ANTONY, France, October 27 Stallergenes hasjust obtained authorization (IND(1)) from the FDA for immediately launching aphase III clinical trial in the United States with Oralair(R) Grasses in thetreatment of allergic rhinoconjunctivitis to grass pollens in adults.
The aim of the study, which will be conducted in 450 American patientsduring the 2009 pollen season, is to confirm the efficacy and good toleranceof the product in adults and to support the application for authorization tomarket it in the United States.
"This IND application for a phase III study is testimony to our company'scapacity to meet the FDA's requirements," states Albert Saporta, President &CEO of Stallergenes. "In order to reinforce our attractiveness as we lookforward to the prospect of a US partnership for marketing Oralair(R), we arenaturally conducting this development with Quintiles, our longstandingpartner 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 stillunderway). There is no doubt that this combined cumulative experience givesus real expertise, which is crucial when it comes to setting up studies andinterfacing with agencies, particularly the FDA."
"2009 will be an exceptional year, with the results of four major phaseIIb/III or III clinical studies: the Oralair(R) Mites pivotal study, theOralair(R) Birch pollen (rBet v 1) study, the Oralair(R) Grasses long termefficacy and this one about Oralair(R) grasses in the United States."
"All of these elements will enable us, when the time comes, to optimizethe terms of a strategic partnership. The planned R&D investment levels arecompatible with the operating income in value in 2009 remaining at its 2008level."
About Oralair(R) Grasses
Oralair(R) Grasses is a fast-dissolving sublingual desensitization tabletindicated 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 (Poapratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata)and sweet vernal grass (Anthoxanthum odoratum).
Oralair(R) Grasses has been shown to be effective in rhinoconjunctivitiscaused by allergy to grass pollens from the first season, throughout theentire pollen season and during pollen peaks:
- in poly- and mono-sensitized patients and asthmatic patients,
- on every individual symptom, and, in particular, on nasal congestionand 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 andthen 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 byproviding 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 over50 countries, it is focused on providing customer-centered solutions thatconstitute the reference standard for the industry.
For further information, please consult the Web Site of the Company atwww.quintiles.com.
Stallergenes is a European biopharmaceutical company dedicated todesensitization therapies for the prevention and treatment of allergy-relatedrespiratory diseases, e.g. rhinoconjunctivitis and allergic asthma. A pioneerand leader in sublingual desensitization treatments, Stallergenes devotes 20%of its turnover in raw data to Research and Development and is activelyinvolved in the development of a new therapeutic class: sublingualdesensitization tablets.
In 2007, Stallergenes had a turnover of 147 million euros and provideddesensitization treatments to more than 500,000 patients.
Stallergenes is listed on Euronext Paris (Compartment B) and is part ofthe sample composing the SBF 120 index.
(1) An IND (Investigational New Drug) application is a request forauthorization from the US Food and Drug Administration (FDA) to carry out theclinical trials necessary to justify the therapeutic indications that may beused to market a pharmaceutical product.ISIN code: FR0000065674 Reuters code: GEN.PA Bloomberg code: GEN.FP Additional information is available at http://www.stallergenes.com