Shares in SkyePharma were given a boost by news that its flagship asthma therapy Flutiform is a giant leap closer to securing an approval in Japan.
The group’s stock closed up more 16% after it emerged that the Pharmaceutical Affairs and Food Sanitation Council’s Second Committee on Drugs, of the Japanese Ministry of Health, Labour and Welfare (MHLW), has recommended approval of Flutiform for bronchial asthma treatment in the country.
In Japan the product is licensed to Kyorin Pharmaceutical Co, which will pay SkyePharma several millions of dollars on receipt of a full regulatory nod, as well as high-mid single digit royalties on subsequent net sales.
The new drug application will now be considered by the MHLW’s regulatory committee for official authorisation and, if successful, will make Flutiform the first product in Japan the fast acting LABA (long-acting beta agonist), formoterol, and the inhaled corticosteroid fluticasone.
The regulator is also considering pricing for the National Health Insurance drug price list, which must be agreed prior to any launch, SkyePharma said.
