SkyePharma hit with European delay on Flutiform app

SkyePharma's troubles persisted with its combo asthma product Flutiform, with European regulators unable to meet the drug-delivery specialist's approval timeline. Investors reacted to the news and sent the British drug firm's stock down to an 8-week low on Tuesday, Reuters reported.

Mundipharma, SkyePharma's partner on the treatment for the European market, got word from European regulators that a review process for the product was not completed by their expected date of Oct. 17, after member states could not reach a consensus on the approvability of the treatment by that time, according to SkyePharma's release. To reach a consensus, the review has transitioned to a "referral process" that should take about 90 days to be completed.

SkyePharma has had a rough go with Flutiform, a combination of the long-acting beta agonist formoterol and the steroid fluticasone, which uses the firm's metered dose inhaler (MDI) and formulation technologies. U.S. regulators shot down the firm's application to gain approval of the treatment last year, prompting Abbott Laboratories ($ABT) to cut ties with the product. The delays have also kept SkyePharma's product from taking on GlaxoSmithKline's ($GSK) and AstraZeneca's ($AZN) rival products already on the market.

"We assume that Flutiform will eventually work its way through the somewhat tangled European regulatory process as other products have done," Shawn Manning, an analyst at Singer, told Reuters.

Yet it's looking likely that a European approval won't come until next year.

- here's the release
- read the Reuters article