Stallergenes Greer Reports Positive Phase II Japanese Cedar Immunotherapy Tablets Results

Regulatory News:

Stallergenes Greer plc (the "Company”) (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced its partner, Shionogi & Co. Ltd., reported positive results for the phase II clinical study of its sublingual immunotherapy tablet for the treatment of seasonal allergic rhinitis induced by Japanese Cedar pollen (STAGR120).

Conducted in Japan, the study achieved its primary efficacy endpoint with all treated groups demonstrating a positive, statistically significant difference on the Average Rhinoconjunctivitis Total Symptom Score (ARTSS) versus the placebo group. Overall, the safety profiles were favorable.

"The outcome of this study marks an important step forward in the clinical development of our Japanese Cedar Pollen sublingual immunotherapy tablet. We are encouraged by these positive results and look forward to further investigating this therapeutic candidate in a Phase III clinical trial for the benefit of a great number of patients suffering from Japanese Cedar allergies, which are a major health concern in Japan” stated Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer.

In September 2010, Stallergenes signed exclusive partnership agreements with Shionogi & Co., Ltd. for the clinical development, registration and commercialization of sublingual house dust mite and Japanese cedar pollen immunotherapy tablets. As part of this, the Company is eligible to development, regulatory and sales milestones, as well as royalty payments on net sales.

ABOUT THE PHASE II STUDY OF JAPANESE CEDAR POLLEN TABLET (STAGR120)

This was a randomized, double-blind, placebo-controlled, dose ranging trial in an environmental challenge chamber (EEC) to assess the efficacy and safety of Japanese Cedar Pollen sublingual immunotherapy tablets for the treatment of seasonal allergic rhinitis – the first ever in Japan. Patients aged 12 to 49 years with medical history consistent with Japanese Cedar Pollen-induced allergic rhinitis were eligible. A total of 330 patients were randomized to receive four months of treatment with Japanese Cedar Pollen sublingual immunotherapy tablets or placebo.

The Primary efficacy endpoint was the Average Rhinoconjunctivitis Total Symptom Score (ARTSS) after four months of treatment. The ARTSS includes six symptom scores (sneezing, nasal discharge, nasal obstruction, itchy nose, watery eyes and itchy eyes).

All active dose groups showed a significant reduction in the six nasal and ocular symptom score, compared to placebo. Local adverse reactions were observed, most of them were mild in severity. No unexpected adverse events were observed.

ABOUT SEASONAL ALLERGIC RHINITIS INDUCED BY JAPANESE CEDAR POLLEN IN JAPAN

Seasonal allergic rhinitis caused by Japanese cedar pollen (i.e. sugi-pollinosis) is the most common allergic disease in Japan and has been considered a national health issue. More than one third of all Japanese persons have sugi-pollinosis, and this number has significantly increased in the last 2 decades¹. Allergic symptoms are mainly nasal symptoms such as sneezing, rhinorrhea, and nasal congestion, and patients with sugi-pollinosis (seasonal AR caused by Japanese cedar) often wear protective facemasks during spring.

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 U.S.) and Stallergenes S.A.S. (whose registered office is in France).

Trading information:

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

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 our prospectus filed with the French Autorité des marchés financiers on September 3, 2015. 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.

¹ Yamada, Saito, Fujieda, "Present state of Japanese cedar pollinosis: the national affliction”, J Allergy Clin Immunol. 2014 Mar;133(3):632-9.e5. doi: 10.1016/j.jaci.2013.11.002. Epub 2013 Dec 19.

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