Antony, France (ots/PRNewswire) - 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
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
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 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
(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.
ots Originaltext: Stallergenes
Im Internet recherchierbar: http://www.presseportal.ch
Contacts: Albert Saporta - President & CEO, Tel: +33-1-55-59-20-04;
Christian Thiry - Financial Director, Tel: +33-1-55-59-20-95, e-mail:
email@example.com; Stallergenes press relations, Lise
Lemonnier - Communication Manager, Tel: +33-1-55-59-20-96, e-mail:
firstname.lastname@example.org; Stallergenes Investor and Analyst
relations, Lucile de Fraguier - Pavie Finance, Tel:
+33-1-42-15-04-39, e-mail: email@example.com