SkyePharma reduces losses and posts increased revenue

SkyePharma's revenues for the first half grew by 44% to £28.4 million despite generic competition to its antidepressant Paxil CR (paroxetine), which is marketed byGlaxoSmithKline, being introduced in the US by Mylan Pharmaceuticalsin May.

The increase in revenues was largely due to the growth in royalties and manufacturing revenues from the launch of recently approved products and additional contract development revenues.

The company reduced its pretax losses by 54% to £6.4 million. Pretax losses last year grew to more than half of SkyePharma's revenues at £24 million, due to increased R&D expenses relating to the asthma product Flutiform (formoterol plus fluticasone; Scrip Online, March 28th, 2008). However, the company reduced its R&D expenses in the first half of this year by 23% to £10.6 million.

Flutiform met the primary endpoints in all the studies in its core clinical programmes and an additional clinical efficacy study required for an NDA was fully recruited last month. SkyePharma expects the NDA to be filed in the US early next year. Positive Flutiform data have now been received from seven Phase III clinical studies and the company remains on track to launch in both the US and Europe in 2010, said Jeremy Scudamore, SkyePharma's non-executive chairman. The company signed an exclusive development, distribution and licensing agreement with Kyorinin April, for which it received an up-front milestone payment.

SkyePharma expects its revenue growth to continue, with sales of the once-daily form of the dopamine agonist Requip (ropinirole), which was launched in the US last month, as well as Pulmicort HFA-MDI (budesonide), which was recently approved in Europe, and Zyflo CR (zileuton).

SkyePharma posted a loss per share of £0.08 and on June 30th had cash and cash equivalents of £21.3 million, which the company's board believes will be enough for it to continue its operations for the foreseeable future.