Shares in UK-based drugmaker SkyePharma were hit before the weekend on news that US drug giant Abbott has walked away from its license and marketing agreement for Flutiform.
SkyePharma’s stock took a downturn on Friday after it announced it had regained the marketing rights to Flutiform (fluticasone and formoterol), which has seen its path to approval beset with setbacks across the pond, after Abbott terminated the groups’ US development, license and marketing agreement.
The US Food and Drug Administration rejected the New Drug Application for Flutiform as a treatment for asthma in January, and following a 74-page complete response letter from the Agency in June SkyePharma admitted “it appears likely that some additional clinical work may be required to provide more data on dosing”.
On news of Abbott’s retreat, SkyePharma’s chief executive Ken Cunningham, said it was not surprising given the delay in obtaining approval for Flutiform in the US, but he stressed that the firm is “continuing to investigate whether there is a viable way forward…and we have not given up on finding a pathway”.
But Abbott’s termination of the deal will come undoubtedly come as a blow to the firm, given that the success of Flutiform is critical to its future and that additional clinical trials can be expensive. However, if there is a way forward, the said it group will seek a new US licensee with strategic interest in the product, “and which would finance any additional clinical work required”.
Flutiform is also currently being assessed by regulators in Europe, “which remains a very big market for inhaled combination products for asthma,” the company noted.