UPDATED: SkyePharma's Flutiform launches in Germany, U.K.; Kyorin seeks OK in Japan

U.K.-based SkyePharma's Flutiform, an inhaled combination of fluticasone and formoterol, has been launched in Germany by the company's partner, Mundipharma, as an asthma maintenance therapy. SkyePharma will receive a milestone payment of €4 million ($5.1 million).

Mundipharma has also launched the inhaler in the U.K., and these two market entries followed the European Commission decision in favor of granting marketing authorization in July. Flutiform is also approved in Austria, Cyprus, the Netherlands, Norway, the Slovak Republic and Sweden, and Mundipharma is planning launches those countries "as soon as possible," according to SkyePharma.

Hot on the heels of this announcement, SkyePharma's development and marketing partner Kyorin Pharmaceutical has filed an NDA for marketing approval with the Japanese authorities, based on data from the European application as well as two Japanese Phase III trials.

Japan has about 8.5 million asthma patients, and if the inhaler is approved in Japan, SkyePharma will receive a milestone payment of several million U.S. dollars as well as undisclosed mid-single-digit percentage royalties.

Flutiform's road to the market has not been smooth, however--European approval was recommended in April, and finally granted in July, after the inhaler failed to get a unanimous vote in 2011. In 2010, the FDA rejected the combination's marketing submission, resulting in the loss of a license agreement with Abbott Labs ($ABT).

The aerosol inhaler uses SkyePharma's proprietary SkyeDry technology, and this is the first time these two drugs have been available as a combination in Europe, says SkyePharma CEO Peter Grant.

- read the press release on the German launch
- check out the press release on the U.K. launch
- see the press release on the Japanese submission

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Editor's note: This story updates with information on the U.K. launch.