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:12/17/2014)... (PRWEB) December 17, 2014 Gene ... that it has entered into a technology access ... (ADM) to apply DNA2.0’s proprietary protein engineering technology, ... process. , “We are extremely excited that the ... platform. This proprietary bioengineering technology has now ...
(Date:12/17/2014)... SOUTH SAN FRANCISCO, Calif. , Dec. 17, ... positive results of a Phase 2 study evaluating ... for the treatment of patients with severe, chronic ... the current standard of care, including topical steroids ... endpoint was percent change in Visual Analog Scale ...
(Date:12/15/2014)...  GlassesOff Inc. (OTCBB: GLSO) announced today the appointment ... director of the Company,s Board of Directors. ... its CEO until its acquisition by Stanley Black ... Recognized as the inventor of the first Wi-Fi-based Active ... -based RFID solutions focused on improving operational efficiency, safety ...
(Date:12/13/2014)... (PRWEB) December 12, 2014 Clarassance, a ... announced its new name: Therabron Therapeutics , Inc. ... and bronchioles (a type of structure in the lungs ... company’s mission to develop novel protein therapeutics for the ... directors decided to change the name to mark the ...
Breaking Biology Technology:ADM and DNA2.0 Enter Into Protein Engineering Technology Access and Service Agreement 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 3Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 4AeroScout Founder Joins GlassesOff's Board of Directors 2AeroScout Founder Joins GlassesOff's Board of Directors 3Maryland-based Biotech Company's Path Forward in Treating Respiratory Diseases Sparks Name Change 2
... ... used by a team of international researchers to further investigate a genetic link to podoconiosis. ... rock in tropical Africa, Central America and northwest India. , ... (PRWEB) October 1, 2009 -- DNA Genotek , a ...
... ... Food and Drug Administration (USFDA) will host Assessing Benefits and Risks of Medicinal Products in ... ... Drug Information Association (DIA) and the US Food and Drug Administration (USFDA) will host ...
... ... , ... 1, 2009 -- Artemis Health Institute has entered into a partnership with New York-based Memorial ... will focus on three core areas -- clinical care, research and training. , , , ...
Cached Biology Technology:Researchers Use Oragene●DNA to Find Genetic Link to Neglected Tropical Disease 2Researchers Use Oragene●DNA to Find Genetic Link to Neglected Tropical Disease 3Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop 2Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop 3Memorial Sloan-Kettering Selects Artemis as Affiliate for India 2Memorial Sloan-Kettering Selects Artemis as Affiliate for India 3
(Date:12/17/2014)... DUBLIN , Dec. 16, 2014 Research ... announced the addition of the "Global Chemical ... http://photos.prnewswire.com/prnh/20130307/600769 ... is the increasing demand for medical sensors in ... patient data for quick and correct diagnosis during ...
(Date:12/11/2014)... , Dec. 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/9ql3kr/biometrics_market ) has announced ... India 2015-2019" report to their offering. ... market is the adoption of multimodal biometric systems. ... of an individual for verification and identification purposes. ...
(Date:12/10/2014)... RALEIGH, N.C. , Dec. 9, 2014  Valencell, ... announced it is seeing a staggering demand from its ... demand, the Company revealed, is not solely coming from ... industries as well. "A wearable is only ... a result, accuracy is the ultimate driver in long-term ...
Breaking Biology News(10 mins):Global Chemical Sensor Market 2015-2019: Key Vendors are Abbott Laboratories, Bayer, Hoffmann La-Roche, Johnson & Johnson, NGK Spark Plugs and Robert Bosch 2Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2Wearable Technology Products Demand Highly Accurate Biometric Technology 2
... of different wet and dry foods, cats are able ... to achieve a consistent intake of protein, fat and ... Journal of Comparative Physiology B , the research ... their food selection despite differences in the macronutrient content, ...
... protein coat (capsid) of viruses assembles, published in BioMed ... shows that the construction of intermediate structures prior ... efficient than constructing the capsid protein by protein (direct ... protection and propagation of the viral genome. Many viruses ...
... a big difference to climate predictions according to new research ... Massachusetts. Difficult-to-forecast polar mesoscale storms occur frequently over ... models. Research published today in Nature Geoscience ... of climate change in years to come. Polar ...
Cached Biology News:Cats are able to navigate complex combinations of wet and dry foods to achieve a consistent intake of protein, fat and carbohydrate 2Do-it-yourself viruses: How viruses self assemble 2'Missing' polar weather systems could impact climate predictions 2
... Gene silencing experiments often call for ... NeoFX Transfection Agent refines siRNA transfection ... NeoFXs lipid-based formulation can be used ... they are subcultured without increased ...
Kit for BASE20/50 dual control unit, includes mounting plate, HOLDER50T, HEATERPAD50, SRTDX temperature probe(s)....
... CHEMICON® CaspaTag™ Pan-Caspase In Situ Assay Kit ... active caspases in cells undergoing apoptosis. The ... for use in diagnostic or therapeutic procedures. ... use a novel approach to detect active ...
... nM is available for in vivo ... in: Z. Hassani, G.-F. Lemkine, P. Erbacher, ... B.-A. Demeneix. Lipid-mediated siRNA delivery down regulates ... at picomolar levels. J. Gene Med., 2005, ...
Biology Products: