drugset / Press release

First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan

2013-08-26 · Nxera Pharma UK Limited · original nxera.life ↗

1 First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan Tokyo, Japan – 26 August 2013: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that the Drug Committee of MHLW has endorsed approval of once-daily QVA149 (glycopyrronium / indacaterol), developed by Novartis, as a treatment to relieve symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD) in Japan. The Japanese MHLW is expected to follow with approval in due course. In July 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of QVA149 in Europe under the brand name Ultibro® Breezhaler®. Ultibro ® and Breezhaler® are registered trademarks of Novartis AG. -Ends- Enquiries: Sosei Group Corporation Tokyo Office London Office Milica STOJKOVIC, Investor Relations Kathryn LYDON, PA to CEO & Corporate Communication +81-(0)3-5210-3399 +44-(0)20-7691-0983 [email protected] [email protected] About QVA149 QVA149 is an investigational fixed dos e combination of two bronchodilators, glycopyrronium, a long-acting muscarinic antagonist (LAMA) and indacaterol, a long- acting beta2-adrenergic agonist (LABA). About Sosei Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets. For further information about Sosei, please visit www.sosei.com. 2 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 forward- looking 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 competitors. 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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