LONDON--(BUSINESS WIRE)--Regulatory News:
Stallergenes Greer plc (Euronext:STAGR) today announced the launch in Japan of Actair® (STG320), the first immunotherapy tablet for the treatment of House Dust Mite (HDM)-induced allergy in adolescents and adults, by Shionogi & Co., Ltd.. Actair® has been developed by Stallergenes Greer who has granted an exclusive license to Shionogi & Co., Ltd. for Japan.
Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer plc, said:
“We are delighted about the launch of Actair® in Japan, which marks a key milestone for Stallergenes Greer, as it is the first launch worldwide for a house dust mite allergy immunotherapy tablet. This launch is a further proof of our successful long-term collaboration with Shionogi & Co., Ltd., as well as our worldwide leadership in the allergy immunotherapy HDM segment. This marks a significant step for our globalization strategy and the roll-out of our portfolio.”
Since September 2010, Shionogi & Co., Ltd. has been the exclusive partner of Stallergenes Greer for the clinical development, registration, marketing and sales of sublingual HDM immunotherapy tablets and sublingual Japanese cedar pollen immunotherapy tablets in Japan. Stallergenes Greer will receive payments on sales of Actair® in Japan.
In addition, Shionogi & Co., Ltd. has started a phase III trial to evaluate the efficacy and safety of Actair® in allergic rhinitis in children (5 to 16 years of age).The trial is expected to enroll approximately 400 subjects.
ABOUT RESPIRATORY ALLERGIES IN JAPAN
Allergic rhinitis affects 25% of Japan’s population. HDM and Japanese cedar pollen are the two main causes of respiratory allergies in this country. From early childhood, HDM can trigger allergic rhinitis, which worsens over time with a natural 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 where sublingual allergen immunotherapy tablets have not been available.
ABOUT ACTAIR® (STG320) HDM TABLET
With a unique galenic form and tailored to the sublingual route, Actair® (STG320) is a sublingual immunotherapy tablet consisting of D.pte/D.far purified and calibrated HDM extracts corresponding to the epidemiological characteristics of patient exposure. Actair® is indicated for the treatment of HDM allergic rhinitis, confirmed by clinically relevant symptoms, a positive cutaneous test for HDM allergies and/or a positive test for the specific IgE to HDM.
Actair® (STG320) has been the subject of a phase II / III clinical study in Japan (1501D1732). This randomized, double-blind and placebo-controlled study has evaluated the efficacy and safety of a 12 month course of treatment with sublingual HDM immunotherapy tablets. On 3 February 2014, Shionogi reported that the study met its primary efficacy endpoint, as each of the active treatment groups demonstrated a statistically significant difference on the Average Adjusted Symptom Score after one year of treatment versus the placebo group. Overall, the safety and tolerability profile were favorable.
Shionogi & Co., Ltd. has announced it has received the approval of Actair® (STG320) from the Japanese health authorities (PMDA - Pharmaceuticals and Medical Devices Agency) on 30 March 2015.
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global 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 U.S.) and Stallergenes S.A.S. (whose registered office is in France).
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com
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