Launch of a ph.III clinical trial in adults for Oralair Grasses in the US
- Category: Vaccines
- Published on Wednesday, 29 October 2008 01:00
- Hits: 1301
Operating income expected to remain stable in 2009
France | October 27, 2008 | Stallergenes has just obtained authorization (IND) from the FDA for immediately launching a phase III clinical trial in the United States with Oralair® 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®, 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® Mites pivotal study, the Oralair® Birch pollen (rBet v 1) study, the Oralair® Grasses long term efficacy and this one about Oralair® 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.”