Navigation Links
Stallergenes: Launch of a Phase III Clinical Trial in Adults for Oralair(R) Grasses in the United States Operating Income Expected to Remain Stable in 2009
Date:10/27/2008

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 rhinoconjunc
'/>"/>

SOURCE Stallergenes
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Stallergenes: Sales at end September 2008: + 17% - 2008 Sales Guidance Revised Upwards: + 14%
2. Stallergenes: First Half Year 2008: A 19% Increase in Operating Profit and Net Profit
3. Stallergenes: Q2 2008 Sales up 18% Revision Upwards of 2008 Sales Growth
4. STALLERGENES: 2007: A Further Year of Strong Growth: Up 16%
5. STALLERGENES: ORALAIR Grasses: Positive Results of VO52.06 Paediatric Study
6. Rosetta Genomics Leverages its MicroRNA Platform Technologies to Launch Plant Biotech Initiative
7. Lilly Announces Launch of Color Differentiation System for Humalog(R) and Humulin(R) U-100 Insulin Products in the United States
8. The MaxCyte STX Scalable Transfection System to be Launched at the SBS Symposium on Cell-Based Assays
9. HealthYes! - Premier Provider of Mobile Preventive Medical Screenings - Launches in Alamo City
10. Sensorin Raises Equity Financing to Launch Novel Industrial Sensing Venture
11. Video: OneTouch(R) Teams With Online Diabetes Community to Launch Global Diabetes Handprint Project
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... of psychiatric disorders has been extremely challenging because there ... are insufficient to cause disease. Now investigators reporting in ... Cell Stem Cell describe a strategy that ... with other risk factors or environmental exposures to affect ... a genetic variant that may predispose individuals to schizophrenia. ...
(Date:7/10/2014)... forever. Nanophysics makes sure of that. Mechanics researchers at Linkping ... Physical Review E . Knowledge that can be of ... be able to sit still forever, and walk around upside ... soon be able to buy smart new fasteners that hold ... is, sooner or later the grip is lost, no matter ...
(Date:7/10/2014)... will see the two universities and NPL collaborate to ... and industry and their complementary academic strengths., Working with ... shape the scientific priorities of the UK. The establishment ... 300 high-calibre PhD students, will provide a pipeline of ... potential of the Laboratory will be grown through the ...
(Date:1/15/2014)... , Jan. 15, 2014  Bill Jacobs Automotive, a group ... is teaming up with the Heartland Blood Center and offering ... drive. The drive takes place Saturday, Jan. 18 at the ... 2 p.m. (Photo: http://photos.prnewswire.com/prnh/20140115/MN46637 )  ...
Breaking Biology Technology:New strategy could uncover genes at the root of psychiatric illnesses 2Even geckos can lose their grip 2Universities of Surrey and Strathclyde selected as strategic partners in the future operation of the National Physical Laboratory 2Universities of Surrey and Strathclyde selected as strategic partners in the future operation of the National Physical Laboratory 3Join the Bill Jacobs Auto blood drive and receive a free oil change 2
... HOPKINTON, Mass. , May 18 Caliper Life Sciences, Inc. ... drug discovery and life sciences research, today announced that it reached an ... ® evaporation product lines to Biotage AB for $16.5 million ... , ...
... Sigma-Aldrich Corporation (Nasdaq: SIAL ) will be presenting at the Baird,s ... PM CDT ( 2:15 PM EDT ) in Chicago, IL. ... http://investor.sigmaaldrich.com/ .  Users can click the "Webcast" icon to access this file. ... About Sigma-Aldrich: ...
... , May 17 Three years of teamwork between ... Gunma University Heavy Ion Medical Center used carbon ion radiotherapy to treat ... the use of Elekta,s treatment planning software, XiO® , for delivery ... , , ...
Cached Biology Technology:Caliper Enhances Strategic Focus and Increases Growth Capital with Sale of Product Lines to Biotage 2Caliper Enhances Strategic Focus and Increases Growth Capital with Sale of Product Lines to Biotage 3Caliper Enhances Strategic Focus and Increases Growth Capital with Sale of Product Lines to Biotage 4Sigma-Aldrich Corporation to Present at the Baird's 2010 Growth Stock Conference on Thursday, May 20, 2010 2Elekta / Mitsubishi Electric Collaboration Helps Japan's Gunma University Heavy Ion Medical Center Launch Advanced Carbon Ion Therapy for Treating Cancer 2
(Date:7/10/2014)... and other major cities in New Mexico, nearly every ... wastewater rather than precious potable water supplies. Across the ... all golf courses receive treated effluent. Reusing the effluent ... golf courses and homeowners alike fertilize their lawns during ... nitrate. A New Mexico State University turfgrass expert has ...
(Date:7/10/2014)... , June 30, 2014  Aware, Inc. (NASDAQ: ... and services, previously announced on June 26, 2014 that ... dividend of $1.75 per share, or approximately $40 million ... July 10, 2014 and a payment date of July ... that it had set an ex-dividend date for this ...
(Date:7/10/2014)... 2, 2014 It is a great honor ... appointment of the world-renowned Thoracic and Cardiovascular surgeon, Mark ... Dr. Ginsburg, with over 34 years of experience, ... and Good Samaritan Regional Medical Center. Dr. Ginsburg has ... 1980,s and is considered an expert in the implantation ...
Breaking Biology News(10 mins):'Tailored' water -- the latest in lawn care 2NASDAQ Sets Ex-Dividend Date for Aware, Inc.'s Special Cash Dividend of $1.75 Per Share 2Avery Biomedical Devices, Inc. announces the appointment of Mark E Ginsburg, M.D. to its Board of Directors 2
... have used a genetically reprogrammed herpes virus and an ... model metastatic disease in mice still an elusive ... study in the July 8 Gene Therapy . ... cancer survive beyond five years, despite the aggressive use ...
... in a fraction of the blink of an eye, but ... And there has been no guarantee of success, even with ... researchers have come up with a computer program to accurately ... allow scientists to peer deeper into the roots of diseases ...
... York University study has shown for the first time ... neurodevelopmental defects associated with autism, interferes with neuronal cell ... is similar in structure to naturally-occurring prostaglandins, which are ... the brain. Past clinical studies have shown an ...
Cached Biology News:Genetically reprogrammed HSV given systemically shrinks distant sarcomas 2Rice program takes on protein puzzle 2Rice program takes on protein puzzle 3York U autism-related study discovers how drug interferes with neuronal cell function 2
Kit includes your choice of reagents for labeling 3 x 10 9 cells and EasySep magnet....
Plasmid expressing PLAP reporter gene....
Puromycin resistance gene (pac), provided in a pORF plasmid. pORF is an expression plasmid selectable with Ampicillin....
...
Biology Products: