SkyePharma is celebrating after its commercial partners scored regulatory approvals in Japan for two asthma drugs.
The Japanese Ministry of Health, Labour and Welfare (MHLW) cleared GlaxoSmithKline’s (GSK) Relvar Ellipta (vilanterol and fluticasone), as well as Kyorin Pharmaceutical’s Flutiform (formoterol and fluticasone) for the treatment of bronchial asthma patients who need both a corticosteroid and beta agonist to control symptoms.
SkyePharma stands to receive single-digit royalties on the sale of both products, capped at £6m a year in the case of the Relvar Ellipta, as well as a milestone payment of “several million dollars” from Kyorin. Shares in the UK-based company were on the rise this morning on the back of the news, up 16 per cent at the time of writing.
Relvar Ellipta is known as Breo in the US, where it was approved for marketing as a treatment for chronic obstructive pulmonary disease (COPD) but not asthma in May.
Japan is the first country to approve the drug for asthma, an important development given that GSK wants to position the product as a successor to its $8bn-a-year Advair/Seretide (salmeterol/fluticasone) asthma and COPD treatment, which is facing the onset of generic competition.
SkyePharma developed technology underpinning the Ellipta dry powder inhaler (DPI) used in Relvar, which is being co-developed by GSK and Theravance. GSK said it stands to receive a $10m milestone payment from Theravance as a result of the Japanese approval of Relva Ellipta.
GSK also said this week it had received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending that Relvar Ellipta be approved for use in the treatment of both asthma and COPD.
Meanwhile, the Flutiform approval in Japan follows the launch of the asthma drug in Europe last year by Swiss drugmaker Mundipharma, and reinforces the recovery of the franchise in the wake of the US FDA’s rejection of the drug in 2010 and the subsequent loss of a marketing partnership with Abbott (now AbbVie).
Mundipharma said this week it has started a 1,500-patient international clinical trial of Flutiform in COPD that aims to show its superiority to formoterol monotherapy, an indication which could add an estimated $500m or more to peak sales of the drug, driving the product above the $1bn blockbuster threshold.