drugset / Press release

ROVI announces the agreement to market Hirobriz Breezhaler y Ulunar Breezhaler en España

2013-11-26 · Rovi Pharmaceuticals Laboratories · original rovi.es ↗

ROVI – Commercialization of Hirobriz® and Ulunar® in Spain 1 For further information: Investor Relations (Tel: +34 91 244 44 22) Marta Campos Martínez [email protected] Virginia Pérez Repes [email protected] ROVI announces the agreement to market Hirobriz ® Breezhaler ® and Ulunar ® Breezhaler ® in Spain Madrid, 26 November 2013 – Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or “the Company”) announces it has signed an agreement with Novartis Farmacéutica, S.A. for marketing Hirobriz ® Breezhaler ® (Indacaterol maleate) and Ulunar ® Breezhaler ® (indacaterol maleate and glycopyrronium bromide) i n Spain, which correspond to Novartis’ Onbrez ® Breezhaler ® and Ultibro ® Breezhaler ® products respectively. Under the terms of this marketing agreement, ROVI w ill undertake the promotion and distribution in Spain both of Hirobriz Breezhaler, whose active ingredient is indacaterol maleate, and of Ulunar Breezhaler, which combines i ndacaterol maleate and glycopyrronium bromide. Both products are inhaled b ronchodilators for patients with respiratory difficulties due to a pulmonary disease known as Chronic Obstructive Pulmonary Disease (COPD). Indacaterol maleate delivered through the Breezhale r device is indicated for maintenance bronchodilator treatment of airflow obs truction in adult patients with COPD. Indacaterol belongs to a group of bronchodila tor drugs called beta2-adrenergic agonists, which, when inhaled, relax the small airw ay wall muscles of the lungs, helping to open the airways and ease the inflow and outflow of air. The combination of indacaterol maleate and glycopyrronium bromide delivered through the Breezhaler device is the first once-daily dual bronchodilator for the maintenance ROVI – Commercialization of Hirobriz® and Ulunar® in Spain 2 treatment of COPD to be approved both in Europe and in Japan. It is expected that dual bronchodilation will set a new standard of care for COPD by combining the proven efficacy benefits and safety profiles of two establ ished treatments for COPD: indacaterol maleate and glycopyrronium bromide. Hirobriz Breezhaler is already marketed in Spain, and ROVI will begin promoting it from 1 January 2014. Rovi expects to market the combinat ion of indacaterol maleate and glycopyrronium bromide delivered through the Breezhaler device by beginning 2015. According to IMS Health data, during the twelve mon ths to September 2013 (MAT September 2013) market sales of inhaled beta 2 stim ulants (which include Hirobriz Breezhaler) stood at 39.7 million euros. There are no sales figures in the case of the combination, since it had not yet begun to be marke ted in Spain, but the market for anticholinergics (alone and in combination), to whi ch these products will belong, amounts to 156.6 million euros in Spain (MAT September 2013). Juan López-Belmonte Encina, ROVI’s Chief Executive Officer, commented: “We are very excited about the potential of Hirobriz Breezh aler and Ulunar Breezhaler”. Both, indacaterol maleate and its combination with glycop yrronium bromide used with the Breezhaler device were shown to provide benefits in pulmonary function and respiratory activity, thereby improving COPD patients’ quality of life. In addition, these products are of high strategic value and we expect them to contribute to the Group’s revenue in the next few years, strengthening our pr oduct portfolio in the area of pharmaceutical specialities.” About ROVI ROVI is a fully integrated Spanish specialist pharm aceutical company dedicated to research, development, manufacture under license an d marketing of small molecules and biological specialities. The Company has a diversified portfolio of products which it has been marketing in Spain through a specialist sa les team, devoted to visiting medical specialists, hospitals and pharmacies. ROVI ’s portfolio, with 30 main products marketed, is currently focused on its flagship prod uct, Bemiparin, a second-generation low-weight heparin developed internally. ROVI’s pro duct portfolio in the research and development phase is mainly focused on meeting medi cal needs that are currently ROVI – Commercialization of Hirobriz® and Ulunar® in Spain 3 unsatisfied; developing new products based on low-molecular-weight heparins (LMWH) and expanding the indications for existing products also based on LMWH. ROVI manufactures the active ingredient Bemiparin for it s main patented products and for the injectable pharmaceutical products developed by its own team of researchers, and uses its filling and packaging capacity to offer a wide range of third-party manufacturing services for some of the leading inte rnational pharmaceutical companies, mainly in the area of preloaded syringes . For further information, visit www.rovi.es .

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