SkyePharma posts six-month results

The pharmaceutical company posted revenue from continuing operations of £19.7m and lost £4.4m from discontinued operations. The London-based company has moved to focus on its oral and inhalation products and drug delivery technologies after selling its flailing injectables business to financial investment group Blue Acquisition​ in March for more that $80m. SkyePharma's key product, anticipated to be a potential $1bn-a-year blockbuster, is the asthma treatment Flutiform (fluticasone/formoterol), which was due to have a New Drug Application (NDA) submitted to the US Food and Drug Administration (FDA) in the first quarter of next year, but met an "unexpected"​ set back earlier this year during a pre-NDA meeting with the FDA. The FDA requested an additional clinical study be completed to provide additional efficacy data. The request would now see the NDA submission delayed until the second half of 2008, which is expected to cost the company between £3m and £5m. Despite the setback, the company has remained positive and confident in Flutiform's approval. "Substantial progress has been made in the first half to reshape the Group, focus the activity on oral and inhalation products, ensure that the company has adequate financial resources to meet its objectives, and ensure the timely completion of the Flutiform Phase III programme,"​ SkyePharma non-executive chairman Dr Jerry Karabelas said in a statement. "Although there is an unexpected delay to the planned date for filing Flutiform in the US to the second half of 2008, the board continues to have confidence in the potential for significant growth being created for shareholders in the coming years. This growth will arise from the commercialisation of Flutiform by our partners, the continued contribution from the royalties of our 11 approved products, and the further development of our pipeline." ​ The six-month revenue to June 30, 2007 was eight per cent below the £21.4m reported for the same six-month period in 2006. The company primarily put the reduction down to exchange rate fluctuations. Flutiform is still currently in Phase III trials, though the long-term safety study has been completed and the data will be used to support regulatory filings. Results from three efficacy trials are expected in the first quarter of 2008. The European clinical trials for the product were on track, the company said, with regulatory filings expected for the end of next year. The European trials include extending the indication to paediatric patients and to a higher dose strength. The clinical trial programme for the company's new formulation of Sular, (nisoldipine CR), a calcium channel blocking agent for the treatment of high blood pressure being developed with Sciele Pharma, was completed in May. Sciele filed a supplemental NDA with the FDA at the end of June which has a Prescription Drug User Fee Act (PDUFA) date of 2 November 2007. Launch is expected in 2008. The company plans to move into operating profit before tax during the course of 2008 and into profit after tax in 2009.