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SkyePharma’s licensee Abbott Respiratory pulls-out of Flutiform development

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SkyePharma (LON:SKP) is now the sole developer of the Flutiform investigational asthma treatment for adolescents, after its license partner Abbott Respiratory LLC terminated its interest in the product. In the US, regulatory approval process has stalled with the US Food and Drugs Administration (FDA) rejecting the New Drug Application (NDA) in its present form.

The US marketing rights for Flutiform have now reverted back to Sypharma.

Previously, the FDA raised a number of “new substantive issues”, which would involve “significant additional clinical work” to generate more dosage-related data.

"Given the delay in obtaining approval for Flutiform™ in the United States, we are not surprised that Abbott has decided to terminate its interest in the product ... SkyePharma is continuing to investigate whether there is a viable way forward  ... If there is a way forward, the Group would seek a new US licensee”, SkyePharma Chief Exec Dr Ken Cunningham said.

In March 2010, a European Marketing Authorisation Application was filed for Flutiform, and it currently remains under regulatory review.

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