. rhinoconjunctivitis and allergic asthma. A pioneer and leader in sublingual desensitization treatments, Stallergenes devotes 20% of its turnover in raw data to Research and Development and is actively involved in the development of a new therapeutic class: sublingual desensitization tablets.
In 2007, Stallergenes had a turnover of 147 million euros and provided desensitization treatments to more than 500,000 patients.
Stallergenes is listed on Euronext Paris (Compartment B) and is part of
the sample composing the SBF 120 index.
ISIN code: FR0000065674
Reuters code: GEN.PA
Bloomberg code: GEN.FP
Additional information is available at http://www.stallergenes.com (1) An IND (Investigational New Drug) application is a request for authorization from the US Food and Drug Administration (FDA) to carry out the clinical trials necessary to justify the therapeutic indications that may be used to market a pharmaceutical product.
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