Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, announces that the regulatory committee (Bunka-Kai) of the Japanese Ministry of Health, Labour and Welfare (“MHLW”) has approved RELVARTM ELLIPTATM (FF/VI) for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long- acting inhaled beta2 agonist is required). RELVARTM ELLIPTATM is not indicated for the treatment of Chronic Obstructive Pulmonary Disease (“COPD”) in Japan. RELVARTM ELLIPTATM is a combination product submitted by GlaxoSmithKline (“GSK”) for the long-term, once-daily maintenance treatment of bronchial asthma.
RELVARTM ELLIPTATM combines the inhaled corticosteroid (“ICS”) fluticasone furoate with the long- acting beta agonist (“LABA”) vilanterol and incorporates one of the Group’s proprietary dry powder formulation technologies for inhalation products licensed to GSK. This medicine has also been approved for the treatment of COPD in the United States, under the name BREOTM ELLIPTATM, where launch activities are expected to begin in Q3/Q4. BREOTM ELLIPTATM is not indicated for the relief of acute bronchospasm or for the treatment of asthma in the United States.
Skyepharma 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 per annum for each chemical entity for the life of the relevant patents. RELVARTM ELLIPTATM contains two chemical entities. RELVARTM ELLIPTATM was filed for approval in Europe in June 2012.
The technology has also been incorporated in another investigational combination product, with a proposed brand name of ANOROTM ELLIPTATM (umeclidinium bromide/vilanterol) that contains two chemical entities, one of which is common to both RELVARTM ELLIPTATM and ANOROTM ELLIPTATM. NDAs (new drug applications) for ANOROTM ELLIPTATM have been filed for approval across the world, including the United States, Europe and Japan. On 10 September 2013, an FDA Advisory Committee of the Pulmonary-Allergy Drugs Division recommended approval of ANOROTM ELLIPTATM in the United States for the treatment of COPD and the Prescription Drug User Fee Act (“PDUFA”) target date is 18 December 2013. The investigational medicine was filed for approval in Europe and Japan in January and April 2013 respectively. This medicine is not approved or licensed anywhere in the world.
RELVARTM, BREOTM, ANOROTM and ELLIPTATM are trademarks of the GlaxoSmithKline group of companies. The use of the brand name ANOROTM is not approved by any regulatory authorities.