Stallergenes Greer plc Regulatory Approval
14 November 2018 - 6:00PM
UK Regulatory
TIDM0RB9
Stallergenes Greer Announces U.S. FDA Approval of Pediatric
Indication Extension for OralairĀ® Sublingual Immunotherapy Tablet
for the Treatment of Grass Pollen Allergy
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company
specializing in treatments for respiratory allergies, today
announced that it has received approval from the U.S. Food and Drug
Administration (FDA) for the extension of the indication for
OralairĀ® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and
Kentucky Blue Grass Mixed Pollens Allergen Extract), an allergy
immunotherapy sublingual tablet, to treat patients ages five to
nine with grass pollen-induced allergic rhinitis. Oralair is the
only allergy immunotherapy tablet that contains grass pollens from
five of the most common grasses in the United States and received
FDA approval in patients ages ten to 65 in 2014.
"We are very pleased to be able to make this effective and
convenient treatment option with a demonstrated safety profile
available for children ages five and over as well as adults," said
Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. "AIT can
offer a valuable benefit to patients to help treat the underlying
cause of allergies. Oralair provides an important option to
patients who seek the relief of AIT but want the convenience of
taking a tablet at home. We are committed to enabling physicians to
determine the treatment method that best meets the disease and
lifestyle needs of the patient."
Allergic rhinitis affects approximately 40 to 60 million people
in the U.S.1 and treatment options include allergy immunotherapy, a
disease-modifying treatment that treats the underlying cause of
allergy and can provide long-lasting improvements of allergy
symptoms. In the U.S. AIT can be administered sublingually as a
tablet, such as Oralair, or as an injectable formulation. Today,
fewer than 3 million allergy sufferers (i.e., 5% of the U.S.
allergic population), are treated with allergy immunotherapy.
ABOUT ORALAIR
Oralair is a sublingual tablet administration of allergy
immunotherapy that contains a mix of five grass pollens: Kentucky
Blue, Orchard, Perennial Rye, Sweet Vernal and Timothy. The five
grass pollens contained in Oralair represent those to which most
patients in the U.S. are exposed.
Oralair is indicated as immunotherapy for the treatment of grass
pollen-induced allergic rhinitis for any of the five grass species
contained in this product. Oralair has been approved based on
results from an extensive clinical development program and has been
studied in double-blind, placebo-controlled trials in Europe and
the United States in over 2,500 adults and children. The results of
these trials demonstrated that pre-seasonal and co-seasonal
treatment reduces patients' allergy symptoms and their need for
symptom-relieving medication (Oralair is not indicated for
immediate relief of allergy symptoms). In the clinical development
program, the most common adverse reactions for Oralair (reported in
=5% of patients) were oral pruritus, throat irritation, ear
pruritus, mouth edema, tongue pruritus, cough and oropharyngeal
pain.
1https://acaai.org/allergies/types/hay-fever-rhinitis
To support administration of Oralair in the pediatric
population, an open-label study was conducted to evaluate the
30-day safety profile of Oralair in 307 children five through nine
years of age. Adverse reactions reported at an incidence of =2%
were: throat irritation (22.1%), oral pruritus (11.7%), oral
paresthesia (11.1%), tongue pruritus (8.1%), mouth edema (6.2%),
cough (6.2%), oropharyngeal pain (4.2%), ear pruritus (5.2%), eye
pruritus (4.6%), lip edema (3.3%), vomiting (2.6%), tongue edema
(2.3%), abdominal pain (2.3%), oral discomfort (2.3%), and ocular
hyperemia (2.0%).
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global
healthcare company specialising in the diagnosis and treatment of
allergies through the development and commercialisation of allergy
immunotherapy products and services. Stallergenes Greer plc is the
parent company of GREER Laboratories, Inc. (whose registered office
is in the US) and Stallergenes SAS (whose registered office is in
France).
TRADING INFORMATIONName: Stallergenes GreerISIN: GB00BZ21RF93 1
- Ticker: STAGRICB Classification: 4577LEI:
213800CYVZA7GJQEME86Market: Euronext Paris regulated market
Additional information is available at
http://www.stallergenesgreer.com.
This document (including information incorporated by reference
in this document), oral statements made, and other information
published by the Company contain statements that are or may be
forward-looking with respect to the financial condition and/or
results of operations and businesses of the Company. These
statements can be identified by the use of forward-looking
terminology such as "believe," "expects," "project," "estimated,"
"forecast," "should," "plan," "may" or the negative of any of
these, or other variations thereof, or comparable terminology
indicating expectations or beliefs concerning future events. These
forward-looking statements include risk and uncertainty because
they relate to events and depend on circumstances that will occur
in the future. Without being exhaustive, such factors include
economic situations and business conditions, including legal and
product evaluation issues, fluctuations in currencies and demand,
and changes in competitive factors. These and other factors are
more fully described in the Company's 2017 annual report published
on 16 April 2018 on the Company's website
www.stallergenesgreer.com. Actual results may differ from those set
forth in the forward-looking statements, due to those and other
factors. Save as required by applicable law, neither the Company
nor any other person assumes any obligation to update these
forward-looking statements or to notify any person of any such
update.
Communications and Investor RelationsCaitlin StefanikTel: +1
(857) 331 4117Email: caitlin.stefanik@stallergenesgreer.com
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(END) Dow Jones Newswires
November 14, 2018 02:00 ET (07:00 GMT)
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