Abbott Laboratories has passed back its U.S. development and marketing rights to the registrational inhaled asthma therapy Flutiform™ to the drug’s original developer, SkyePharma. The latter said no money will change hands as a result of Abbott terminating its agreement for Flutiform.
Whether the fixed-dose formoterol-fluticasone combination therapy will ever be approved in the U.S. is now questionable. FDA’s refusal to sanction the drug in January led SkyePharma to admit that the agency had raised “a number of substantive issues to be addressed, which, if undertaken, would involve significant additional clinical work including work to provide the additional data on dosing.”
Abbott’s decision to give up on Flutiform follows SkyePharma’s meeting with FDA in June to discuss the NDA further. The agency’s conclusions led SkyePharma to state that FDA’s requirements for approving Flutiform had “changed materially during the course of the development program." The firm admitted that meeting these requirements would involve significant new work including a large post-approval safety study.
The firm admits the latest move by Abbott was not unexpected. “We are not surprised that Abbott has decided to terminate its interest in the product,” comments Ken Cunningham, M.D., SkyePharma CEO. Meanwhile, the company appears stoically optimistic about the future for Flutiform in the U.S. “SkyePharma is continuing to investigate whether there is a viable way forward in the U.S., and we have not given up on finding a pathway,” Dr. Cunningham stresses. “If there is a way forward, the group would seek a new U.S. licensee with strategic interest in the product and which would finance any additional clinical work required.”
SkyePharma has previously stressed that FDA reluctance to approve Flutiform should have no impact on the ongoing regulatory evaluation in Europe, where the firm has partnered commercialization of the drug with Mundipharma Europe. Flutiform is currently undergoing Phase II trials in Japan in collaboration with partner Kyorin Pharmaceutical.