Stallergenes Greer plc Stallergenes Greer Announces Approval in Japan of Pediatric Use for ACTAIR®, Sublingual Immunotherapy...
16 February 2018 - 6:00PM
UK Regulatory
TIDM0RB9
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company
specializing in treatments for respiratory allergies, today
announced that its partner in Japan, Shionogi & Co. Ltd.,
received approval for the extension of the indication for ACTAIR®,
an allergy immunotherapy sublingual tablet for the treatment of
house dust mite (HDM) induced allergic rhinitis, to treat patients
under the age of 12. ACTAIR is already approved for the treatment
of HDM-induced allergic rhinitis in patients 12 years of age and
older in Japan since March 2015.
"The approval of ACTAIR for pediatric use in Japan will provide
a valuable treatment option for patients under the age of 12
suffering from allergic rhinitis caused by an allergy to house dust
mites. We are very pleased that this product will be available to
even more patients in Japan," said Fereydoun Firouz, Chairman and
CEO of Stallergenes Greer.
The New Drug Application submission was supported by data from
Shionogi's positive Phase III trial, which was announced in January
2017. The multi-center, randomized, double-blind,
placebo-controlled study evaluated the efficacy of ACTAIR at a
daily maintenance dose of 300IR administered for 12 months to
children between 5 and 16 years old with HDM-associated allergic
rhinitis. The active group demonstrated a statistically significant
difference (p=0.0005) versus placebo on the Average Adjusted
Symptom Score after one year of treatment, achieving the primary
efficacy endpoint.
In addition to Japan, Stallergenes Greer's HDM tablet is
registered in Australia, New Zealand and South Korea under the
brand name ACTAIR for the treatment of HDM-induced allergic
rhinitis in patients 12 years of age and older.
Stallergenes Greer has exclusive partnership agreements with
Shionogi for the clinical development, registration and
commercialization of HDM and Japanese cedar pollen sublingual
immunotherapy tablets in Japan.
ABOUT SHIONOGI'S PHASE 3 TRIAL IN CHILDREN 5 TO 11 YEARS OLD
The primary endpoint was the AAdSS over the last month of the
one-year treatment period. The AAdSS is the average of the total
score of four rhinitis symptoms (sneezing, rhinorrhea, nasal
congestion and nasal pruritus) adjusted for rescue medication use.
This was a multi-center, randomized, double-blind,
placebo-controlled study to assess the efficacy of HDM sublingual
immunotherapy tablets for the treatment of allergic rhinitis.
Patients aged 5 to 16 years old with medical history consistent
with HDM-induced allergic rhinitis were eligible. A total of 438
patients were randomized to receive 12 months of treatment with HDM
sublingual immunotherapy tablets or placebo. The active group
showed statistically significant difference (p=0.0005) compared to
placebo. Local adverse reactions were observed, with most of them
mild in nature with no marked safety concerns.
ABOUT RESPIRATORY ALLERGIES IN JAPAN IN PEDIATRIC PATIENTS
Allergic rhinitis affects 25% of Japan's population. House dust
mites and Japanese cedar pollen are the two main causes of
respiratory allergies in the country. From early childhood, house
dust mites can trigger allergic rhinitis, which worsens over time
with a potential progression towards asthma. The symptoms may be
severe, significantly impairing patients' quality of life. With 32
million respiratory allergy sufferers, there is a strong, and as
yet unmet, demand for allergy treatment in Japan.
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global
healthcare company specializing in the diagnosis and treatment of
allergies through the development and commercialization 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 2016 annual report published
on 28 April 2017 on the Company's website
www.stallergenesgreer.com. Actual results may differ from those set
forth in the forward-looking statements, due to various 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.
Stallergenes GreerCommunications and Investor RelationsNatacha
GassenbachTel: +1 (617) 225 8013Email:
natacha.gassenbach@stallergenesgreer.comorInvestor Relations
AgencyFTI ConsultingArnaud de CheffontainesTel: +33 1 47 03 68
10Email: stalleregenesgreer@fticonsulting.comorMedia Relations
AgencyHavas - Paris (Europe)Samuel Rousseau Tel: +33 (0) 6 51 03 51
43Email: samuel.rousseau@havas.com
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(END) Dow Jones Newswires
February 16, 2018 02:00 ET (07:00 GMT)
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