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Home Industry News SkyePharma issues update on Flutiform in Europe

SkyePharma issues update on Flutiform in Europe

8th July 2008

SkyePharma has issued an update on the development of Flutiform in Europe.

It noted plans by Mundipharma – the firm responsible for the clinical development of the drug for regulatory approval in Europe – to review the filing and marketing of the drug following discussions with its advisers and authorities.

Mundipharma had planned to file for approval for the lower and middle strength doses by the end of the year, with a submission for the higher strength dose following further studies, though it is now considering a single joint application in the third quarter of 2009.

The company also reported positive results from a recent paediatric trial of the compound

Frank Condella, chief executive officer of SkyePharma, said: “We are pleased with the progress being made with the approved products and the development of Flutiform, which continues to meet all its development milestones.”

He added that the progress of Flutiform offers a solid platform for the company to renegotiate or refinance its convertible bonds.

Bloomberg reported that shares in SkyePharma fell to their lowest level in 15 years after the announcement that it would try to renegotiate its convertible bonds with its original proposal being unworkable.

The share price for the firm dropped by 13 per cent to 4.75 pence at 08:08 BST.

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