SkyePharma shares rose 10% on the news that the US Food and Drug Administration has given the green light to the firm's asthma inhaler Foradil Certihaler for the treatment of asthma.
The FDA issued only an approvable letter in April 2006 for Foradil Certihaler (formoterol fumarate) due to concerns, highlighted by recalls of the product in Germany and Switzerland, that accidental mishandling of the device may have resulted in inaccurate dosing in a small number of cases. However the device was modified and the agency has given the changes the thumbs-up.
SkyePharma's chief executive Frank Condella said that "we are extremely pleased by the FDA's decision to approve the modifications to Foradil Certihaler. We believe that this approval validates SkyePharma's inhalation technology and paves the way to future products."
The UK company will earn what a spokeswoman for SkyePharma told PharmaTimes World News was "an upper single-digit royalty" on sales of the product, and she confirmed that talks are ongoing with Novartis with regards to commercial launches. Foradil Certihaler has been approved in 27 countries outside the USA.
The news rounds off a good month for SkyePharma which recently announced that its actinic keratosis product, Solaraze (diclofenac) has been given approval in Australia. The company said its marketing partner in Australia, Shire Pharmaceuticals, hopes to launch Solaraze in early 2007 and SkyePharma said it will receive double-digit royalty payments on net sales once the product hits the market.
The company also has an interest in Abbott Laboratories’ recently-completed acquisition of Kos Pharmaceuticals as the latter is developing a combination asthma medication called Flutiform (formoterol and fluticasone), in-licensed from SkyePharma, which is currently in late-stage trials.