SkyePharma regains US marketing rights to Flutiform from Abbott

Shares of UK drug formulation specialist SkyePharma (SKP: L) fell by as much as 5% to 38 pence early on Friday ' but recovered to 39 pence by close, after the company said that US drug major Abbott Laboratories (NYSE: ABT) has terminated its agreement to develop the asthma drug Flutiform, (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12 years of age and older. Under the agreement there are no material payments due by either party on termination, the UK firm noted.

As previously announced, following a recent meeting with the US Food and Drug Administration to discuss the Complete Response Letter received in January 2010 in respect of the New Drug Application for Flutiform, SkyePharma is continuing to investigate whether there is a viable way forward for the drug in the USA. The NDA was transferred back to SkyePharma by Abbott earlier this year (The Pharma Letters January 22 and February 8).

The European Marketing Authorization Application for Flutiform, filed in March 2010, remains under regulatory review in Europe, where the regulatory approach is different from the USA, SkyePharma explained, adding that progress continues to be made with the development in Japan, with Phase III studies expected to commence by March 2011.