Shares in Skyepharma (LON:SKP) fell by 5% to 38p this morning on confirmation that drugs giant Abbott (NYSE:ABT) was handing back the US marketing rights to Flutiform, an investigational treatment for persistent asthma in patients 12 years of age and older. The moves comes after the US Food & Drug Administration (FDA) rejected a New Drug Application for Flutiform in January this year. In a follow up meeting held in June, the agency reiterated that it could not approve the NDA in its present form and it apparently became clear that the FDA's requirements for approving Flutiform had changed materially during the course of the development programme SkyePharma said that meeting those requirements would involve significant additional work including generating additional data on dose ranging and a large post-approval safety study.

SkyePharma said it was continuing to investigate whether there was a viable way forward for Flutiform in the US. If that turns out to be the case, the group said it would seek a new US licensee with strategic interest in the product and which would finance any additional clinical work required. A European Marketing Authorisation Application for Flutiform, filed in March 2010, remains under regulatory review in Europe, where the regulatory approach is different from the US, and progress continues to be made with the development in Japan, with Phase III studies expected to begin by March 2011.

Dr Ken Cunningham, SkyePharma’s chief executive, said: “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. However, SkyePharma is continuing to investigate whether there is a viable way forward in the United States, and we have not given up on finding a pathway. If there is a way forward, the group would seek a new US licensee with strategic interest in the product and which would finance any additional clinical work required. In the meantime, Flutiform is under review in Europe, which remains a very big market for inhaled combination products for asthma.”

Unlock the rest of this article with a 14 day trial

Unlock with Email
Unlock with Google

Already have an account?
Login here