Japan approves COPD, asthma drugs

Japan's Ministry of Health, Labor and Welfare (MHLW) approved three pulmonary drugs Friday, including Relvar Ellipta fluticasone furoate/vilanterol from Theravance Inc. (NASDAQ:THRX) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat bronchial asthma. On Thursday, the partners said EMA's CHMP backed approval of the product treat asthma and chronic obstructive pulmonary disease (COPD). The product is a once-daily, fixed dose combination of the inhaled corticosteroid fluticasone furoate and a long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler. SkyePharma plc (LSE:SKP), which licensed its dry powder formulation technologies for inhalation products to GSK, is eligible for royalties on Relvar Ellipta. Theravance gained $0.90 to $42.10 on the day (see BioCentury Extra, Sept. 9).

MHLW also approved Ultibro indacaterol/glycopyrronium bromide inhalation capsules delivered via the Breezhaler device from Novartis AG (NYSE:NVS; SIX:NOVN) to treat COPD. The approval triggered $2.5 million milestone payments to partners Vectura Group plc (LSE:VEC) and Sosei Group Corp. (Tokyo:4565) from the pharma under a 2005 deal. The product is a fixed-dose combination of glycopyrronium bromide ( NVA237), an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). EMA's CHMP backed approval of the product in July. Novartis plans to submit an NDA to FDA for it by year end. Vectura was off 4.5p to 112.5p on Friday. Sosei was up Y310 to Y5,110. ...