Commencement of First Phase III Trial of Inhaled Triple Therapy QVM149 for Asthma

1 Commencement of First Phase III Trial of Inhaled Triple Therapy QVM149 for Asthma Tokyo, Japan - 9 December 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the commencement by Novartis of the first Phase III trial of QVM149, a new inhaled triple therapy for asthma. QVM149 is a fixed dose, once daily combination of the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide, the long-acting beta 2-agonist (LABA) indacaterol, and the inhaled corticosteroid (ICS) mometasone fuorate. The Phase III trial is conducted in patients with moderate to severe asthma uncontrolled by standard ICS/LABA medication. Glycopyrronium bromide was licensed exclusively to Novartis in April 2005 by Sosei and its co-development partner Vectura. Enrolment of the first patients into the trial programme now triggers the receipt of a milestone payment to Sosei of $3.75m under the terms of the Licence Agreement. First regulatory filings of QVM149 are planned for 2018. -Ends- Enquiries: Sosei Group Corporation Tokyo Office London Office Harumi Banse Corporate Communications Kathryn LYDON, Corporate Communications +81-(0)3-6679-2095 +44-(0)20-7691-0983 [email protected] [email protected] About Asthma Asthma is characterized by variable symptoms of wheeze, shortness of breath, chest tightness and/or cough and by variable expiratory airflow limitation. Risk factors for developing asthma include allergens, viruses tobacco smoke and chemical irritants. In many patients symptoms may resolve s pontaneously or in response to medication, however continued exposure to allergens may lead to worsening of symptoms. Persistent symptoms can trigger inflammatory responses in the airways and can deteriorate the condition.1 Some 235 million people, both children and adults, currently suffer from asthma.2 2 About Sosei Sosei Group Corporation is an internationa l 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 platform technologies - GPCR st ructure-based drug design platform technology, peptide platfo rm technologies and nanotechnology - Sosei have established a product pipeline with first/best in class potential. Through development and commercialization partnerships Sosei have already delivered three medicines to the market (two COPD bronchodilators and an emergency contraceptive), which generate significant and stable revenue streams that enable further growth. Sosei Group partners include Novartis, AstraZeneca, MedImmune, Cubist, MorphoSys, Takeda, 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. Reference: 1. Global Strategy for Asthma Management and Prevention, 2015 update. (http://www.ginasthma.org/) 2. WHO Fact sheet N o 307 (http://www.who.int/mediacentre/factsheets/fs307/en/) # # # Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Sosei’s actual results to differ materially from those expressed or implied by the forwardlooking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitor s. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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