SkyePharma has confirmed that it has completed all the clinical work required for filing of the New Drug Application for the firm’s flagship asthma combination drug Flutiform in the USA.

In an interim management statement, covering July 1 to September 30, the drug delivery specialist said that it is on track to file the NDA for Flutiform (fluticasone and formoterol) with the US Food & Drug Administration in the first quarter of 2009. Last week, SkyePharma announced what it described as “excellent top-line results” from its final Phase III efficacy study for the combo and chief executive Ken Cunningham said that with “growing revenues from across our portfolio and declining costs for the development of Flutiform, we continue to focus on moving SkyePharma towards long-term profitable growth”.

With regards to revenues, the company said that, “as in the first half of the year”, revenues since July “continue to show significant growth compared with the 2007 run rate”. The rise has been primarily driven by increases in contract R&D, plus an increase in royalty income following the launches of AstraZeneca’s inhaled corticosteroid Pulmicort HFA-MDI (budesonide), Schiele Pharma’s blood pressure drug Sular (nisoldipine) and GlaxoSmithKline’s Parkinson’s disease treatment Requip Once-a-day (ropinirole).

However, SkyePharma is unlikely to get much more cash out of its pact with GSK has on the antidepressant Paxil CR (paroxetine controlled-release). Mylan launched a generic erosion in May and the take-up “has been, as expected, quite rapid”, the firm noted. By the end of August, 80% of new prescriptions and 75% of total prescriptions were being written for the copycat version of Paxil CR.

Prospects for the firm look pretty healthy seeing as how SkyePharma recently finalised the new terms of the 2024 and 2025 convertible bonds, deferring the earliest dates at which the bondholders may call for repayment to November 2013 and December 2014 respectively. It also completed placement, raising £18.4 million.