UPDATE 1-SkyePharma trims H1 loss, meeting FDA on Flutiform

Fri Aug 21, 2009 3:11am EDT

* H1 net loss of 6.1 mln pounds vs 6.8 mln year ago

* Meeting agreed with FDA on Flutiform drug delay

* Tight cash control to ensure sustainable profitability (Adds details, background)

LONDON, Aug 21 (Reuters) - British drug delivery specialist SkyePharma (SKP.L) trimmed first-half losses on lower revenue and said it remain confident about its key new lung drug Flutiform, despite a delay in the United States.

A meeting has been arranged with the U.S. Food and Drug Administration (FDA) to discuss what extra information the regulator needs to complete the review of Flutiform, the company said on Friday.

SkyePharma posted a net loss of 6.1 million pounds ($10.1 million) in the six months to June 30, down from 6.8 million a year ago. Revenue fell as expected, down 10 percent to 25.5 million, and the group had cash reserves of 23.8 million at the end of the period.

Chief Executive Ken Cunningham said it would continue to control cash tightly to ensure the cash position remained sufficient to achieve sustainable profitability. The group is also actively seeking partners for its SkyeHaler DPI technology.

SkyePharma suffered a setback in June when the U.S. Food and Drug Administration raised issues about its application to market Flutiform, delaying approval of the company's flagship product.

"We are aiming to address these (issues) as quickly as possible, and we remain confident in the potential for Flutiform in the U.S. and other key markets," Cunningham said.

SkyePharma is partnering on Flutiform with Abbott Laboratories (ABT.N) in the United States and with Mundipharma in Europe.

If approved, Flutiform will compete with two big and well-established fixed-dose asthma combination drugs -- GlaxoSmithKline's (GSK.L) market-leading Advair and AstraZeneca's (AZN.L) Symbicort.

For the second half, SkyePharma said overall revenues were expected to be similar to those reported in the first half, adding it would benefit from cost reductions already implemented and the effect of agreed price increases for some products. ($1=.6054 Pound) (Reporting by Ben Hirschler, editing by Will Waterman)

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