SkyePharma has been boosted by the news that enrolment for two late-stage studies to assess efficacy and safety of the asthma combo Flutiform has commenced in Japan.
The two Phase III trials, which the company says “will provide clinical data to support the regulatory process in Japan” for Flutiform (fluticasone/formoterol), are being carried out with partner Kyorin. Under that agreement, the development costs associated with obtaining approval for the Japanese market will largely be met by Kyorin.
SkyePharma chief executive Axel Muller said the development programme for Flutiform in Japan is progressing quicker than anticipated, describing Japan as an “important and growing market”. The company added that it continues to make preparations for a potential launch in Europe in 2011 for the combo, which was rejected earlier this year by the US Food and Drug Administration.
Analysts at Singer Capital Markets said news of the Japanese trials is positive. In a research note, Shawn Manning and Elizabeth Klein noted that if the Phase III trials are successful, “we assume that regulatory filing could be completed over 2013-14, with approval by 2015-16”.
They expect Kyorin to pay small milestones on filing and approval ($3 million and $4 million respectively), and a high mid-single digit (possibly 7%) royalty on sales. The analysts said that the Japanese respiratory market is significant, with asthma sales in excess of $1.0 billion.
There is some heavyweight competition waiting for Flutiform, however. Both
GlaxoSmithKline’s Advair (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide and formoterol) are marketed in Japan (launched in 2007 and 2009 respectively), the latter co-promoted by Astellas Pharma. Singer estimates that combined annual sales of these two products currently exceeds $200 million in Japan.
