Japanese approvals for GSK, Kyorin/Skyepharma, Novartis/Vectura and Takeda

UK pharma major GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) announced this morning that the regulatory committee of the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Relvar Elvar (FF/VI) for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required).

Relvar Elvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2 agonist (LABA), vilanterol “VI”. The MHLW has approved two doses of FF/VI – 100/25mcg and 200/25mcg. Both strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI).

Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $10 million to GSK following MHLW approval of Relvar Ellipta in Japan. UK drug delivery specialist Skyepharma (LSE: SKP) is entitled to a low single digit royalty on net sales of products using the licensed technology, capped at a maximum amount of £3.0 million ($4.8 million) per annum for each chemical entity for the life of the relevant patents.