TEL AVIV -- SkyePharma Plc, the London drugmaker, said on Tuesday that Flutiform, an investigational treatment for persistent asthma for people 12 and older, is unlikely to be cleared for marketing in the U.S. before second-half 2011. After meeting with the U.S. Food and Drug Administration, the company confirmed that the drug will need additional clinical work to provide more data on dosing, SkyePharma said. In June, the FDA told the company that it had identified some issues in its preliminary evaluation of SkyePharma's new-drug application, the company said. Under a license accord, Abbott Labs, the Abbott Park, Ill., health-care company, is responsible for funding additional required trials and can recoup the related costs, SkyePharma said. The potential review issues aren't expected to affect the development of Flutiform for Europe or Japan, a process that remains on track, SkyePharma said.

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