Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints

- 1 - Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints Tokyo, Japan – 29 August 2016: Sosei Group Corporation (TSE Mothers Index: 4565) hereby announces that its Japanese subsidiary Sosei Co. Ltd. has completed the Japanese Phase III study of SO-1105 (miconazole 50 mg, muco-adhesive tablet) for the treatment of oropharyngeal candidiasis; meeting the primary endpoint as requested for submission. The study was an open-label, randomized, multi-site, parallel-group, comparative clinical study to investigate the efficacy and safety of SO-1105 in comparison with a commercialized formulation of miconazole in patients with oropharyngeal candidiasis in Japan. The cure rate after the completion of the targeted study medication period with SO-1105 was the same as the comparator in terms of the primary endpoint. In addition, the primary endpoint in the sub-group analysis (cure rate in post-radiotherapy patients with head-and-neck cancer) was similar to the one from overseas clinical studies with SO-1105 in this population. All other efficacy endpoints demonstrated non-differentiation between SO-1105 and the comparator in the Japanese study as well as overseas. Furthermore, the safety of SO-1105 showed a similar profile to the comparator. SO-1105 is an antifungal agent administered for the first time in Japan as a once-daily muco- adhesive tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients. It has the potential to offer a new treatment option, as release of the active component is local and sustained thereby increasing the convenience for patients. Loramyc® (SO-1105 in Japan) was developed by Onxeo SA (referred to hereafter as “Onxeo”), formerly known as BioAlliance Pharma SA. The product is commercialized in the US under the name of Oravig® and in Europe under the name of Loramyc®. The technology used for SO-1105, called Lauriad™, has been developed to provide high concentrations of the active ingredient directly at the site of infection. Sosei Co. Ltd. obtained the exclusive marketing rights for SO-1105 in Japan from Onxeo in May 2011 and has already entered into an exclusive contract for marketing and commercialization with Fujifilm Pharma Co., Ltd. Sosei Co. Ltd. is currently preparing the application for approval of SO-1105. - Ends – Enquiries: Sosei Group Corporation Tokyo Office London Office Harumi BANSE Investor Relations Kathryn LYDON, Corporate Communications +81-(0)3-5210-3399 +44-(0)20-7691-0983 [email protected] [email protected] - 2 - Notes to Editors Oropharyngeal candidiasis [1, 2] Oropharyngeal candidiasis is a fungal infection caused mainly by Candida albicans. It occurs most frequently in patients who are immunocompromised due to HIV, malignant tumors, etc. There are various clinical forms of oropharyngeal candidiasis including pseudomembranous candidiasis, and erythematous (atrophic) candidiasis. Symptoms include tongue pain, burning sensation, dysgeusia, and dysphagia, and signs include white moss, erythema, and angular cheilitis. With the aging population, and improvements in medical techniques, the frequency of candidiasis is increasing. About Sosei Sosei Group Corporation is an international biopharmaceutical company originating from Japan that discovers and develops innovative biopharmaceuticals for the treatment of Alzheimer's disease, schizophrenia, cancer, migraine, addiction, metabolic disease, and other indications. By utilizing its GPCR structure-based drug design platform technology, Sosei have established a product pipeline with first/best in class potential. Through development and commercialization partnerships, Sosei have already delivered two bronchodilators for COPD which generate significant and stable revenue streams that enable further growth. Sosei partners include Novartis, Allergan, AstraZeneca, MedImmune, MorphoSys, Teva, and Pfizer and we are actively looking for new partnerships to enhance the development of our products and help us deliver them to patients worldwide. For further information about Sosei, please visit http://www.sosei.com/en/. About Onxeo Onxeo is a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, driven by high therapeutic demand in one of the fastest growing segments of the pharmaceutical industry. Onxeo’s objective is to become a major international player in the field of rare cancers. Its growth strategy is founded on the development of innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in the treatment of orphan oncology diseases and considerably improve the quality of life of patients affected by rare and aggressive cancers. Onxeo’s comprehensive portfolio features a broad orphan oncology pipeline, with four independent programs in various stages of clinical development, including Onxeo’s first approved orphan oncology drug, Beleodaq®. The Company is headquartered in Paris, France and has approximately 50 employees. Onxeo is listed on Euronext in Paris, France (Ticker: ONXEO, ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark (Ticker: ONXEO). For further information about Onxeo, please visit http://www.onxeo.com/. 1. Hideyo Yamaguchi: Pathogenic Fungi and Fungal Diseases (rev. ed. 4), Nankodo, Tokyo, 2007, pp. 238-239. 2. Committee for Establishing Guidelines for Oral Candidiasis Pharmacotherapy, Japanese Society of Oral Therapeutics and Pharmacology (ed.): Guidelines for Oral Candidiasis Pharmacotherapy: Fundamentals and Clinical Practice for Medical Treatment and Care (ed. 1), Ishiyaku Publishers, 2016, pp. 1-5.

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